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Amgen’s KRAS Inhibitor Shows Durability; Pivotal Data Possible This Year

Ongoing Phase II Study Could Support Accelerated Approval

 
• By Mandy Jackson

Newly published data and results presented at ESMO for Amgen’s sotorasib (AMG 510) show relatively long-lasting responses and progression-free survival in lung cancer. 

White lung cancer awareness ribbon and lung symbol on red background. November lung cancer awareness month. Healthcare and medicine concept.
To date, sotorasib monotherapy works best in lung cancer • Source: Shutterstock

Amgen, Inc. is moving its closely watched KRAS inhibitor sotorasib (AMG 510) forward at an aggressive pace with plans to seek accelerated approval based on a single-arm Phase II monotherapy trial in non-small cell lung cancer (NSCLC) if the results are consistent with new Phase I data published in the New England Journal of Medicine and presented at the European Society of Medical Oncology (ESMO) Virtual Congress.

The NEJM publication and ESMO presentation on 20 September showed a confirmed overall response (ORR) rate of 35.3% (all partial...

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

 
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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.