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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 responses) and disease control rate (DCR) of 91

Sotorasib In NSCLC

The first Phase I cohort of CodeBreaK 100 enrolled 129 patients for treatment with four different doses of sotorasib, including 59 NSCLC patients, all of whom received at least one prior round of chemotherapy; 90% had also been treated with a PD-1/PD-L1 inhibitor.

The ORR in NSCLC across all dose levels was 32.2% and the DCR was 88.1% with a 10.9-month median duration of response at the 1 June data cutoff; 10 of the 19 responders remained in response

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In Brief: Strong OS Results For Immutep’s Eftilagimod/Keytruda Combo In Head And Neck Cancer

 
• By Sushmita Panda

Australian firm's combo of eftilagimod and Keytruda shows 17.6-month median overall survival in first-line HNSCC patients with low PD-L1, raising hopes for potential accelerated approval.

In Brief: Positive New Data For Aptose’s Triplet Therapy In 1L AML

 
• By Sushmita Panda

Aptose’s tuspetinib triplet shows early mutation-agnostic promise in new data from Phase I/II program for frontline acute myeloid leukemia.

Chinese Firms Build Obesity Clinical Pipeline But Face Wider Hurdles

 
• By Xu Hu

Despite the ability to initiate clinical trials quickly and having strong manufacturing capacity, Chinese companies are facing multiple challenges in the obesity space.

Aldeyra Plans To File Reproxalap Again With New Dry Eye Symptom Data

 
• By Joseph Haas

The biotech hopes a third time will be the charm after two FDA complete responses, with plans to position its eye drop as offering quicker onset of action.

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Lilly And Alchemab Tap Into Resilient Individuals To Develop ALS Drug

 
• By Andrew McConaghie

The pharma company is helping to validate the biotech’s model by developing a novel amyotrophic lateral sclerosis candidate, based on its novel approach that ‘turns drug discovery on its head’.

Pipeline Watch: Thirteen Approvals And Ten 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.

Accelerated Approval May Be Out Of Reach For PTC’s Huntington’s Drug

 
• By Joseph Haas

PTC said its updated Phase II data for PTC 518 met the primary endpoint of Huntingtin’s protein reduction, but analysts said there isn’t clear correlation with clinical benefit.