Irish biopharma company Alkermes said that it has expanded an ongoing phase 1 trial for its immuno oncology drug ALKS 4230 to assess its safety and anti-tumor activity in combination with Merck’s PD-1 inhibitor KEYTRUDA (pembrolizumab) in advanced solid tumors.
According to Alkermes, ALKS 4230 is an engineered fusion protein which selectively binds and signals via the intermediate affinity interleukin-2 (IL-2) receptor complex. As a result of this function, the immune oncology drug preferentially activates and increases the number of immunostimulatory tumor-killing immune cells while avoiding the growth of immunosuppressive cells that interfere with anti-tumor response.
The FDA-approved pembrolizumab, on the other hand, increases the ability of the immune system to help in detection and fighting against tumor cells.
The combination of ALKS 4230 and pembrolizumab will be evaluated in certain PD-1 approved tumor types in both refractory and treatment naïve patients. Included in these are non-small cell lung cancer (NSCLC), gastric cancer, head and neck squamous cell carcinoma, microsatellite instability-high cancers and urothelial carcinoma.
The Irish biopharma company also plans to evaluate the combo for melanoma and renal cell carcinoma in the cohort of patients who previously didn’t undergo any treatment for their condition.
Alkermes says that the ALKS 4230 and pembrolizumab combo will also be evaluated in certain PD-1 unapproved tumor types such as colorectal cancer, triple-negative breast cancer, soft tissue sarcomas, ovarian carcinoma, and 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, said: “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, and the potential synergies of ALKS 4230 and pembrolizumab on anti-tumor activity may expand treatment options for patients in a variety of tumor settings.”