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Watch and learn—on demand: Video modules on Verzenio, a CDK4 & 6 inhibitor.

Verzenio Vision™ video modules are made for busy healthcare providers like you. Watch leading oncology experts cover topics about Verzenio, a CDK4 & 6 inhibitor. With Verzenio Vision, you can jump in, access the specifics you need about Verzenio, and get on with your day.

Verzenio Vision

Featured peer insights

Peter A. Kaufman, MD

Overall Survival Results for Verzenio in Combination with Fulvestrant

00:00 - 00:17

[Music with a medium beat begins, in and under. Logo, title and disclaimers animate into view]

00:18 - 01:04

[Thought leader, his title, and institutional affiliation appear on screen]

Hello!

My name is Peter Kaufman, and I am a breast oncologist at the University of Vermont Cancer Center and a professor of medicine at the Larner College of Medicine at the University of Vermont in Burlington.

I am also a co-investigator for the MONARCH 2 trial that we'll be discussing today, as well as a coauthor on a number of publications for this trial.

I'm pleased to share with you the intriguing results for Verzenio® (abemaciclib) plus fulvestrant, in women with hormone receptor-positive, HER2-negative metastatic breast cancer, regardless of menopausal status.1,2

In this video, I will highlight the positive overall survival results for Verzenio plus fulvestrant in women with disease recurrence or progression following prior endocrine therapy.1,2

01:05 - 01:44

[Verzenio indication appears on screen]

Verzenio is indicated for the treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in combination with fulvestrant for adult patients with disease progression following endocrine therapy.1

Before we begin our discussion, I'd like to remind you to please refer to the Important Safety Information and the full Prescribing Information regarding warnings and precautions about the use of Verzenio, like diarrhea, neutropenia, interstitial lung disease and/or pneumonitis, hepatotoxicity, venous thromboembolism, and embryo-fetal toxicity.1

01:45 - 01:52

[Thought leader appears on screen, addressing the camera]

At this time, let's recap the study design for the pivotal trial that evaluated Verzenio in combination with fulvestrant.

01:53 - 02:58

[Thought leader split screen with MONARCH 2 trial design]

MONARCH 2 was a phase 3 randomized, double-blind, placebo-controlled trial.1

In this trial, Verzenio plus fulvestrant vs fulvestrant alone was evaluated in 669 women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer who had disease recurrence or progression following prior endocrine therapy.1,3

Eligible patients had not received chemotherapy in the metastatic setting. Patients also had not received more than 1 prior endocrine regimen in the metastatic setting.1,3

Pre- or perimenopausal women were allowed and were rendered postmenopausal prior to study enrollment.1,3 And lastly, all patients enrolled had received no prior treatment with a CDK 4/6 inhibitor.3

Progression-free survival was the primary endpoint in this trial, with overall survival, objective response rate, and duration of response as the key secondary endpoints.1,3

Now, let's take a look at the results for the primary and secondary endpoints in the intent-to-treat population.

02:59 - 03:43

[MONARCH 2 trial results on screen]

In MONARCH 2, Verzenio plus fulvestrant met its primary endpoint and demonstrated significant improvement in median progression-free survival compared with fulvestrant alone.1

The median progression-free survival was 16.4 months in patients treated with Verzenio plus fulvestrant vs 9.3 months in patients receiving fulvestrant alone. The hazard ratio was 0.553, with a statistically significant P-value of less than 0.0001 with a 95% confidence interval below one.1

The percentage of events at the time of analysis was 49.8 in the Verzenio plus fulvestrant arm and 70.4 in the fulvestrant alone arm.1

03:44 - 04:29

[MONARCH 2 trial results on screen (cont'd)]

This trial also met its secondary endpoint of overall survival, demonstrating meaningful results in the intent-to-treat population, with a 46.7-month median overall survival for patients receiving Verzenio plus fulvestrant vs 37.3 months for patients treated with fulvestrant alone.2

The hazard ratio was 0.757, and the P-value was 0.0137, which meets statistical significance; note that the 95% confidence interval does fall below one.2

The percentage of deaths at the time of analysis was 47.3 percent in patients receiving Verzenio plus fulvestrant vs 57.0 percent in patients treated with fulvestrant alone.2

04:30 - 04:46

[Thought leader appears on screen, addressing the camera]

