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An Early Surprise Win For BMS’s Opdivo/Yervoy In Lung Cancer

 
• By Mary Jo Laffler

CheckMate-9LA testing nivolumab plus ipilimumab plus chemo was stopped early due to a survival win. The promise of another foothold in first-line lung cancer could buoy investors ahead of what could be disappointing Q3 sales.

Digital illustration of lung cancer cells in color background

Bristol-Myers Squibb Co. should be able to forestall some investor concerns about lagging sales of its one-time leading PD-1 inhibitor Opdivo when third quarter results are released on 31 October with the surprise announcement 22 October of an important win in the critical first-line lung cancer setting for the combination of Opdivo plus Bristol’s CTLA-4 inhibitor Yervoy and chemotherapy.

It’s an oddly similar dynamic to the previous quarter, when positive results from the Phase III CheckMate-227 trial came out...

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Another Day Another Win For Novartis’s Ianalumab – This Time In ITP

 
• By Aakash Babu

The Swiss drugmaker’s BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate has chalked up another win in late-stage development, further strengthening its pipeline-in-a-product bid.

Pfizer/Astellas’s Padcev Scores First Big Win In Bladder Cancer Study

 
• By Alaric DeArment

The drug, combined with Merck’s Keytruda, was successful among certain chemotherapy-ineligible MIBC patients, with another Phase III readout expected by March 2026.

IO Biotech Plans Cylembio Filing Despite ‘Narrowly Missed’ Phase III Endpoint

 
• By Mandy Jackson

The company plans to meet with the US FDA prior to submitting a BLA before the end of 2025 for its cancer vaccine as a first-line advanced melanoma treatment in combination with Keytruda.

Sjögren’s Success For Ianalumab Shores Up Novartis’s Pipeline-In-A-Product Plans

 
• By Alexandra Shimmings

Novartis has strengthened its argument that ianalumab, its BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate, has PIP potential with successful topline results in two Phase III Sjögren’s syndrome trials, after recently dropping the product in hidradenitis suppurativa.

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Pipeline Watch: Five Approvals And Two Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Genmab/AbbVie’s Epkinly Likely To See Label Expansion After Phase III Win

 
• By Alaric DeArment

The FDA is expected to rule on the anti-CD20xCD3 bispecific combined with rituximab/lenalidomide in second-line follicular lymphoma in November.

Novartis’s ‘Pipeline-In-A-Product’ Assets Progressing Well

 
• By Kevin Grogan

CMO Shreeram Aradhye talks to Scrip about the promise shown by ianalumab, remibrutinib and a next-generation CAR-T for immunological disorders.