NEW YORK – AstraZeneca and Merck said this week that the Phase III OlympiA trial will move to early primary analysis upon the recommendation of an independent data monitoring committee. OlympiA is comparing the companies' PARP inhibitor olaparib (Lynparza) to placebo in BRCA1/2-mutated, HER2-negative, early-stage breast cancer patients who have had local treatment and neoadjuvant or adjuvant chemotherapy. AstraZeneca said that the IDMC determined during a planned interim analysis that invasive disease-free survival rates were superior in the olaparib arm compared to the placebo arm, and as such, the primary analysis can take place.
The Breast International Group, NRG Oncology, the National Cancer Institute, Frontier Science & Technology Research Foundation, AstraZeneca, and MSD are collaborating on OlympiA. NRG Oncology is sponsoring the study in the US, and AstraZeneca is sponsoring it outside the US. The researchers will present the full results at a future medical meeting.
The US Food and Drug Administration this week granted priority review to Amgen's new drug application for sotorasib as a treatment following systemic therapy for locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutations. Amgen submitted its NDA in December and the priority review designation places sotorasib on an expedited evaluation path. The company expects the FDA to issue a decision on its application on Aug. 16. The FDA has also designated sotorasib a breakthrough therapy and is reviewing Amgen's NDA within its Real-Time Oncology Review pilot program, which is aimed at bringing innovative therapies to market more efficiently.
San Diego-based Kintara Therapeutics this week said it has enrolled the final patient in an arm of a Phase II trial of VAL-083, involving patients with MGMT-unmethylated glioblastoma multiforme whose disease has recurred after temozolomide treatment. The trial, which is ongoing at MD Anderson Cancer Center, was designed to enroll up to 83 recurrent patients and assess if VAL-083 improves overall survival compared to historical controls. In November, Kintara reported that median overall survival was 7.6 months for 77 patients in the recurrent arm who had completed at least one cycle of treatment. The company will report topline results from the recurrent arm in the second quarter of 2021. The Phase II study also has a second arm evaluating VAL-083 as an adjuvant treatment for MGMT-unmethylated glioblastoma.
Caris Life Sciences said this week that the Dana Farber Cancer Institute has joined the Caris Precision Oncology Alliance. The alliance is a collaborative network of cancer centers that are working to advance comprehensive cancer profiling and establish standards for molecular testing in oncology through research on predictive and prognostic markers. At Dana Farber, the alliance will operate from the Lank Center for Genitourinary Oncology. The network currently includes more than 45 cancer centers and academic institutions, which have early access to Caris' database and artificial intelligence platform, as well as the Caris CODEai data solution, which has cancer treatment information and clinical outcomes data for more than 215,000 patients.
The LUNGevity Foundation said this week that it is launching an education campaign to improve access to genomic testing among non-small cell lung cancer patients. The foundation cited data that, as of 2019, only 22 percent of eligible advanced NSCLC patients were receiving testing for biomarkers to personalize their treatment with targeted drugs. The campaign, called "No One Missed," is financially supported by LUNGevity's pharmaceutical partners, AstraZeneca, Genentech, Amgen, and Daiichi Sankyo. Through the campaign, LUNGevity hopes to empower patients to request comprehensive biomarker testing at the time they are diagnosed with NSCLC, as well as when their cancer recurs or progresses. To accomplish this, the foundation will introduce patients to a "bill of rights" that lists the types of information they should understand and have access to with respect to biomarker testing and how the results of such testing can inform their treatment.
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.