NEW YORK – Merck said this week that its anti-PD-1 therapy pembrolizumab (Keytruda) plus chemotherapy resulted in improved event-free survival among patients with high-risk, triple-negative breast cancer (TNBC) in the Phase III Keynote-522 study. Pembrolizumab plus chemotherapy as neoadjuvant treatment, followed by single-agent pembrolizumab as adjuvant treatment, improved patients' event-free survival versus neoadjuvant chemotherapy alone followed by adjuvant placebo. The trial was designed with two primary endpoints: event-free survival and pathological complete response. While Merck previously reported that the pembrolizumab-containing regimen improved pathological complete response, the US Food and Drug Administration issued a "complete response letter" in response to the company's supplemental biologics license application after its Oncologic Drugs Advisory Committee recommended a regulatory decision be deferred until further results from Keynote-522 are available. Now that those data are available, Merck hopes to "work with the FDA and other global authorities to bring this new option to patients as quickly as possible."
Caris Life Sciences said this week that the Sidney Kimmel Cancer Center has joined its Precision Oncology Alliance, a collaborative network of 50 leading cancer centers and academic institutions seeking to advance comprehensive cancer profiling and establish standards of care for molecular testing in oncology.
SKCC, one of 71 National Cancer Institute-designated cancer centers, serves oncology patients in the Greater Philadelphia region and is a leader in implementing advanced treatment methods and technologies. By joining Caris' POA, the center gains early access to the firm's extensive database and Molecular Intelligence platform, as well as to a network of precision medicine clinical trials and collaborative opportunities with other alliance members.
Seattle Cancer Care Alliance this week announced it is an authorized treatment center for Bristol Myers Squibb and Bluebird Bio's BCMA-targeted, autologous CAR T-cell therapy idecabtagene vicleucel (Abemca). Seattle Cancer Care Alliance is one of the first cancer centers in the US to offer idecabtagene vicleucel, or ide-cel, to patients. The US Food and Drug Administration approved ide-cel in March for heavily pretreated, refractory multiple myeloma patients.
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.