So with Verzenio plus fulvestrant, women lived 9.4 months longer than patients receiving fulvestrant alone, with a median overall survival of almost 4 years.2

These results are based on a preplanned interim analysis and are considered to be definitive.2

04:47 - 05:41

[Select important safety information for Verzenio appears on screen]

It is important to note that severe diarrhea associated with dehydration and infection occurred in patients treated with Verzenio.1

In Verzenio-treated patients across 4 clinical studies, diarrhea occurred in 81 to 90% of patients and Grade 3 diarrhea occurred in 8 to 20%.1

Most patients experienced diarrhea during the first month of Verzenio treatment and the time to onset and resolution for diarrhea were similar: the median time to onset of first event of any grade was 8 days or less and median duration of Grade 2 of Grade 3 event was 11 days or less.1

Across trials, 19% to 26% of patients required a Verzenio dose interruption and 13% to 23% required a dose reduction.1

05:42 - 06:20

[Select important safety information for Verzenio appears on screen]

Therefore, it is important to instruct patients to start antidiarrheal therapy, such as loperamide, at the first sign of loose stools, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow-up.1

I recommend to my patients to have an over-the-counter antidiarrheal medicine available before they start taking Verzenio.1

For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, discontinue Verzenio until toxicity resolves to ≤Grade 1, and then resume Verzenio at the next lower dose.1

06:21 - 06:35

[Thought leader appears on screen, addressing the camera]

Verzenio has also demonstrated consistent progression-free survival and overall survival results in patients with primary endocrine resistance and with visceral disease, which are clinical characteristics that could confer a less favorable prognosis.1-3,5-9

06:36 - 06:49

[Thought leader split screen with graphic]

Primary resistance was defined as a relapse within 2 years of completion of adjuvant endocrine therapy or progressive disease within the first 6 months of first-line endocrine therapy for metastatic breast cancer.1

06:50 - 07:02

[Thought leader split screen with graphic]

Visceral disease is defined as 1 or more lesions in an internal organ on, or in, a third space, thus including the lung, liver, pleural, or peritoneal metastatic involvement.10

07:03 - 07:31

[Thought leader appears on screen, addressing the camera]

Before we discuss the subgroup data, please keep in mind that:

The preplanned subgroup analyses of progression-free survival and overall survival were performed incorporating stratification factors of disease site, including visceral disease, and endocrine sensitivity, including primary endocrine resistance. The analyses were not adjusted for multiplicity, and the study was not powered to test the effect of Verzenio plus fulvestrant among subgroups.2,9

07:32 - 07:48

[Thought leader split screen with graphic]

In the MONARCH 2 study, 25% of women had primary endocrine resistance.3,9

Now, let's review the results of the preplanned subgroup analyses of progression-free survival and overall survival in this population.

07:49 - 08:08

[Preplanned subgroup analyses graphic shown]

The median progression-free survival in women with primary endocrine resistance was consistent with the intent-to-treat population, at 15.3 months in patients treated with Verzenio plus fulvestrant vs 7.9 months in patients receiving fulvestrant alone. The hazard ratio was 0.454.3,9

08:09 - 08:30

[Preplanned subgroup analyses graphic shown]

Verzenio plus fulvestrant also demonstrated a 7.2-month numerical increase in median overall survival in this subgroup,2 at 38.7 months in patients treated with Verzenio plus fulvestrant vs 31.5 months in patients on fulvestrant alone. The hazard ratio was 0.686.2

08:31 - 08:37

[Thought leader split screen with graphic]

Now, turning to results in women with visceral disease. In this trial, 56% of women had visceral disease.3,9

08:38 - 08:57

[Preplanned subgroup analyses graphic shown]

In women with visceral disease, the median progression-free survival results were also consistent with the intent-to-treat population, at 14.7 months in patients treated with Verzenio plus fulvestrant vs 6.5 months in patients receiving fulvestrant alone. The hazard ratio was 0.481.9

08:58 - 09:20

[Preplanned subgroup analyses graphic shown]

Verzenio plus fulvestrant also demonstrated an 8.1-month numerical increase in median overall survival in women with visceral disease: the median overall survival is 40.3 months in patients receiving Verzenio plus fulvestrant vs 32.2 months in patients treated with fulvestrant alone. This hazard ratio is 0.675.2

