Nuvation Cancels BET Inhibitor Program After Phase 1 Data Review

Nuvation Bio has decided to cease its work on the BD2-selective BET inhibitor NUV-868 after a thorough evaluation of phase 1 data. This decision stems from data on the drug's performance as both a monotherapy and in combination with other treatments, specifically AstraZeneca-Merck's Lynparza and Pfizer-Astellas' Xtandi. The phase 1b trial involving NUV-868 and Lynparza targeted patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple-negative breast cancer, and other solid tumors. The Xtandi combination was tested solely on mCRPC patients.

Currently, Nuvation's primary focus is advancing its ROS1 inhibitor taletrectinib towards FDA approval, with hopes of making it available to U.S. patients by 2025. CEO David Hung, M.D., highlighted this strategic move in the company's second-quarter earnings release, indicating that no phase 2 study of NUV-868 will be initiated for the solid tumor indications previously studied. However, Nuvation is considering future steps for NUV-868, potentially exploring its development in combination with approved products for certain indications where BD2-selective BET inhibitors might enhance patient outcomes.

NUV-868 gained prominence in Nuvation’s pipeline two years ago after the FDA imposed a partial hold on the company's CDK2/4/6 inhibitor NUV-422 due to unexplained eye inflammation cases. This led Nuvation to terminate the NUV-422 program, reduce its workforce by over a third, and reallocate its resources to NUV-868, as well as identify a lead clinical candidate from its innovative small-molecule drug-drug conjugate platform.

In recent developments, taletrectinib has become Nuvation’s top priority. The company is preparing for a possible release to patients next year, with data from the phase 2 TRUST-I and TRUST-II studies in non-small cell lung cancer (NSCLC) to be presented at the European Society for Medical Oncology Congress in September. This data will support Nuvation's planned FDA approval application for taletrectinib.

Nuvation concluded the second quarter with $577.2 million in cash and equivalents and recently completed the acquisition of AnHeart Therapeutics, a cancer-focused biotech. This acquisition aligns with Nuvation's strategic focus on bringing effective cancer therapies to market.

By prioritizing taletrectinib, Nuvation aims to address the needs of patients with ROS1-positive NSCLC, potentially offering a new treatment option. The company’s strategic decisions reflect a focused approach to pipeline development, ensuring resources are directed towards the most promising candidates.