Priority review designations in ovarian cancer, prostate cancer, and non—small cell lung cancer, encouraging findings in lung cancer, and regulatory decisions by the National Institute for Health and ¬Care Excellence.

Welcome to OncLive News Network! I'm Kristi Rosa.

The FDA has granted a priority review designation to a supplemental new drug application for the combination of olaparib and bevacizumab for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy with bevacizumab.

The decision is based on results from the phase III PAOLA-1 trial, in which the combination led to an investigator-assessed 41% reduction in the risk of disease progression or death compared with bevacizumab alone in this patient population. After a median follow-up of 22.9 months, the median progression-free survival was 22.1 months and 16.6 months with the combination and bevacizumab alone, respectively.

Results also showed that the benefit with olaparib was most pronounced in patients with tumors that were positive for homologous-recombination deficiency, including those that had BRCA mutations. In this subgroup, the median PFS was 37.2 months and 17.7 months with the olaparib combination and bevacizumab alone, respectively.

The FDA is expected to make a decision on the application in the second quarter of 2020.

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In prostate cancer, the FDA granted a priority review designation to a supplemental new drug application for rucaparib for the treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castration-resistant disease.

The application is based on findings from the ongoing phase II TRITON2 trial, in which the PARP inhibitor induced a 43.9% confirmed objective response rate by investigator assessment in 57 RECIST—evaluable patients with BRCA1/2-mutant mCRPC. Responses were durable, with 60% of responses lasting ≥24 weeks. Additionally, the confirmed prostate-specific antigen response was 52.0% in patients with mCRPC and a BRCA1/2 mutation.

Under the Prescription Drug User Fee Act, the FDA will make a decision on the application by May 15, 2020.

In October 2018, the FDA had granted rucaparib a breakthrough therapy designation for single-agent use in adult patients with BRCA1/2-positive mCRPC following at least 1 androgen receptor—directed therapy and taxane-based chemotherapy, based on the preliminary TRITON2 findings.

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The FDA has granted a priority review designation to a supplemental biologics license application for the combination of nivolumab and ipilimumab for the first-line treatment of patients with metastatic or recurrent non—small cell lung cancer that does not have EGFR or ALK genomic tumor aberrations.

The application is based on data from part 1 of the phase III CheckMate-227 trial, in which nivolumab plus ipilimumab demonstrated a significant improvement in overall survival versus chemotherapy alone in patients with previously untreated NSCLC.

In a cohort of patients with PD-L1 expression of 1% or higher, the median OS with nivolumab and ipilimumab compared with chemotherapy was 17.1 months and 14.9 months, respectively. Moreover, the median OS was 17.1 months with the combination and 13.9 months with chemotherapy in all randomized patients, regardless of PD-L1 expression status.

Moreover, in the cohort of patients with PD-L1 of 1% or higher expression, the 1- and 2-year OS rates were 63% and 40% with nivolumab/ipilimumab and 56% and 33% with chemotherapy, respectively.

The safety profile of the combination was also consistent with previously reported trials, and no new safety signals were observed. The FDA will decide on the application by May 15, 2020.

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Also in non—small cell lung cancer, an interim analysis of the Chinese, phase III ORIENT-11 trial showed that the first-line combination of sintilimab injection plus pemetrexed and platinum-based therapy showed a statistically significant improvement in progression-free survival versus chemotherapy and placebo in patients with advanced or recurrent disease who did not harbor EGFR or ALK abnormalities.

Results showed that the combination met the predefined efficacy criteria of the interim analysis, which was conducted by the Independent Data Monitoring Committee. The safety profile of sintilimab injection was found to be consistent with prior trials.

Full findings will be presented at an upcoming medical meeting. Furthermore, based on a recommendation from the IDMC, Eli Lilly and Company and Innovent, the companies that are jointly developing sintilimab and pemetrexed, regulatory discussions will be initiated with the National Medical Products Administration in China in the near future.

Sintilimab injection is a PD-1 inhibitor that has previously been granted marketing approval by the NMPA for patients with relapsed/refractory classical Hodgkin lymphoma following second-line chemotherapy.

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The National Institute for Health and Care Excellence has recommended the use of olaparib as a maintenance treatment in adults with relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer that has responded to platinum-based chemotherapy only if they harbor a BRCA1/2 mutation, they received 3 or more courses of platinum-based chemotherapy, and the manufacturer provides the agent according to the commercial arrangement.

Moreover, the PARP inhibitor was also recommended for use within the Cancers Drugs Fund as a maintenance treatment option in this patient population if they harbor a BRCA1/2 mutation, they previously received 2 courses of platinum-based chemotherapy, and the conditions in the managed access agreement for the PARP inhibitor are followed.

However, for those with BRCA-mutant disease who have only had 2 courses of platinum-based chemotherapy, the agent does not meet the agency’s criteria.

NICE also issued guidelines recommending against pembrolizumab for use in treatment-naïve patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma whose tumors express PD-L1 with a combined positive score of 1 or higher.

The agency also recommended against gilteritinib for patients with relapsed/refractory acute myeloid leukemia who harbor a FLT3 mutation.

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This week, we sat down Dr Sara Hurvitz, of University of California, Los Angeles, to discuss management of central nervous system metastases in HER2-positive metastatic breast cancer.

That’s all for today.

Thank you for watching OncLive News Network! I'm Kristi Rosa.