09:21 - 09:34

[Thought leader appears on screen]

To reiterate, Verzenio plus fulvestrant prolongs overall survival in the study population, and consistent results were demonstrated in patients with primary endocrine resistance as well as visceral disease.1-3,5-9

09:35 - 10:27

[Select important safety information for Verzenio appears on screen]

Before I share more data for Verzenio, please be aware of warnings and precautions associated with Verzenio use:

Neutropenia, including febrile neutropenia and fatal neutropenic sepsis, is important to monitor for and manage during treatment with Verzenio.1

In Verzenio-treated patients across 4 clinical studies, neutropenia occurred in 37 to 46% of patients and Grade 3 or higher events occurred in 19% to 32%.1

The median time to first episode of Grade 3 or higher neutropenia was 29 to 33 days and the median duration was 11 to 16 days.1

Febrile neutropenia has been reported in less than 1% of patients exposed to Verzenio across trials and two deaths due to neutropenic sepsis were observed in MONARCH 2.1

10:28 - 10:55

[Select important safety information for Verzenio appears on screen]

Therefore, it is vital to inform patients to promptly report any episodes of fever to their healthcare provider. Additionally, monitor complete blood counts prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated.1

For patients who develop Grade 3 or 4 neutropenia, dose interruption, dose reduction, or delay in starting treatment cycles is recommended.1

10:56 - 11:41

[Select important safety information for Verzenio appears on screen]

Severe, life-threatening, or fatal interstitial lung disease or pneumonitis can occur in patients treated with Verzenio and other CDK 4/6 inhibitors.1

In Verzenio-treated patients in the adjuvant setting, 3% of patients experienced ILD or pneumonitis or any grade: 0.4% were Grade 3 or 4 events and there was one fatality.1

In Verzenio-treated patients across 3 trials in the metastatic setting, 3.3% of patients had interstitial lung disease and/or pneumonitis of any grade: 0.6% had Grade 3 or 4, and 0.4% had fatal outcomes. In the post-marketing setting, additional cases have been observed, with fatalities reported.1

11:42 - 12:06

[Select important safety information for Verzenio appears on screen]

It is very important to monitor patients for pulmonary symptoms indicative of interstitial lung disease and/or pneumonitis, which may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiographic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded by means of appropriate investigations.1

12:07 - 12:21

[Select important safety information for Verzenio appears on screen]

Dose interruption or dose reduction is recommended in patients who develop persistent or recurrent Grade 2 ILD or pneumonitis. Permanently discontinue Verzenio in all patients with Grade 3 or 4 ILD or pneumonitis.1

12:22 - 12:38

[Thought leader appears on screen]

Now let's review some additional data for Verzenio.

Time to chemotherapy and chemotherapy-free survival in the MONARCH 2 study were also evaluated in exploratory analyses. These analyses were not controlled for type 1 error, and the study was not powered to test these endpoints.11

12:39 - 13:14

[Exploratory analyses graphic shown]

Note that time to chemotherapy is defined as time from randomization to initiation of first study postdiscontinuation chemotherapy. The 111 patients who died prior to receiving chemotherapy did not contribute an event to this analysis.11

The median time to first study postdiscontinuation chemotherapy in patients treated with Verzenio plus fulvestrant was 50.2 months vs 22.1 months in patients receiving fulvestrant alone. This hazard ratio was 0.625.11

13:15 - 13:39

[Exploratory analyses graphic shown]

Chemotherapy-free survival is defined as the time from randomization to initiation of first study postdiscontinuation chemotherapy or death.11

The median chemotherapy-free survival in patients receiving Verzenio plus fulvestrant was 25.5 months vs 18.2 months in patients receiving fulvestrant alone.

