Pfizer has agreed to evaluate the combination of its lung cancer drug crizotinib (Xalkori) with Merck’s investigational anti-PD-1 antibody pembrolizumab, in a Phase Ib clinical trial to treat patients with ALK-positive advanced or metastatic non-small cell lung cancer (NSCLC).

The multi-centre, open-label clinical trial will evaluate the safety and tolerability of the combination therapy, and is scheduled to be initiated in 2015 by Pfizer.

Xalkori is a kinase inhibitor indicated to treat patients with metastatic NSCLC whose tumours are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test, while pembrolizumab is designed to reactivate anti-tumour immunity.

Pfizer Oncology Clinical Development and Medical Affairs senior vice-president Dr Mace Rothenberg said: "This collaboration between Pfizer and Merck is just one example of the willingness of sponsors to work together in an effort to accelerate progress against some of the most difficult-to-treat cancers.

"The multi-centre, open-label clinical trial will evaluate the safety and tolerability of the combination therapy."

"Understanding the effects of combining one drug, Xalkori, which inhibits an abnormally activated enzyme in patients with ALK-positive metastatic lung cancer, with the investigational drug, pembrolizumab, which harnesses the body’s immune system to fight cancer, is vital if we are to continue to advance the care of lung cancer patients."

Merck Research Laboratories Oncology vice-president Eric Rubin said: "We are pleased to build upon our ongoing collaboration with Pfizer to evaluate potential combination regimens incorporating Merck’s investigational immunotherapy pembrolizumab.

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"Evidence from early studies of pembrolizumab monotherapy together with Xalkori’s proven targeted therapeutic approach provides the scientific rationale for evaluating this combination for the treatment of lung cancer."

Merck is also evaluating pembrolizumab in combination with Pfizer’s Inlyta (axitinib) for the treatment of renal cell carcinoma, and with an experimental drug PF-2566 that Pfizer is evaluating in several cancer types.

According to the companies, patient enrolment in these trials is scheduled to start later this year.

Image: Micrograph of a squamous carcinoma, a type of non-small-cell lung carcinoma. Photo: courtesy of Nephron.