4:54 PM
May 16, 2018
 |  BC Extra  |  Clinical News

Merck, Pfizer report early data for PD-L1/ALK inhibitor combos

Merck KGaA (Xetra:MRK) and Pfizer Inc. (NYSE:PFE) reported data from the Phase Ib/II JAVELIN Lung 101 trial evaluating the partners' PD-L1 inhibitor Bavencio avelumab in combination with Pfizer's anaplastic lymphoma kinase inhibitors to treat previously treated advanced non-small cell lung cancer (NSCLC). The data were released late Wednesday in an abstract ahead of the American Society of Clinical Oncology meeting in Chicago.

In the Phase Ib portion of the trial, 12 ALK-negative patients received Bavencio plus Xalkori crizotinib and 28 ALK-positive patients received Bavencio plus lorlatinib (PF-06463922). All ALK-negative patients received prior anticancer therapy and ALK-positive patients received a median of two prior ALK tyrosine kinase inhibitors (TKIs).

Bavencio plus Xalkori led to a confirmed objective response rate (ORR) of 16.7%, including two partial responses (PRs), compared with an ORR of 46.4% for Bavencio plus lorlatinib, including one complete response (CR) and 12 PRs.

A planned Phase II trial will evaluate Bavencio plus lorlatinib in treatment-naïve ALK-positive NSCLC patients.

Xalkori is a a dual inhibitor of c-Met receptor tyrosine kinase (c-MET; MET; HGFR; c-Met proto-oncogene) and ALK and their oncogenic variants, and lorlatinib is an inhibitor of ALK and c-ros proto-oncogene 1 receptor tyrosine kinase (ROS1).

Last year, Bristol-Myers Squibb Co. (NYSE:BMY) and Novartis AG (NYSE:NVS; SIX:NOVN) reported data from a Phase I trial of BMS's anti-PD-1 mAb Opdivo nivolumab in combination with Novartis' oral ALK inhibitor Zykadia ceritinib to treat ALK-positive advanced NSCLC. In 20 patients who previously received an ALK inhibitor, Opdivo plus Zykadia led to an ORR of 45%, including nine PRs. In 16 ALK inhibitor-naïve patients, Opdivo plus Zykadia led to an ORR of 75%, including one CR and 11 PRs.

Bavencio has accelerated approval for Merkel cell carcinoma (MCC) and metastatic urothelial carcinoma in the U.S. and conditional approval for MCC in the EU. Merck and Pfizer share rights to the drug under a 2014 deal.

Lorlatinib is under review in the U.S., EU and Japan to treat NSCLC. The NDA is under FDA Priority Review with an August PDUFA date.

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