The hazard ratio was 0.638.11

13:40 - 13:50

[Thought leader appears on screen]

As a reminder, in addition to overall survival, objective response rate and median duration of response were the other key secondary endpoints in this trial.1,3

13:51 - 14:42

[Objective response rate graphic shown]

Verzenio plus fulvestrant has demonstrated improvements in the objective response rate in patients with measurable disease: the objective response rate was 48.1% in patients treated with Verzenio plus fulvestrant vs 21.3% for those receiving fulvestrant alone.1,3

The median duration of response was 22.8 months with Verzenio plus fulvestrant vs 13.9 months with fulvestrant alone.1,3

In regard to the duration of response data, please note that there was no prespecified statistical procedure controlling for type 1 error3 and that the post hoc analysis of the intent-to-treat population was based on 158 women in the Verzenio plus fulvestrant arm and 37 women in the fulvestrant alone arm who had a best partial or complete response.12

14:43 - 15:13

[Thought leader appears on screen]

To summarize, compared with fulvestrant alone, Verzenio plus fulvestrant significantly extends overall survival and progression-free survival, and has shown a higher objective response rate in women with hormone-receptor positive, HER2-negative metastatic breast cancer with disease progression following prior endocrine therapy.1-3,5-9

I encourage you to explore the other modules to learn more about Verzenio and I hope this information has been helpful as you consider treatment recommendations for your patients.

15:14 - 15:16

[Music plays while summary appears on screen]

15:17 - 16:31

[Music plays while scrolling Important Safety Information appears on screen]

16:32 - 16:53

[Music with a medium beat begins, in and under. Closing art card shown.]

References

  1. Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company.
  2. Data on File. Lilly USA, LLC, DOF-AL-US-0088.
  3. Sledge GW Jr, Toi M, Neven P, et al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2– advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35:2875-2884.
  4. Data on file. Lilly USA, LLC. ONC20170608e.
  5. Solomayer EF, Diel IJ, Meyberg GC, Gollan C, Bastert G. Metastatic breast cancer: clinical course, prognosis and therapy related to the first site of metastasis. Breast Cancer Res Treat. 2000;59:271-278.
  6. Imkampe A, Bendall S, Bates T. The significance of the site of recurrence to subsequent breast cancer survival. Eur J Surg Oncol. 2007;33:420-423.
  7. Largillier R, Ferrero JM, Doyen J, et al. Prognostic factors in 1038 women with metastatic breast cancer. Ann Oncol. 2008;19:2012-2019.
  8. Cardoso F, Senkus E, Costa A, et al. 4th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4). Ann Oncol. 2018;29:1634-1657.
  9. Data on file. Lilly USA, LLC. ONC20180103a.
  10. Data on file. Lilly USA, LLC. ONC20171128a.
  11. Data on file. Lilly USA, LLC. DOF-AL-US-0089.
  12. Data on file. Lilly USA, LLC. ONC20180126a.

PP-AL-US-3092 08/2022
© Lilly USA, LLC 2022. All rights reserved.
Verzenio® is a registered trademark and Verzenio Vision™ is a trademark owned or licensed by Eli
Lilly and Company, its subsidiaries or affiliates.

Savings and patient support

Kristi K. Orbaugh, RN, MSN, RNP, AOCN

Personalized support through every step of treatment

Verzenio Continuous Care™ offers personalized support for your patients throughout their treatment with Verzenio. Learn more about the options this program offers in the video.

00:00 - 00:05

[Opening message fades in]

00:05 - 00:23

[Music beat, in and under. Logo, title, and disclaimer animate into view then fades to thought leader]

00:23 - 01:11

[Thought leader shown on-screen with lower-third graphic]

Thought leader: Hello, I'm Kristi Orbaugh, adult nurse practitioner at Community Hospital North in Indianapolis, Indiana.

Currently in my practice, I provide care to patients who don't always have a strong emotional support system in place. One of my patients is a single woman who has no children, relies on public transportation for travel, and has a physically demanding job. Although very independent, she takes comfort in the call from the Verzenio Continuous Care™ agent, and appreciates being in control of when those calls happen.

So, I would like to take this opportunity to tell you more about this program that can provide personalized support for your patients, after you have determined that Verzenio®, abemaciclib, is right for them.

01:12 - 01:22

[Service program logo and disclaimer build on screen.]

Thought leader: Introducing Verzenio Continuous Care™: a program that provides patients with continuity of care throughout their Verzenio treatment …

01:23 - 01:41

[Service icons for services appear as they are spoken to]

Thought leader: … including assistance with insurance and coverage, a savings card, free loperamide, the MyRightDose exchange program, and access to emotional support through a Companion in Care™. Note that this program is not a guarantee of coverage and that terms and conditions apply.

01:41 - 01:48

[Section title builds on screen.]

