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Mirati’s Adagrasib Challenger Fails To Differentiate Itself From Amgen’s Lumakras

 
• By Ayisha Sharma

While adagrasib showed decent efficacy in its pivotal study in NSCLC, some analysts said its inability to outperform Amgen’s Lumakras and its safety profile leave little room for differentiation.  

Adagrasib Must Stand Out From The Crowd If It Wants Market Success • Source: Shutterstock

Mirati Therapeutics, Inc.’s KRAS-inhibitor candidate adagrasib has succeeded in a registrational-enabling Phase II study in non-small cell lung cancer (NSCLC) but experts were skeptical about the drug’s potential to best Amgen, Inc.’s already marketed competitor, Lumakras (sotorasib).

The new data were released ahead of the American Society of Clinical Oncology meeting in Chicago next month from the Phase II cohort of the KRYSTAL-1 study in 116 NSCLC patients with a KRAS mutation, most of whom had received prior treatment with a PD-1/L1 inhibitor following or combined with chemotherapy. The drug candidate produced an objective response rate (ORR) of 43% with an 8

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Pipeline Watch: Six Approvals And Thirteen 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.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 
• By Andrew McConaghie

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

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Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
• By Joseph Haas

Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.