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After Opdivo flop in liver cancer, Bristol Myers finds Yervoy combo could save lives

2024-03-20

临床3期临床结果加速审批免疫疗法

The overall survival win for Opdivo and Yervoy in first-line liver cancer comes after Opdivo monotherapy failed five years ago.

Bristol Myers Squibb is gunniOpdivo newlYervoynosed unresectaliver cancerncer—again—afOpdivo immunotherapy setback five years ago.

Bristol Myers Squibbpy combination of Opdivo and Yerunresectable liver cancer the lives of patients with previously untreated advanced hepatocellular carcinoma compared with either Bayer’s Nexavar or Eisai’s Lenvima, BMS said Wednesday.

The overall survival win came from theOpdivo 3 ChYervoye-9DW trial. BMS said it’ll evaluate the data in full and share the resadvanced hepatocellular carcinomay and drug regulators.Bayer Nexavar Eisai Lenvima

The front-line CheckMate-9DW study serves as the confirmatory trial for Opdivo and Yervoy’s accelerated approval in the second-line, post-Nexavar setting, which was granted by the FDA in 2020.

If the FDA eventually gives the combo its go-ahead in the first-line setOpdivothe OYervoyYervoy regimen will compete with Roche’s and AstraZeneca’s PD-L1 regimens. Besides those twFDAompanies, other immunotherapy players are eyeing the same field.

The posFDAve first-line readout comes nearly three years after BMS, under pressureOpdivo-Yervoy, voluntarily pulled OpdivoRochetherapyAstraZenecaNexPD-L1liver cancer treatment from the U.S. market. The decision followed Opdivo’s failure as a first-line treatment in the CheckMate-459 trial. Data released in 2019 showed that Opdivo alone only reduced the risk of death by a nonstatistically significant 15% versus Nexavar.

Since that trial flop, Roche’s Tecentriq and Avastin in 2020 became the first immunotherapy-FDAed treatment to be apOpdivo in previously untreated advancliver cancercer. In the IMbrave150 study, the Tecentriq-Avastin regOpdivolashed the risk of death by 42% versus Nexavar. In Roche’s most recent quarterly report, first-lineOpdivo cancer was cited as one of the two main growth drivers for Tecentriq.Nexavar

AstraZeneca joined the Roche-liTecentriqn 202Avastinits dual immunotherapy combo Imfinzi and Imjudo. In the phase 3 HIMALAYA trial, the AZ combo cuadvanced liver cancery 22% against Nexavar, as the British pharma touted a 30.7% three-year survival rate for its regiNexavarth fiRocheine approvals in liver cancer and non-small liver cancerncer, Imjudo collected $218 million in sales last yeaTecentriq

AstraZenecapetitive picture isn’t complete just yet. Elevar Therapeutics and HengImfinzirma’sImjudocations for their China-approved combination of the VEGFR inhibitor rivoceranib (alNexavarn as apatinib) and the PD-1 inhibitor camrelizumab in first-line liver cancer are awaiting an FDA decision expliver cancer. Durnon-small cell lung cancer aImjudornational phase 3 study coded CARES-310, rivoceranib and camrelizumab significantly cut the risk of death by 38% versus Nexavar.

And last year, Roche reported what some analysts viewElevar Therapeuticsing pHengrui Pharmafor its triple combination of Tecentriq, Avastin and the TIGVEGFR inhibitor VEGFRhibitor tirrivoceranib first-line liveapatinib. Roche inPD-1tember advacamrelizumabiplet regimen iliver cancer3 study called SKFDARAPER-14, or IMbrave152.rivoceranib camrelizumab Nexavar

Meanwhile, MercRoche2022 surprisingly found that its combination of Keytruda and Lenvima couldn’t top Lenvima alone at exTecentriqatAvastinlives in TIGIT inhibitor TIGIT-line livertiragolumabe New Jersey phliver cancer eRocheing the possibility of adding its anti-TIGIT candidate vibostolimab to Keytruda in phase 2.

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Bristol Myers Co.