Eli Lilly entered two collaborations to study combination regimens for the treatment of cancer with anti-PD-1 therapies from Bristol-Myers Squibb and Merck & Co., the companies reported Tuesday. "Combination therapies will be key to addressing tumour heterogeneity and the inevitable resistance that is likely to develop to even the most promising new tailored therapies," remarked Richard Gaynor senior vice president of product development and medical affairs at Lilly Oncology.
In one Phase I/II trial, Eli Lilly will investigate its experimental TGF beta R1 kinase inhibitor galunisertib in combination with Bristol-Myers Squibb's Opdivo (nivolumab) in advanced glioblastoma, hepatocellular carcinoma and non-small-cell lung cancer (NSCLC). The companies noted that the collaboration will examine the hypothesis that co-inhibition of PD-1 and TGF beta negative signals may lead to enhanced antitumour immune responses versus inhibition of either pathway alone.
Eli Lilly will also conduct a Phase I/II trial assessing the investigational recombinant human IgG1 monoclonal antibody necitumumab together with Merck's Keytruda (pembrolizumab) in NSCLC. In addition, Eli Lilly will undertake a Phase I/II study examining Cyramza (ramucirumab) in combination with Keytruda in multiple tumours. Both studies are expected to begin this year. Further, Merck will conduct a Phase II study, which is currently enrolling patients, to investigate the combination of Keytruda and Eli Lilly's Alimta (pemetrexed) in first-line non-squamous NSCLC. Other terms of the collaborations were not disclosed.
Keytruda became the first FDA-approved PD-1 inhibitor following its clearance last year for advanced or unresectable melanoma, with Merck recently disclosing plans to seek expanded approval of the therapy for the treatment of patients with EGFR mutation-negative and ALK rearrangement-negative NSCLC. For related analysis, see ViewPoints: Could Merck & Co. deliver another stealthy US approval for Keytruda – this time in NSCLC?
Meanwhile, Opdivo was granted accelerated approval by the US regulator for the treatment of patients with unresectable or metastatic melanoma who no longer respond to other drugs. Bristol-Myers Squibb said Monday that a Phase III trial of the agent versus docetaxel in previously treated patients with advanced, squamous cell NSCLC was stopped early after meeting its endpoint (for related analysis, read ViewPoints: Bristol-Myers Squibb passes through key Opdivo checkpoint with Merck & Co. hot on its heels).
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