Merkel cell provides Incyte’s laggard a way in

A few years ago the first approval of an anti-PD-(L)1 drug would have been trumpeted far and wide. But with seven already on the US market Incyte did not even disclose that it had filed the Macrogenics-originated retifanlimab, and the announcement yesterday that the drug had been approved as Zynyz for Merkel cell carcinoma thus came as a surprise. Investors received it with a shrug, presumably because Merkel cell is such an insignificant use. Still, this is not the point; Incyte needed retifanlimab to be approved not so it could have a monotherapy challenger but to give it an in-house PD-1 backbone for future combinations. The key lesson for laggards pursuing similar strategies is that Merkel cell – where only Merck & Co’s Keytruda and Merck KGaA/Pfizer’s Bavencio are approved, both through the accelerated pathway – remains a viable niche indication in which a quick nod is possible. Incyte had tried and failed to get retifanlimab greenlit in another peripheral use, squamous cell carcinoma of the anal canal, but a US adcom slammed its data in 2021, and a complete response letter followed.

Anti-PD-(L)1 laggards in the US
Project Company Lead indication(s) US status
Toripalimab Coherus/ Shanghai Junshi 1st-line chemo combo & 3rd-line monoRx nasopharyngeal carcinoma 2 May 2022 CRL; new Pdufa date 23 Dec 2022 missed because of Covid travel restrictions
Tislelizumab Novartis/ Beigene 2nd-line oesophageal squamous cell carcinoma 12 Jul 2022 Pdufa date missed because of Covid travel restrictions
Penpulimab Akeso/ Sino 3rd-line nasopharyngeal carcinoma 2022 Pdufa date missed, presumably because of Covid travel restrictions
Cosibelimab* Checkpoint (Fortress) Cutaneous squamous cell carcinoma 4 Jan 2024 Pdufa date, no adcom
Envafolimab* Tracon/ Alphamab/ 3D Medicines 1st-line biliary tract cancer (gemcitabine combo) Ph3 ends Jan 2024 (delayed from Dec 2021)
Serplulimab Shanghai Henlius/ Fosun 1st-line SCLC, vs Tecentriq Ph3 ends Jun 2024
Zimberelimab Arcus (via Wuxi/ Gloriabio) 1st-line PD-L1+ve NSCLC (+/- domvanalimab) Ph3 trial ends Feb 2024 (earlier Dec 2025)
Sasanlimab Pfizer Non-muscle-invasive bladder cancer (BCG combo) Ph3 ends Jun 2025 (delayed from Jun 2024)
Cetrelimab (JNJ-63723283) Johnson & Johnson Muscle-invasive bladder cancer (TAR-200 combo) Ph3 trial ends Dec 2026
Ezabenlimab (BI 754091) Boehringer Ingelheim Various, Lag3 & VEGF/Ang2 combos Ph2 trial ends May 2024
Balstilimab Agenus 2nd-line cervical cancer Filing pulled 22 Oct 2021
Sintilimab Innovent 1st-line non-squam NSCLC (Alimta combo) 24 Mar 2022 CRL
Sugemalimab* Cstone/ EQRX 1st-line NSCLC US filing plan abandoned
Spartalizumab Novartis Melanoma (Tafinlar+Mekinist combo) Failed Combi-I trial Aug 2020 (deprioritised)
Note: *anti-PD-L1; all others are anti-PD-1. Source: company disclosures &

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