Breast Cancer Drug Approval Tops Week in Cancer News


Top news of the week in oncology and cancer drug development.

FDA Approves Ribociclib for Frontline HR+/HER2- Breast Cancer

The FDA has approved the CDK 4/6 inhibitor ribociclib (Kisqali) for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone-receptor (HR)—positive, HER2-negative advanced breast cancer. The approval is based on findings from the phase III MONALEESA-2 trial, in which combining ribociclib with letrozole reduced the risk of progression or death by 44% compared with letrozole alone (HR, 0.556; 95% CI, 0.43-0.72; P <.0001).

The MONALEESA-2 trial enrolled 668 postmenopausal women with advanced breast cancer who had not yet received prior therapy for advanced disease. At a median follow-up of 15.3 months, the ribociclib group’s median progression-free survival (PFS) had yet to be reached, whereas the placebo group had an estimated median PFS of 14.7 months. Blinded PFS assessment by an independent review committee resulted in a hazard ratio of 0.59 in favor of the ribociclib arm (P = .002). After an additional 11 months of follow-up, a subsequent analysis showed that the median PFS was 25.3 months with the ribociclib combination versus 16 months with letrozole alone. Overall survival data are still not mature.

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Imatinib Continues to Impress in Long-Term CML Analysis

Imatinib (Gleevec) continued to show dramatic overall survival (OS) benefits after nearly 11 years of follow-up and despite crossover for patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML), according to long-term findings published in The New England Journal of Medicine. At a 10.9-year assessment of the phase III IRIS trial, the 10-year OS rate was 83.3% for 400-mg imatinib (95% CI, 80.1-86.6). Overall, 65.6% of patients crossed over to the imatinib arm from the control arm of interferon alfa plus cytarabine.

The median time to crossover was 0.8 years. The OS rate after 10 years for those treated with interferon alfa plus cytarabine was 78.8% (95% CI, 75.0-82.5). Despite the crossover, there was still a 26% reduction in the risk of death with imatinib (HR, 0.74; 95% CI, 0.56-0.99; P = .04). Earlier findings from the phase III trial changed practice for patients with CML, ushering in an era of precision medicine. At the 18-month analysis of the trial, which was also known as STI571, the complete cytogenetic response (CCyR) was 76.2% with imatinib versus 14.5% with interferon alfa plus cytarabine. After this analysis, most patients in the control arm crossed over to receive imatinib.

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New Rucaparib Data Presented at SGO Annual Meeting

The PARP inhibitor rucaparib slowed progression of relapsed BRCA-mutant ovarian cancer regardless of whether the mutations were somatic or germline, a new analysis of a phase II trial showed. Patients with germline or somatic BRCA mutations had a median progression-free survival (PFS) of about 13 months when treated with rucaparib.

Additionally, patients with BRCA1 or BRCA2-mutant disease had similar PFS with the PARP inhibitor. Patients with platinum-sensitive disease derived the most benefit from rucaparib, and PFS increased with the duration of the platinum-free interval, as reported at the 2017 Society of Gynecologic Oncology Annual Meeting. The findings came from an analysis of the ARIEL2 trial, which investigated the effect of single-agent rucaparib on PFS in patients with relapsed platinum-sensitive ovarian cancer and objective response rate in patients with relapsed, heavily pretreated ovarian cancer.

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Eribulin/Pembrolizumab Combo Effective for TNBC

The combination of eribulin (Halaven) and pembrolizumab (Keytruda) demonstrated promising objective response rates (ORR), including a complete response (CR), for patients with metastatic triple-negative breast cancer, according to findings from a phase Ib/II study presented at the 2017 Miami Breast Cancer Conference. In 39 evaluable patients at an interim analysis of the study, the ORR with the combination was 33.3% (95% CI, 19.5-48.1). The CR rate was 2.6% and 28.2% of patients had stable disease (SD) for ≥8 weeks, of which 7.7% was for ≥24 weeks.

The clinical benefit rate (CBR; ORR plus SD for ≥24 weeks) was 41%. In the study, 89 total patients with metastatic TNBC received eribulin at 1.4 mg/m2 on days 1 and 8 plus pembrolizumab at a flat dose of 200 mg every 3 weeks. The ORR with the combination for untreated patients with metastatic TNBC (n = 17) was 41.2% (95% CI, 19.3-62.8). The SD for ≥8 weeks rate was 17.6% and the CBR was 47.1%. In a cohort of patients pretreated with 1 to 2 therapies (n = 22), the ORR was 27.3% (95% CI, 11.3-46.4), which included the 1 CR. The SD for ≥8 weeks rate was 36.4% and the CBR was 36.4%. In patients with PD-L1—positive TNBC (n = 17), the ORR was 29.4% (95% CI, 11.1-51.1) and in those with PD-L1–negative disease (n = 18) the ORR was 33.3% (95% CI, 14.1-54.6). The 1 CR in the study was seen in a group of 4 patients with unavailable PD-L1 status.

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FDA Places Partial Clinical Hold on Selinexor Trials

The FDA has placed a partial clinical hold on trials of selinexor (KPT-330), which is being explored in several tumor types. Although the hold stops additional enrollment in the trials, patients who have achieved stable disease or better can continue treatment, according to Karyopharm, the company developing the agent.

“The FDA has indicated that the partial clinical hold is due to incomplete information in the existing version of the investigator's brochure (IB), including an incomplete list of serious adverse events associated with selinexor. At the FDA's request, Karyopharm has amended the IB and updated the informed consent documents accordingly and has submitted such documents to the FDA as requested,” Karyopharm reported in a statement.

The company noted the hold is not related to any new safety concerns. Now that the FDA has received the requested materials from Karyopharm, the agency will review the information and make a decision within 30 days on whether or not to lift the hold.

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Gottlieb Chosen to Head the FDA, Verma Confirmed as CMS Administrator

President Donald Trump has named Scott Gottlieb, MD, a resident scholar with the American Enterprise Institute, as his nominee to lead the FDA. Gottlieb has previously worked for the FDA as deputy commissioner of medical and scientific affairs.

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Additionally, the Senate voted 55-43 to confirm Seema Verma to run the CMS. Verma will take over the giant agency that operates Medicare and Medicaid and is the nation’s largest payer, setting policy for those programs and the blueprint that most other commercial plans follow.

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