01:48 - 01:56

[Animated woman and 3 question marks build on screen]

Thought leader: The insurance coverage process can sometimes be complex and overwhelming for patients, but Verzenio Continuous Care can help.

01:56 - 02:14

[Magnifying glass uncovers questions, revealing coverage, pharmacy, and savings card icons]

Thought leader: A benefits investigator works with the insurance provider to help patients understand their coverage options, locate the most convenient pharmacy, and identify the lowest out-of-pocket cost available.

This service is even available for patients with Medicare Part D.

02:16 - 02:24

[Dollar sign icon and legal disclaimer build into view]

Thought leader: Paying for treatment shouldn't be an additional concern for your patients, and a savings card is available to help minimize out-of-pocket cost.

02:24 - 02:35

[Dollar sign icon and legal disclaimer build into view]

Thought leader: Eligible commercially insured patients can receive Verzenio for as little as $0 per month; note that governmental beneficiaries are not eligible.

02:35 - 02:41

[Section title builds on screen]

02:41 - 02:50

[Provider and patient discussion icons animate, and blister pack graphic appears]

Thought leader: To ensure your patients have loperamide before they start treatment, prescribers have the opportunity to request a one-time supply at no cost.

02:51 - 02:59

[Scene refreshes again; reintroduce Companion in Care icon.]

Thought leader: Additionally, your patients can be supported by a Companion in Care when starting Verzenio and for as long as they continue this treatment.

02:59 - 03:05

[Section title builds on screen]

03:05 - 03:10

[Companion in Care icon shown.]

Thought leader: When starting treatment, the Companion in Care can help clarify treatment expectations.

03:10 - 03:26

[Icons for services appear as they are spoken to]

Thought leader: As the treatment journey continues, your patients will receive help from the same person every time who provides emotional support, answers questions about side effects, and guides patients back to your practice for any medical advice.

03:27 - 03:39

[3-month icons branch out from Companion in Care, and dates are marked on the calendar]

Thought leader: Initially, Companions in Care will schedule three follow-up phone calls, and your patients can control the frequency of those interactions based on personal preferences and needs.

03:40 - 03:49

[MyRightDose icon and dosage graphics animate into view]

Thought leader: To ensure patients don't pay for another prescription should a dose reduction be required, the MyRightDose exchange program …

03:49 - 03:55

[MyRightDose icon remains, and a clock icon animates in and reveals “48.”]

Thought leader: … delivers the appropriate dose to your patients in as little as 48 hours, at no extra cost.

03:55 - 04:06

[ MyRightDose icon remains, pages of a calendar fall out, showing three separate instances of dose reductions.]

Thought leader: This program is available to patients who are prescribed Verzenio for an FDA-approved indication, for up to three separate dose reductions in a 12-month period.

04:07 - 04:16

[Icons representing support options shown on screen]

Thought leader: Visit the Savings & Support tab at verzenio.com to enroll your patients for support that is tailored to their entire treatment journey.

04:18 - 04:26

[Thought leader shown on-screen]

Thought leader: On behalf of Lilly and myself, thank you for your time. To learn more about Verzenio, please select another module.

04:26 - 04:36

[Video concludes with closing graphic]

PP-AL-US-2446 04/2022
© Lilly USA, LLC 2021. All rights reserved.
Verzenio® is a registered trademark and Verzenio Vision™, Verzenio Continuous Care™, and
Companion in Care™ are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or
affiliates.

IMPORTANT SAFETY INFORMATION

Severe diarrhea associated with dehydration and infection occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, diarrhea occurred in 81 to 90% of patients who received Verzenio. Grade 3 diarrhea occurred in 8 to 20% of patients receiving Verzenio. Most patients experienced diarrhea during the first month of Verzenio treatment. The median time to onset of the first diarrhea event ranged from 6 to 8 days; and the median duration of Grade 2 and Grade 3 diarrhea ranged from 6 to 11 days and 5 to 8 days, respectively. Across trials, 19 to 26% of patients with diarrhea required a Verzenio dose interruption and 13 to 23% required a dose reduction.

Instruct patients to start antidiarrheal therapy, such as loperamide, at the first sign of loose stools, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow-up. For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, discontinue Verzenio until toxicity resolves to ≤Grade 1, and then resume Verzenio at the next lower dose.

