Top news of the week in oncology and cancer drug development.
FDA Grants Brigatinib Priority Review for ALK-Positive NSCLC
The FDA has granted a priority review to a new drug application for brigatinib for patients with metastatic ALK-positive non—small cell lung cancer who are resistant to prior crizotinib. The NDA, which follows a breakthrough therapy designation that was received in October 2014, is based on findings from the phase II ALTA trial. In results from the trial presented at the 2016 ASCO Annual Meeting, the confirmed objective response rate for brigatinib at 180 mg daily was 54%.
Those who had not received chemotherapy had an ORR of 52%. There were 4 confirmed complete responses. The median progression-free survival was 12.9 months. The 1-year PFS rate was 54%. In those with measurable active brain metastases, the intracranial ORR was 67%. The median overall survival had not yet been reached but the 1-year OS rate was 80%. Under the Prescription Drug User Fee Act, the FDA is scheduled to make a final decision on the NDA by April 29, 2017.
Maintenance Olaparib Improves PFS in Phase III Ovarian Cancer Trial
Single-agent olaparib significantly improved progression-free survival compared with placebo in the maintenance setting for patients with advanced BRCA-positive ovarian cancer. Although specific data from the trial are not yet available, AstraZeneca reported that the median PFS with olaparib was significantly higher than in the olaparib arm of the phase II Study 19 in a similar population.
The safety profile for the PARP inhibitor was consistent with results reported from previous trials. In Study 19, the median PFS for patients taking maintenance olaparib was 8.4 months, compared to 4.8 months for the control group (HR, 0.35; P <.0001). The difference in the BRCA mutation subgroup was even more pronounced: 11.2 months with olaparib and 4.3 months with placebo (HR, 0.18; P <.0001). AstraZeneca said it would work with regulatory authorities to make olaparib available for maintenance use.
EMA Accepts Avelumab Application for Merkel Cell Carcinoma
The European Medicines Agency has accepted and validated a marketing authorization application for avelumab as a treatment for patients with metastatic Merkel cell carcinoma. The application was based on findings from the phase II JAVELIN Merkel 200 study, in which the objective response rate with avelumab was 31.8%, which included a 9.1% complete response rate.
After a median follow-up of 10.4 months, 82% of patients continued to respond to therapy. In addition to responses, 10.2% of patients had stable disease and 20.5% were not evaluable for response. Median progression-free survival with avelumab was 2.7 months. The 6-month PFS rate was 40%.
The median overall survival was 11.3 months and the 6-month OS rate was 69%. In the United States, avelumab has received a breakthrough therapy designation as a potential treatment for patients with Merkel cell carcinoma. An application for avelumab in Merkel cell carcinoma has also been submitted to the FDA.
CVS Reverses Course on Dispensary Exclusion Plan
CVS Health has changed its mind about excluding physician-owned dispensaries from Medicare Part D drug distribution. The Part D class includes the rising class of oral oncolytics, which are both lucrative and make up a growing proportion of oncology drugs prescribed. The pharmacy benefit manager owns a huge chain of 10,000 pharmacies through its corporate conglomerate and it had been accused by oncologists of trying to cut them out of business so it could capture a bigger slice of the oral oncolytics market.
A CVS spokeswoman Christine Cramer said that although the exclusion policy had been found to be in conformance with longstanding CMS policy, CVS was not going to go through with it. The implementation would have begun in January 2017 and Cramer said that CVS had already begun notifying physician dispensaries and beneficiaries of the decision to abandon its exclusion plan.
Nivolumab Benefit in Hodgkin Lymphoma Sustained in Longer Follow-up
Nivolumab had an objective response rate of 73% in a cohort of patients with classical Hodgkin lymphoma who received brentuximab vedotin before and/or after autologous hematopoietic stem cell transplantation, according to updated results from the CheckMate-205 trial that were presented at 10th International Symposium on Hodgkin Lymphoma.
The updated data are consistent with prior results from a separate CheckMate-205 cohort which supported the FDA’s May 2016 approval of nivolumab for patients with cHL who relapse or progress after AHSCT and post-transplantation brentuximab vedotin. In patients who received brentuximab vedotin before AHSCT, after AHSCT, or both, the ORRs were 70% (23/33; 95% CI, 51.3-84.4), 72% (41/57; 95% CI, 58.5-83), and 88% (7/8; 95% CI, 47.3-99.7), respectively.
The 6-month progression-free survival rate was 76.6%, the 6-month overall survival rate was 93.9%, and median PFS was 11.2 months.