Novartis and BMS collaborate on lung cancer immunotherapy

Novartis and Bristol-Myers Squibb have made a move to collaborate in one of the hottest areas in pharma today: immunotherapy treatments for non-small cell lung cancer (NSCLC).

Lung cancer is the most common cancer worldwide, and the biggest killer and immunotherapy is promising breakthroughs in treating a wide range of cancers.

Novartis and Bristol-Myers Squibb have unveiled what they call a ‘clinical collaboration’ to investigate the safety, tolerability and preliminary efficacy of three molecularly targeted compounds in combination with Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, Opdivo (nivolumab).

The PD-1 and PD-L1 checkpoint inhibitors are among the hottest properties in the pharma industry at the moment, and work by awakening the body’s own immune system to help fight cancer.

Opdivo and its closest rival, Merck’s Keytruda (pembrolizumab) have gained their first approvals in skin cancer melanoma, but the greatest unmet medical need is in NSCLC – and equally the most lucrative market.

It is also acknowledged that the new immunotherapy drugs are likely to help extend lives further when used in combination with other drugs.

Analysts predict that any immunotherapy which can significantly extend overall survival in NSCLC is guaranteed multi-billion dollar sales.

For that reason, Novartis and BMS have seized the opportunity to combine their treatments in two new phase I/II trials see which might yield the best results in NSCLC, a tumour that has proven resistant to many different treatments.  The move is particularly important for Novartis, as it is not among the frontrunners in cancer immunotherapy, and doesn’t want to be left behind, particularly as oncology is one of its core therapy areas.

Both studies will be conducted by Novartis: one trial will evaluate the combination of Opdivo with Zykadia (ceritinib), Novartis’ drug for ALK+ metastatic NSCLC patients who have progressed on or are intolerant to crizotinib.

The second study will investigate Opdivo with INC280, a potent and highly selective inhibitor of c-MET receptor tyrosine kinase, and separately with EGF816, a potent, third-generation EGFR tyrosine kinase inhibitor that is active against T790 mutations.

INC280 and EGF816 are currently being investigated in various Phase I/II NSCLC trials. Additional details of the collaboration were not disclosed.

“Preclinical data suggests that combining molecularly targeted agents with immunotherapies such as nivolumab may have synergistic effects and lead to better outcomes for patients,” said Alessandro Riva, MD, global head, Novartis Oncology Development and Medical Affairs.

“This collaboration enables us to study several key compounds, including our new highly-potent ALK inhibitor Zykadia, together with a promising, novel immunotherapy agent, paving the way for potential new treatment approaches for patients with NSCLC.”

Opdivo has already been filed in Europe for use in NSCLC, the company announcing that the EMA has accepted its submission last week.

BMS has begun a rolling submission with the FDA for Opdivo in third-line pre-treated squamous cell NSCLC and expects to complete the submission by year-end.

One of the main competitors in the NSCLC field is likely to be AstraZeneca, whose immunotherapy MEDI4736 entered phase III trials in May. AstraZeneca and its biologics division MedImmune have begun a wide array of combination trials of its drug, including combinations with a number of its own immunotherapy drugs with different mechanisms.

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