Alkermes expands Phase 1 trial of ALKS 4230 in combination with KEYTRUDA for advanced solid tumors

Irish biopharmaceutical company Alkermes has announced an expansion of its ongoing Phase 1 trial to evaluate the safety and anti-tumor activity of its immuno-oncology drug ALKS 4230 in combination with Merck’s PD-1 inhibitor KEYTRUDA (pembrolizumab). This trial aims to explore the potential of this combination therapy in treating advanced solid tumors.

ALKS 4230 is an engineered fusion protein that selectively binds and signals through the intermediate affinity interleukin-2 (IL-2) receptor complex. This unique mechanism allows the drug to preferentially activate and increase the population of immunostimulatory tumor-killing immune cells, while minimizing the growth of immunosuppressive cells that can hinder the anti-tumor response.

Pembrolizumab, marketed under the brand name KEYTRUDA, enhances the immune system’s ability to detect and combat tumor cells. This FDA-approved drug is pivotal in increasing immune surveillance against cancer.

The combined therapy of ALKS 4230 and pembrolizumab will be assessed across various PD-1 approved tumor types, including non-small cell lung cancer (NSCLC), gastric cancer, head and neck squamous cell carcinoma, microsatellite instability-high cancers, and urothelial carcinoma. The trial will include both refractory patients and those who have not received prior treatment.

In addition to the types mentioned above, Alkermes plans to test the drug combination in patients with melanoma and renal cell carcinoma who have not previously been treated. The company also intends to explore its efficacy in PD-1 unapproved tumor types such as colorectal cancer, triple-negative breast cancer, soft tissue sarcomas, ovarian carcinoma, and in patients with metastatic NSCLC whose tumors express low or undetectable PD-L1.

Craig Hopkinson, Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes, expressed optimism about the combination’s potential. “There is strong scientific rationale supporting the combination of PD-1 pathway inhibition with cytokine therapy such as ALKS 4230 to activate the body’s own immune system to fight cancer. The potential synergies of ALKS 4230 and pembrolizumab on anti-tumor activity may expand treatment options for patients in a variety of tumor settings,” said Hopkinson.

The expansion of this Phase 1 trial by Alkermes signifies a pivotal step in cancer treatment research, aiming to harness and enhance the body’s natural immune responses against tumors. As the study progresses, it may pave the way for new, more effective cancer therapies that can be tailored to individual patient needs.