NEW YORK – Merck said this week that the US Food and Drug Administration has accepted a new drug application for the firm's HIF-2α inhibitor belzutifan to treat patients with renal cell carcinoma associated with von Hippel-Lindau (VHL), as defined by a germline VHL mutation. The NDA includes data from a Phase II clinical trial evaluating belzutifan in 61 patients with VHL disease-associated RCC who did not require immediate surgery. The overall response rate among these patients was a little more than 36 percent. The FDA has granted priority review for the application and has set a target action date of Sept. 15, 2021.
Separately this week, Merck and Eisai said that the combination of pembrolizumab (Merck's Keytruda) plus levatinib (Eisai's Lenvima) led to improved survival for previously treated advanced endometrial cancer patients regardless of mismatch repair status in the Phase III Keynote-775 trial. In the all-comer population, which included patients with both mismatch repair-proficient and -deficient tumors, the combination reduced the risk of death by 38 percent versus physician's choice of chemotherapy. The median progression-free survival was 7.2 months with the combination treatment versus 3.8 months with chemotherapy, and median overall survival was 18.3 months versus 11.4 months, respectively. Pembrolizumab plus levatinib previously received accelerated approval from the FDA for patients with advanced, previously treated endometrial cancers that are not microsatellite instability-high or dMMR. According to Merck, the results of the confirmatory Keynote-775 trial reaffirm this earlier decision.
Clovis Oncology said this week that in the randomized, Phase III ARIEL4 study, BRCA1/2-mutated, advanced ovarian cancer patients who had received at least two lines of chemotherapy and were treated with its PARP inhibitor rucaparib (Rubraca) had a median progression-free survival of 7.4 months compared to 5.7 months for those on chemotherapy. In the intent to treat population involving 233 patients on rucaparib and 116 patients on chemotherapy, the median progression-free survival was exactly the same. The US Food and Drug Administration granted accelerated approval to this indication in 2016 based on data from a single-arm trial involving 106 patients, and the data from this randomized study supports that earlier decision.
Liquid biopsy firm Grail said this week that it will work with AccessHope, a company that provides cancer expertise to employers and their healthcare partners, to ensure that patients and physicians have access to its Galleri cancer screening test when it launches later this year. AccessHope will provide various services, including access to a patient support team for guidance and information during the test process, as well as resources for physicians as they determine next steps to evaluate a positive Galleri test result. Galleri, which will require a prescription, will be available initially only through partner health systems, medical practices, and self-insured employers. Grail previously said it plans to launch the test in the second quarter of 2021. Financial terms of the agreement were not disclosed.
GenomOncology said this week that Cleveland, Ohio-based University Hospitals (UH) Seidman Cancer Center will adopt GenomOncology's Precision Decision and GO Connect platforms to help match cancer patients to clinical trials, including on the basis of molecular biomarkers. The platform will help UH identify appropriate therapies and relevant clinical trials for patients and perform feasibility analyses for opening clinical trials at UH locations.
Veracyte said this week that it has completed its acquisition of Decipher Biosciences. Tina Nova, formerly president and CEO of Decipher, has been appointed as general manager of urological cancers at Veracyte.
Amoy Diagnostics of Xiamen, China and Shanghai-based Haihe Biopharma recently announced an agreement to use the AmoyDx MET mutation detection kit as a companion diagnostic to support the registration of Haihe's MET kinase inhibitor glumetinib (SCC244) in the US. Under the terms of the agreement, AmoyDx will develop and register the AmoyDx MET Mutation Detection Kit in the US with the aim of obtaining FDA premarket approval as a CDx for glumetinib, which targets c-MET exon14 skipping alterations in people with non-small cell lung cancer.
Verastem Oncology said this week that its investigational MEK and pan-RAF inhibitor VS-6766 led to clinically meaningful responses among patients with recurrent, low-grade, serous ovarian cancer (LGSOC), regardless of KRAS mutation status in the Phase I/II FRAME study. Based on the new data, the company plans to expand the enrollment criteria for its registration-directed Phase II RAMP 201 study, evaluating VS-6766 alone and in combination with Verastem's FAK inhibitor defactinib. The trial will now enroll LGSOC patients with both KRAS-mutated and KRAS-wildtype tumors, an amendment to the trial's protocol.
Aspira Women's Health said this week that its wholly owned subsidiary Aspira Labs has been credentialed with the New York State Medicaid program for an additional 6.5 million Medicaid lives. As a result, the program will begin covering the company's OVA1 test on April 1, bringing the total coverage for the test to 179 million lives nationwide. The US Food and Drug Administration-cleared test assesses ovarian cancer risk for women with a pelvic mass.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.