Neutropenia, including febrile neutropenia and fatal neutropenic sepsis, occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, neutropenia occurred in 37 to 46% of patients receiving Verzenio. A Grade ≥3 decrease in neutrophil count (based on laboratory findings) occurred in 19 to 32% of patients receiving Verzenio. Across trials, the median time to first episode of Grade ≥3 neutropenia ranged from 29 to 33 days, and the median duration of Grade ≥3 neutropenia ranged from 11 to 16 days. Febrile neutropenia has been reported in <1% of patients exposed to Verzenio across trials. Two deaths due to neutropenic sepsis were observed in MONARCH 2. Inform patients to promptly report any episodes of fever to their healthcare provider.

Monitor complete blood counts prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.

Severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis can occur in patients treated with Verzenio and other CDK4/6 inhibitors. In Verzenio-treated patients in EBC (monarchE), 3% of patients experienced ILD or pneumonitis of any grade: 0.4% were Grade 3 or 4 and there was one fatality (0.1%). In Verzenio-treated patients in MBC (MONARCH 1, MONARCH 2, MONARCH 3), 3.3% of Verzenio-treated patients had ILD or pneumonitis of any grade: 0.6% had Grade 3 or 4, and 0.4% had fatal outcomes. Additional cases of ILD or pneumonitis have been observed in the postmarketing setting, with fatalities reported.

Monitor patients for pulmonary symptoms indicative of ILD or pneumonitis. Symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded by means of appropriate investigations. Dose interruption or dose reduction is recommended in patients who develop persistent or recurrent Grade 2 ILD or pneumonitis. Permanently discontinue Verzenio in all patients with Grade 3 or 4 ILD or pneumonitis.

Grade ≥3 increases in alanine aminotransferase (ALT) (2 to 6%) and aspartate aminotransferase (AST) (2 to 3%) were reported in patients receiving Verzenio. Across three clinical trials in 3559 patients (monarchE, MONARCH 2, MONARCH 3), the median time to onset of Grade ≥3 ALT increases ranged from 57 to 87 days and the median time to resolution to Grade <3 was 13 to 14 days. The median time to onset of Grade ≥3 AST increases ranged from 71 to 185 days and the median time to resolution to Grade <3 ranged from 11 to 15 days.

Monitor liver function tests (LFTs) prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, dose discontinuation, or delay in starting treatment cycles is recommended for patients who develop persistent or recurrent Grade 2, or any Grade 3 or 4 hepatic transaminase elevation.

Venous thromboembolic events (VTE) were reported in 2 to 5% of patients across three clinical trials in 3559 patients treated with Verzenio (monarchE, MONARCH 2, MONARCH 3). VTE included deep vein thrombosis, pulmonary embolism, pelvic venous thrombosis, cerebral venous sinus thrombosis, subclavian and axillary vein thrombosis, and inferior vena cava thrombosis. In clinical trials, deaths due to VTE have been reported in patients treated with Verzenio.

Verzenio has not been studied in patients with early breast cancer who had a history of VTE. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate. Dose interruption is recommended for EBC patients with any grade VTE and for MBC patients with a Grade 3 or 4 VTE.

Verzenio can cause fetal harm when administered to a pregnant woman, based on findings from animal studies and the mechanism of action. In animal reproduction studies, administration of abemaciclib to pregnant rats during the period of organogenesis caused teratogenicity and decreased fetal weight at maternal exposures that were similar to the human clinical exposure based on area under the curve (AUC) at the maximum recommended human dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Verzenio and for 3 weeks after the last dose. Based on findings in animals, Verzenio may impair fertility in males of reproductive potential. There are no data on the presence of Verzenio in human milk or its effects on the breastfed child or on milk production. Advise lactating women not to breastfeed during Verzenio treatment and for at least 3 weeks after the last dose because of the potential for serious adverse reactions in breastfed infants.

