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Head and neck cancer up next for Jemperli

GSK’s choice of head and neck cancer as the next pivotal setting for Jemperli is brave. This cancer has proved tough for anti-PD-(L)1 drugs, but despite this a recently unveiled entry on reveals that the phase 3 Jade study will begin next month, comparing Jemperli against placebo in non-metastatic head and neck squamous cell carcinoma. Jemperli monotherapy is in pivotal development in just two other cancers – endometrial (its approved setting) and colon – while combinations with inhibitors of PARP, Tim-3 or TIGIT involve ovarian and lung cancers. Keytruda, Opdivo, Imfinzi and Bavencio have failed in eight key phase 3 trials in head and neck cancer, but a closer look at the design of Jade suggests some reason for optimism. This study will test Jemperli in an unusual setting, in patients eligible for surgery but whose tumours have yet to be resected, and who are still in response to chemoradiotherapy. It’s in this “curative intent” maintenance setting that Jemperli succeeded in a Memorial Sloan Kettering-sponsored trial in anal cancer, on the back of which GSK has begun the phase 2 Azur-1 and phase 3 Azur-2 colon cancer studies.


Phase 3 successes and failures in squamous head & neck cancer

Drug (company)StudySettingComment
Keytruda (Merck & Co)Keynote-0481LSupports monotherapy approval in 1L PD-L1≥1%
1LSupports chemo combo approval in 1L all-comers
Keynote-012UnspecifiedSupported accelerated approval for 2L (full approval after Keynote-048)
Keynote-0402LFailed vs standard treatment (2017)
Keynote-4121L & maintenanceChemo combo failed vs chemo (2022)
Leap-0101LLenvima combo failed vs Keytruda (2023)
Opdivo (Bristol Myers Squibb)Checkmate-1412L+Supports approval for 2L all-comers
Checkmate-7141LYervoy combo failed vs Opdivo (2019)
Checkmate-6511LYervoy combo failed vs Extreme regimen (2021)
Imfinzi (AstraZeneca)Eagle2LImjudo combo failed vs standard of care (2018)
Kestrel1LImjudo combo failed vs Extreme regimen (2021)
Bavencio (Merck KGaA)Javelin Head & Neck 1001LChemoradiotherapy combo failed vs chemoradiotherapy (2020)
Jemperli (GSK)JadeMaintenanceCurative intent study after chemoradiotherapy vs placebo, EFS primary (ends 2028)

Source: OncologyPipeline.


Molecular Drug Targets