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Head and neck cancer up next for Jemperli
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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 clinicaltrials.gov 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) | Study | Setting | Comment |
---|---|---|---|
Keytruda (Merck & Co) | Keynote-048 | 1L | Supports monotherapy approval in 1L PD-L1≥1% |
1L | Supports chemo combo approval in 1L all-comers | ||
Keynote-012 | Unspecified | Supported accelerated approval for 2L (full approval after Keynote-048) | |
Keynote-040 | 2L | Failed vs standard treatment (2017) | |
Keynote-412 | 1L & maintenance | Chemo combo failed vs chemo (2022) | |
Leap-010 | 1L | Lenvima combo failed vs Keytruda (2023) | |
Opdivo (Bristol Myers Squibb) | Checkmate-141 | 2L+ | Supports approval for 2L all-comers |
Checkmate-714 | 1L | Yervoy combo failed vs Opdivo (2019) | |
Checkmate-651 | 1L | Yervoy combo failed vs Extreme regimen (2021) | |
Imfinzi (AstraZeneca) | Eagle | 2L | Imjudo combo failed vs standard of care (2018) |
Kestrel | 1L | Imjudo combo failed vs Extreme regimen (2021) | |
Bavencio (Merck KGaA) | Javelin Head & Neck 100 | 1L | Chemoradiotherapy combo failed vs chemoradiotherapy (2020) |
Jemperli (GSK) | Jade | Maintenance | Curative intent study after chemoradiotherapy vs placebo, EFS primary (ends 2028) |
Source: OncologyPipeline.
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