The most common adverse reactions (all grades, ≥10%) observed in monarchE for Verzenio plus tamoxifen or an aromatase inhibitor vs tamoxifen or an aromatase inhibitor, with a difference between arms of ≥2%, were diarrhea (84% vs 9%), infections (51% vs 39%), neutropenia (46% vs 6%), fatigue (41% vs 18%), leukopenia (38% vs 7%), nausea (30% vs 9%), anemia (24% vs 4%), headache (20% vs 15%), vomiting (18% vs 4.6%), stomatitis (14% vs 5%), lymphopenia (14% vs 3%), thrombocytopenia (13% vs 2%), decreased appetite (12% vs 2.4%), ALT increased (12% vs 6%), AST increased (12% vs 5%), dizziness (11% vs 7%), rash (11% vs 4.5%), and alopecia (11% vs 2.7 %).

The most frequently reported ≥5% Grade 3 or 4 adverse reaction that occurred in the Verzenio arm vs the tamoxifen or an aromatase inhibitor arm of monarchE were neutropenia (19.6% vs 1%), leukopenia (11% vs <1%), diarrhea (8% vs 0.2%), and lymphopenia (5% vs <1%).

Lab abnormalities (all grades; Grade 3 or 4) for monarchE in ≥10% for Verzenio plus tamoxifen or an aromatase inhibitor with a difference between arms of ≥2% were increased serum creatinine (99% vs 91%; .5% vs <.1%), decreased white blood cells (89% vs 28%; 19.1% vs 1.1%), decreased neutrophil count (84% vs 23%; 18.7% vs 1.9%), anemia (68% vs 17%; 1% vs .1%), decreased lymphocyte count (59% vs 24%; 13.2 % vs 2.5%), decreased platelet count (37% vs 10%; .9% vs .2%), increased ALT (37% vs 24%; 2.6% vs 1.2%), increased AST (31% vs 18%; 1.6% vs .9%), and hypokalemia (11% vs 3.8%; 1.3% vs 0.2%).

The most common adverse reactions (all grades, ≥10%) observed in MONARCH 3 for Verzenio plus anastrozole or letrozole vs anastrozole or letrozole, with a difference between arms of ≥2%, were diarrhea (81% vs 30%), fatigue (40% vs 32%), neutropenia (41% vs 2%), infections (39% vs 29%), nausea (39% vs 20%), abdominal pain (29% vs 12%), vomiting (28% vs 12%), anemia (28% vs 5%), alopecia (27% vs 11%), decreased appetite (24% vs 9%), leukopenia (21% vs 2%), creatinine increased (19% vs 4%), constipation (16% vs 12%), ALT increased (16% vs 7%), AST increased (15% vs 7%), rash (14% vs 5%), pruritus (13% vs 9%), cough (13% vs 9%), dyspnea (12% vs 6%), dizziness (11% vs 9%), weight decreased (10% vs 3.1%), influenza-like illness (10% vs 8%), and thrombocytopenia (10% vs 2%).

The most frequently reported ≥5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of MONARCH 3 were neutropenia (22% vs 1%), diarrhea (9% vs 1.2%), leukopenia (7% vs <1%)), increased ALT (6% vs 2%), and anemia (6% vs 1%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 3 in ≥10% for Verzenio plus anastrozole or letrozole with a difference between arms of ≥2% were increased serum creatinine (98% vs 84%; 2.2% vs 0%), decreased white blood cells (82% vs 27%; 13% vs 0.6%), anemia (82% vs 28%; 1.6% vs 0%), decreased neutrophil count (80% vs 21%; 21.9% vs 2.6%), decreased lymphocyte count (53% vs 26%; 7.6% vs 1.9%), decreased platelet count (36% vs 12%; 1.9% vs 0.6%), increased ALT (48% vs 25%; 6.6% vs 1.9%), and increased AST (37% vs 23%; 3.8% vs 0.6%).

The most common adverse reactions (all grades, ≥10%) observed in MONARCH 2 for Verzenio plus fulvestrant vs fulvestrant, with a difference between arms of ≥2%, were diarrhea (86% vs 25%), neutropenia (46% vs 4%), fatigue (46% vs 32%), nausea (45% vs 23%), infections (43% vs 25%), abdominal pain (35% vs 16%), anemia (29% vs 4%), leukopenia (28% vs 2%), decreased appetite (27% vs 12%), vomiting (26% vs 10%), headache (20% vs 15%), dysgeusia (18% vs 2.7%), thrombocytopenia (16% vs 3%), alopecia (16% vs 1.8%), stomatitis (15% vs 10%), ALT increased (13% vs 5%), pruritus (13% vs 6%), cough (13% vs 11%), dizziness (12% vs 6%), AST increased (12% vs 7%), peripheral edema (12% vs 7%), creatinine increased (12% vs <1%), rash (11% vs 4.5%), pyrexia (11% vs 6%), and weight decreased (10% vs 2.2%).

