Clinical showdown in immuno-oncology

Welcome to the fourth in a series of periodic Evaluate Vantage updates on PD-(L)1 inhibitor development, whose main focus is on recent clinical data and upcoming catalysts.

Since March the checkpoint inhibitor space has witnessed clinical readouts galore. But, while China approved the world’s first anti-PD-1xCLTA-4 bispecific, in the west the stranglehold of the established players, led by Merck & Co’s Keytruda, continues, the latest edition of Vantage’s PD(L)anner reports.

True, in the approval of Bristol’s Opdualag the US welcomed a brand new immuno-oncology mechanism, but as for follow-on PD-(L)1 inhibitors, all attempts to get to the market have so far landed on stony ground. Failures to secure US regulatory green lights for Incyte/Macrogenics’ retifanlimab and Agenus’s balstilimab have been followed by a widely expected complete response letter for Innovent/Lilly’s sintilimab.

A separate CRL was handed to Coherus/Shanghai Junshi’s toripalimab, Cstone/EQRX gave up – for now – trying to gain approval for sugemalimab, and Pdufa action deadlines were missed for Novartis/Beigene’s tislelizumab and Akeso/Sino’s penpulimab.

As before, this report focuses specifically on inhibitors of PD-(L)1, and considers novel immuno-oncology mechanisms only when these are part of a combination with anti-PD-(L)1. It details further clinical and regulatory catalysts, with comprehensive tables, and developments in April-August, including:

• A look at how follow-on PD-(L)1 inhibitor go-to-market strategies have landed so far.
• Insights on upcoming catalysts including a regulatory decision on Astrazeneca’s tremelimumab.
• News on one success and one failure for new immuno-oncology mechanisms.
• Developments in licensing and strategies for mitigating looming patent expiries.
• A summary of all the recent approvals in the US, EU, China and Japan.

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