Alkermes has expanded its ongoing Phase l clinical trial to examine the safety and anti-tumour activity of ALKS 4230 in combination with Keytruda (pembrolizumab) to treat patients with advanced solid tumours.

The trial comprises three stages, including an ongoing monotherapy dose-escalation stage, a proposed monotherapy dose-expansion stage and the newly started combination therapy stage of ALKS 4230 and pembrolizumab.

The trial’s dose-escalation stage intends to identify a maximum-tolerated dose of ALKS 4230 as a monotherapy and to determine the optimal dose range of ALKS 4230 based on immunological-pharmacodynamic effects.

Once this stage is concluded, the monotherapy dose-expansion stage is expected to begin in up to 42 patients with renal cell carcinoma or melanoma.

The combination therapy stage is expected to enrol up to 148 patients with select advanced solid tumours.

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It will be conducted independently and simultaneously with the trial’s monotherapy dose-escalation and dose-expansion stages.

“The potential synergies of ALKS 4230 and pembrolizumab on anti-tumour activity may expand treatment options for patients in a variety of tumour settings.”

Furthermore, the combination therapy stage will be evaluated in certain PD-1 approved tumour types in both refractory and treatment-naïve patients, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma, gastric cancer, and others.

Alkermes chief medical officer and Medicines Development and Medical Affairs senior vice-president Craig Hopkinson said: “The emergence of therapeutics targeting the PD-1 pathway has revolutionised the field of oncology, yet there remains significant opportunity to improve the clinical benefit of checkpoint inhibitors for the treatment of solid tumours.

“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-tumour activity may expand treatment options for patients in a variety of tumour settings.”

Alkermes plans to provide initial data from the dose-escalation cohorts later this year.