FDA Approvals in Ovarian Cancer and Merkel Cell Carcinoma, Priority Review in Ovarian Cancer, and More
Today-
FDA approvals in ovarian cancer and Merkel cell carcinoma, a priority review in ovarian cancer, recommendations for European approvals of immunotherapy agents, and ASCO releases its State of Cancer Care Report.
Welcome to OncLive News Network! I’m Gina Columbus.
The FDA has approved the PARP inhibitor niraparib as a maintenance treatment for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
The decision was based on findings from the phase III NOVA trial, in which niraparib reduced the risk of progression or death by 74% versus placebo for patients with germline BRCA-positive platinum-sensitive, recurrent disease.
In the study, the median progression-free survival was 21 months with maintenance niraparib compared with 5.5 months for placebo in patients with germline BRCA mutations. The results were consistent across subgroups of patients, including those without BRCA mutations.
Tesaro, the manufacturer of niraparib, stated that it anticipates that niraparib will be officially launched in the United States in late April.
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In Merkel cell carcinoma, the FDA approved the PD-L1 inhibitor avelumab for the treatment of adult and pediatric patients 12 years and older with metastatic disease. This includes those who have not received prior chemotherapy.
The approval is based on data from the open-label phase II JAVELIN Merkel 200 study. Here, the objective response rate with avelumab was 33%, which included an 11.4% complete response rate and a 21.6% partial response rate. The duration of response was at least 6 months in 86% of patients, with 45% of patients having a DOR of 12 months or more.
Additionally, the median progression-free survival with avelumab was 2.7 months, and the 6-month PFS rate was 40%. The median overall survival was 11.3 months and the 6-month OS rate was 69%.
Avelumab is the first treatment approved by the FDA for metastatic Merkel cell carcinoma. Its accelerated approval is contingent upon the results of confirmatory trials.
Moreover, this is the first FDA approval for avelumab, which has also been granted a priority review for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed after platinum-based therapy.
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In ovarian cancer, a new drug application for olaparib has been granted a priority review designation by the FDA as a maintenance therapy in relapsed patients with platinum-sensitive disease.
The application is based on findings from the SOLO2 study, in which maintenance olaparib showed a 70% reduction in the risk of progression or death versus placebo for patients with platinum-sensitive, relapsed, BRCA-mutant ovarian cancer.
Results showed that patients randomized to olaparib had a median investigator-assessed progression-free survival of 19.1 months compared with 5.5 months in the placebo arm. A prespecified analysis of PFS by a blinded central review committee showed a median PFS of 30.2 months for the olaparib group versus 5.5 months for placebo, leading to a 75% reduction in the hazard for progression or death.
The indication for maintenance olaparib would be for an investigational tablet formulation of the PARP inhibitor that patients would receive at 300 mg twice daily.
Olaparib is currently FDA approved as a capsule formulation at 400 mg twice daily for the treatment of women with BRCA-positive advanced ovarian cancer following treatment with 3 or more prior lines of chemotherapy.
Under the Prescription Drug User Fee Act, the FDA will make a final approval decision on the maintenance application by the third quarter of 2017.
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Pembrolizumab has been recommended for approval by the European Medicine’s Agency Committee for Medicinal Products for Human Use as a treatment for adult patients with relapsed or refractory classical Hodgkin lymphoma. The indication would be for patients who progressed following autologous stem cell transplant and brentuximab vedotin, or who are transplant-ineligible and have failed brentuximab vedotin.
The recommendation is based on results from the phase II KEYNOTE-087 and phase Ib KEYNOTE-013 trials. In KEYNOTE-087, the overall response rate with pembrolizumab was 69% at a median 9.4-month follow-up. The ORR included complete responses in 22% of patients and partial responses in 47% of patients. The median duration of response was 11.1 months among the 145 responding patients.
Also in Europe, the CHMP has recommended approval of the PD-1 inhibitor nivolumab for the treatment of patients with squamous cell cancer of the head and neck following progression on platinum-based therapy.
This opinion is based on the CheckMate-141 study, in which the median overall survival with nivolumab was 7.5 months versus 5.1 months with investigator’s choice. The ORR was 13.3% versus 5.8%, respectively.
The European Commission will now review the recommendations and a final approval decision for use in the European Union is expected in about 2 months.
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Finally, in its annual State of Cancer Care in America report, the American Society of Clinical Oncology discussed how the Affordable Care Act has improved access to cancer care for millions of Americans, and many new drugs and new indications for existing cancer drugs were approved in 2016.
However, the report emphasized that there are critical remaining challenges in improving cancer care, including information barriers, disparities in the availability of rural care, and stressors on physicians and oncology practices.
One of the chief hurdles also looming is providing ongoing care for the rising numbers of Americans who are diagnosed with cancer and who are surviving their cancer, thanks to improved therapies.
ASCO said the number of cancer survivors is expected to grow by one-third, from 15.5 million in 2016 to 20.3 million by 2026.
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That’s all for today.
Thank you for watching OncLive News Network! I’m Gina Columbus.