The most frequently reported ≥5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of MONARCH 2 were neutropenia (25% vs 1%), diarrhea (13% vs 0.4%), leukopenia (9% vs 0%), anemia (7% vs 1%), and infections (5.7% vs 3.5%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 2 in ≥10% for Verzenio plus fulvestrant with a difference between arms of ≥2% were increased serum creatinine (98% vs 74%; 1.2% vs 0%), decreased white blood cells (90% vs 33%; 23.7% vs .9%), decreased neutrophil count (87% vs 30%; 32.5% vs 4.2%), anemia (84% vs 34%; 2.6% vs .5%), decreased lymphocyte count (63% vs 32%; 12.2% vs 1.8%), decreased platelet count (53% vs 15%; 2.1% vs 0%), increased ALT (41% vs 32%; 4.6% vs 1.4%), and increased AST (37% vs 25%; 3.9% vs 4.2%).

The most common adverse reactions (all grades, ≥10%) observed in MONARCH 1 with Verzenio were diarrhea (90%), fatigue (65%), nausea (64%), decreased appetite (45%), abdominal pain (39%), neutropenia (37%), vomiting (35%), infections (31%), anemia (25%), thrombocytopenia (20%), headache (20%), cough (19%), constipation (17%), leukopenia (17%), arthralgia (15%), dry mouth (14%), weight decreased (14%), stomatitis (14%), creatinine increased (13%), alopecia (12%), dysgeusia (12%), pyrexia (11%), dizziness (11%), and dehydration (10%).

The most frequently reported ≥5% Grade 3 or 4 adverse reactions from MONARCH 1 with Verzenio were diarrhea (20%), neutropenia (24%), fatigue (13%), and leukopenia (5%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 1 with Verzenio were increased serum creatinine (99%; .8%), decreased white blood cells (91%; 28%), decreased neutrophil count (88%; 26.6%), anemia (69%; 0%), decreased lymphocyte count (42%; 13.8%), decreased platelet count (41%; 2.3%), increased ALT (31%; 3.1%), and increased AST (30%; 3.8%).

Strong and moderate CYP3A inhibitors increased the exposure of abemaciclib plus its active metabolites to a clinically meaningful extent and may lead to increased toxicity. Avoid concomitant use of ketoconazole. Ketoconazole is predicted to increase the AUC of abemaciclib by up to 16-fold. In patients with recommended starting doses of 200 mg twice daily or 150 mg twice daily, reduce the Verzenio dose to 100 mg twice daily with concomitant use of strong CYP3A inhibitors other than ketoconazole. In patients who have had a dose reduction to 100 mg twice daily due to adverse reactions, further reduce the Verzenio dose to 50 mg twice daily with concomitant use of strong CYP3A inhibitors. If a patient taking Verzenio discontinues a strong CYP3A inhibitor, increase the Verzenio dose (after 3 to 5 half-lives of the inhibitor) to the dose that was used before starting the inhibitor. With concomitant use of moderate CYP3A inhibitors, monitor for adverse reactions and consider reducing the Verzenio dose in 50 mg decrements. Patients should avoid grapefruit products.

Avoid concomitant use of strong or moderate CYP3A inducers and consider alternative agents. Coadministration of strong or moderate CYP3A inducers decreased the plasma concentrations of abemaciclib plus its active metabolites and may lead to reduced activity.

With severe hepatic impairment (Child-Pugh C), reduce the Verzenio dosing frequency to once daily. The pharmacokinetics of Verzenio in patients with severe renal impairment (CLcr <30 mL/min), end stage renal disease, or in patients on dialysis is unknown. No dosage adjustments are necessary in patients with mild or moderate hepatic (Child-Pugh A or B) and/or renal impairment (CLcr ≥30-89 mL/min).

Please see full Prescribing Information for Verzenio.

AL HCP ISI 12OCT2021

INDICATIONS

VERZENIO (abemaciclib) is a kinase inhibitor indicated1:

  • in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.
  • in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
  • in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
  • as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
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