Merck halts two Phase 3 Keytruda studies, including early-stage lung cancer trial

Merck announced on Thursday morning that it is halting two Phase 3 clinical trials of Keytruda, the world's leading medication in terms of sales, after independent data monitoring committees concluded that the trials were unlikely to be successful. These two trials, KEYNOTE-867 and KEYNOTE-630, represent a minor portion of the extensive clinical research landscape for Keytruda. Currently, the drug is involved in over 1,600 studies conducted by various pharmaceutical companies aiming to combine their treatments with this anti-PD-1 therapy, which generated $7 billion in sales during the second quarter.

Despite the large number of ongoing studies, this decision signifies a setback for efforts to expand the treatment to a broader range of patients, including those in earlier stages of non-small cell lung cancer (NSCLC). 

KEYNOTE-867 was evaluating the efficacy of Keytruda in combination with stereotactic body radiotherapy for stage 1 or 2 NSCLC (specifically stage 2B N0, M0). According to Merck, the combination did not demonstrate an improvement in event-free survival or in the critical secondary endpoint of overall survival during the planned interim analysis. The company had previously identified this trial as one of its major studies focusing on early stages of NSCLC.

On the other hand, KEYNOTE-630 was analyzing Keytruda as an adjuvant therapy for high-risk, locally advanced cutaneous squamous cell carcinoma following surgery and radiation. The data monitoring committee found that the risk-benefit profile was not compelling enough to continue the trial since the treatment did not meet the statistical significance threshold for recurrence-free survival. Additionally, the results did not favor Keytruda over a placebo in terms of the secondary endpoint of overall survival.

Merck, based in New Jersey, has garnered over 35 indications for Keytruda across more than 15 different tumor types and has invested over $45 billion in its development so far. CEO Rob Davis mentioned at a PhRMA event that the company anticipates allocating an additional $20 billion to Keytruda by 2030.

Keytruda is expected to lose its key market exclusivity in 2028. However, a subcutaneous formulation of the drug could potentially secure separate patent protection extending well beyond that period. Some companies are currently investigating biosimilars, while others are looking to finally pose a direct challenge to Keytruda's dominance.

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