Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has announced encouraging early outcomes from its Phase 1/2 clinical trial, which evaluates a new immunotherapy combination of REGN7075 and Libtayo (cemiplimab) targeting advanced solid tumors. This trial is among the first to show effectiveness in patients with microsatellite stable colorectal cancer (MSS CRC), a type traditionally resistant to immunotherapies.

Dr. Neil H. Segal, Medical Oncologist and Research Director in the Division of Gastrointestinal Oncology at Memorial Sloan Kettering Cancer Center, expressed optimism about the results. “We are seeing promising anti-tumor responses with this novel investigational EGFRxCD28 costimulatory bispecific combined with Libtayo in treating microsatellite stable colorectal cancer, a notoriously difficult cancer type to manage,” stated Dr. Segal.

Key Findings from the Ongoing Clinical Trial

During the trial’s dose-escalation stage, 94 patients with various advanced solid tumors received the combination treatment after an initial dose of REGN7075 alone. Out of these, 65% had MSS CRC. From this subgroup, the data showed an overall response rate of 6% and a disease control rate of 29%, including one complete response, two partial responses, and stable disease in 12 patients.

Assessing Safety and Expanding the Trial

The safety assessment involved 84 patients, revealing that the treatment was generally well-tolerated. The most common side effects were infusion-related reactions, which were manageable with standard premedication and dosing adjustments. The trial continues to explore the effectiveness of the treatment in additional solid tumors, including lung and head and neck cancers.

The Future of Regeneron’s Oncology Innovations

Regeneron’s approach involves using costimulatory bispecifics to potentially transform immunologically ‘cold’ tumors into ‘hot’ ones, making them more responsive to treatment. “Our focus on developing a robust portfolio of oncology treatments is showing promise, particularly with our costimulatory bispecifics, which could play a crucial role in managing hard-to-treat cancers,” commented Dr. Israel Lowy, Senior Vice President of Translational and Clinical Oncology at Regeneron.

The continuing research and development of REGN7075 in combination with Libtayo are set to potentially redefine treatment paradigms across several types of solid tumors.

  Advanced solid tumors, Colorectal cancer, immunotherapy research, Libtayo, Phase 1/2 clinical trial, Regeneron Pharmaceuticals, REGN7075