Verzenio® (Abemaciclib)

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Abemaciclib: ER+/PR- Patients

Abemaciclib efficacy data is available for patients with ER+ only disease.

MX_cFAQ_ABE061_ER+_PR-
MX_cFAQ_ABE061_ER+_PR-
en-US

Información Detallada

Estrogen Receptor Positive Patients

In the MONARCH 1, 2, and 3 clinical trials, patients were required to have HR+ disease to be included in the studies. Efficacy results are not provided by ER status; however, to fulfill the requirement of HR+ disease, a breast cancer must express, by immunohistochemistry, at least one of the HR (ER or PR). Therefore, efficacy results for PR- patients can be used as a surrogate marker for efficacy results of ER+ patients.1-4 

In the subgroup analyses of the MONARCH 2 and 3 trials, PR- tumor status was identified to be a poor prognostic factor compared to PR+ tumor status. Although the addition of abemaciclib provided benefit for patients regardless of prognosis or PR status, a larger benefit was seen in patients with poor prognostic factors, and therefore, patients with PR- tumors.5

Subgroup analysis for PR- patients in the MONARCH clinical trials is presented in Progesterone Receptor Negative Efficacy Results in the MONARCH Clinical Trials.

Progesterone Receptor Negative Efficacy Results in the MONARCH Clinical Trials4,5

MONARCH 3

MONARCH 2

MONARCH 1

Abemaciclib + NSAI

Placebo + NSAI

Abemaciclib + Fulvestrant

Placebo + Fulvestrant

Abemaciclib Monotherapy

Progesterone receptor negative patients, n

70

36

96

44

35

PFS, months 

27.5

9.4

16.3

7.4

---

Hazard Ratio (95% CI)

0.410 (0.246-0.685)

0.509 (0.325-0.797)

---

ORR (CR+PR), %

60.7a

27.6b

43.9c

9.7d

22.9

DoR, months

---

---

---

---

7.1

(95% CI)

---

---

---

---

4.7-8.9

Abbreviations: CR = complete response; DoR = duration of response; MD = measurable disease ; NSAI = nonsteroidal aromatase inhibitor; ORR = objective response rate; PFS = progression-free survival; PR = partial response.

aIn patients with MD (n=61).

bIn patients with MD (n=29).

cIn patients with MD (n=66).

dIn patients with MD (n=31).

References

1Dickler MN, Tolaney SM, Rugo HS, et al. MONARCH 1, a phase II study of abemaciclib, a CDK4 and CDK6 inhibitor, as a single agent, in patients with refractory HR+/HER2- metastatic breast cancer. Clin Cancer Res. 2017;23(17):5218-5224. http://dx.doi.org/10.1158/1078-0432.CCR-17-0754. Published correction appears in Clin Cancer Res. 2018;24(21):5475. http://clincancerres.aacrjournals.org/content/24/21/5485.article-info

2Sledge GW, 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(25):2875-2884. http://dx.doi.org/10.1200/JCO.2017.73.7585

3Goetz MP, Toi M, Campone M, et al. MONARCH 3: Abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35(32):3638-3646. https://doi.org/10.1200/jco.2017.75.6155

4Data on file, Eli Lilly and Company and/or one of its subsidiaries.

5Di Leo A, O'Shaughnessy J, Sledge GW, et al. Prognostic characteristics in hormone receptor-positive advanced breast cancer and characterization of abemaciclib efficacy. NPJ Breast Cancer. 2018;4(1):41. http://dx.doi.org/10.1038/s41523-018-0094-2

Glossary

ER = estrogen receptor

ER+ = estrogen receptor-positive

HR = hormone receptor

HR+ = hormone receptor-positive

PR = progesterone receptor

PR- = progesterone receptor-negative

PR+ = progesterone receptor-positive

Fecha de la última revisión: 2019 M02 07


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