NEW YORK – Merck said this week that the US Food and Drug Administration has accepted its new supplemental biologics application for pembrolizumab (Keytruda) as a treatment for advanced, previously treated endometrial cancer patients with high microsatellite instability (MSI) or mismatch repair deficient (dMMR) tumors. The FDA is expected to make a decision on the application by March 28, 2022, based on results from cohorts D and K of Merck's Keynote-158 basket trial. Merck will present data from the D and K cohorts — which involved advanced endometrial cancer patients and tumor-agnostic MSI-high cancer patients, respectively — during an upcoming medical conference.
Tango Therapeutics this week combined with BCTG Acquisition, a special purpose acquisition company, and began trading on the Nasdaq Capital Market under the symbol "TNGX." In the deal, announced in April, Tango received $342 million from BCTG's trust account and $186 million from a private investment in public equity financing round. The combined company, which will continue to be led by Tango's current CEO Barbara Weber, will use the raised funds to advance TNG908, an MTA-cooperative PRMT5 inhibitor, along with earlier stage products including a USP1 inhibitor and an undisclosed target.
Lantern Pharma this week said that the US Food and Drug Administration has granted its next-generation DNA-damaging alkylating agent LP-184 orphan drug designation for the treatment of pancreatic cancer. LP-184 damages DNA in cancer cells that harbor genetic mutations or that overexpress certain biomarkers. In preclinical studies, LP-184 shrunk pancreatic tumors by more than 90 percent in mice, while tumors in untreated mice grew elevenfold in volume. With orphan drug designation, Lantern will have seven additional years of market exclusivity for LP-184 if it garners FDA approval and is commercialized as a pancreatic cancer treatment.
Turning Point Therapeutics' ROS1 inhibitor repotrectinib received fast track designation from the US Food and Drug Administration this week. The agency granted repotrectinib the designation as a treatment for ROS1-positive, advanced non-small cell lung cancer patients who have previously received one other ROS1 inhibitor but no prior platinum-based chemotherapy. In Phase II data presented last year, repotrectinib showed an objective response rate of 67 percent in a small cohort of these patients.
Autolus Therapeutics said this week that the UK Medicines and Healthcare products Regulatory Agency has granted promising innovative medicine, or PIM, designation to Autolus' Car T-cell therapy obecabtagene autoleucel for patients with relapsed or refractory B-cell acute lymphocytic leukemia. Autolus is currently investigating the autologous treatment, also called obe-cel or AUTO1, in a Phase Ib/II clinical trial dubbed FELIX. The MHRA grants PIM designation to drugs that can potentially benefit patients with a high unmet need. With this designation, obe-cel is now a candidate for MHRA's early access to medicines scheme.
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.