Immuno-oncology combinations and beyond

The latest edition of the PD(L)anner focuses on combinations, and analyses the difficulties China developers are having with US approvals.

Welcome to the fifth in a series of periodic Evaluate Vantage updates on PD-(L)1 inhibitor development, looking at recent clinical data and upcoming catalysts, with a particular focus this time on combinations.

Since last September combos have again taken centre stage, with only the second anti-CTLA-4 MAb approved in the US – Astrazeneca’s Imjudo, which got the nod a remarkable 11 and a half years after the first, Bristol Myers Squibb’s Yervoy. Padcev could soon be approved as part of a Keytruda combo, while Opdualag continues to make inroads into new markets.

A fourth combo partner, Tigit blockade, just about remains in play, and offers investors three clinical catalysts as 2023 gets under way. The latest PD(L)anner analyses these and other clinical, regulatory and commercial milestones, focusing specifically on inhibitors of PD-(L)1, and considering novel immuno-oncology mechanisms only when these are part of a combination with anti-PD-(L)1.

A recurring theme concerns the difficulties China-based developers are having in getting anything approved in the US; one group has stopped trying entirely, a second has seen a key deal canned, and three projects are held up amid inspection delays at the FDA.

However, Fosun is far from giving up, recently launching a bold clinical study head to head against Tecentriq. And China was also the source of one of the most extraordinary biotech deals of recent times, featuring the micro cap Summit, a $500m up-front fee and the former chief executive of Pharmacyclics.

Other moves analysed include the complex minefield for US prescribers that first-line NSCLC has become, and the growing focus on subcutaneously delivered PD-(L)1 drugs – a key theme as patent expiries loom. Numerous clinical trial successes and failures are discussed, with comparisons presented in summary tables.

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