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Clinical Daily Summary

Clinical Daily Summary: What Happened on November 4, 2026

Servier’s sevasemten misses Phase 3 endpoint in Becker muscular dystrophy

Merck has started a Phase 3 COPD trial, while a Phase 2 lung cancer study found pathological responses with perioperative ivonescimab.

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Today in brief

In an 18-month trial, sevasemten did not improve physical function versus placebo in 175 adults with Becker muscular dystrophy.1 Servier is reviewing the results and has not said whether they will change its plans to study the drug in Duchenne muscular dystrophy.1

Merck has begun enrolling patients in a Phase 3 trial of Ohtuvayre to prevent chronic obstructive pulmonary disease (COPD) exacerbations.2 In a nonrandomized Phase 2 lung cancer trial, major pathological responses occurred with ivonescimab alone and with chemotherapy, but event-free survival data were immature.3

Sevasemten misses its primary endpoint in Becker muscular dystrophy

Sevasemten did not improve the primary North Star Ambulatory Assessment (NSAA) score versus placebo in GRAND CANYON, an 18-month trial of 175 adults with Becker muscular dystrophy.1 The trial also missed its secondary endpoints.1

Servier said sevasemten had a favorable safety and tolerability profile and that it is reviewing the broader results.1 The Phase 2 CANYON trial met its primary endpoint by reducing creatine kinase, a marker of muscle damage, but the NSAA difference versus placebo was not statistically significant.1

Servier completed its acquisition of Edgewise Therapeutics’ muscular dystrophy business on July 13, agreeing to pay $1.55 billion upfront and up to $1.1 billion in milestone payments.1 Servier has not said whether the Becker result will change its plans to study sevasemten in Duchenne muscular dystrophy.1

Merck starts Phase 3 test of Ohtuvayre for COPD exacerbations

Merck has started ENHANCE-3, a Phase 3 trial testing whether Ohtuvayre can prevent COPD exacerbations in adults receiving standard treatment.2 The trial has begun enrolling in the United States and plans to recruit about 2,136 people across 28 countries.2

Participants will be assigned equally to twice-daily Ohtuvayre or placebo, alongside their existing treatment.2 The primary outcome is the yearly rate of moderate or severe exacerbations over 52 weeks.2 The FDA approved Ohtuvayre for COPD maintenance treatment in June 2024.2

Phase 2 lung cancer study reports pathological responses with ivonescimab

In a nonrandomized Phase 2 trial of 90 people with resectable non-small cell lung cancer, 70.1% of patients who underwent surgery after ivonescimab plus chemotherapy had a major pathological response.3 The response rate was 60.0% among patients who underwent surgery after ivonescimab alone.3

Patients received ivonescimab before surgery and continued it afterward, with or without chemotherapy before surgery.3 Grade 3 or higher treatment-related adverse events occurred in 30.4% of the combination cohort and 36.4% of the monotherapy cohort.3 Investigators reported no grade 3 or higher hemorrhage or treatment-related deaths.3

Median event-free survival data were immature at the analysis cutoff.3

Also published