Roche Streamlines Pipeline, Axes Multiple Chugai Assets in Strategic Review

Roche, the Swiss pharmaceutical giant, has announced a significant restructuring of its clinical pipeline, dropping five drug candidates from its Japanese subsidiary Chugai Pharmaceutical. This move, revealed in Roche's third-quarter results, reflects the company's ongoing efforts to optimize its drug development portfolio and maintain a high bar for advancement to later-stage trials.

Pipeline Pruning Targets Early-Stage Oncology Assets

The majority of the discontinued programs were early-stage oncology candidates, with four phase 1 solid tumor assets being removed from Roche's active pipeline. These include:

• Paluratide (LUNA18), a pan-RAS inhibitor
• STA551, a CD137-targeted antibody designed to mitigate liver toxicity
• SAIL66, an anti-CLDN6 trispecific antibody
• SOF10, an antibody targeting a tumor-specific TGF-β isoform

Roche CEO Thomas Schinecker emphasized that this decision does not signify a broader shift in the company's oncology strategy. Instead, it represents a continuation of Roche's rigorous evaluation process, where candidates must meet specific criteria to remain in development.

"As data comes in, data changes—it could be your own data, could be competitive data etc," Schinecker explained. "You constantly reassess the opportunity and likelihood of that molecule to be successful. So you constantly manage your portfolio that way."

Beyond Oncology: Endometriosis and Antibacterial Programs Affected

The pipeline restructuring extended beyond oncology, with Roche also discontinuing AMY109, a phase 2 anti-IL-8 antibody being developed for endometriosis. This long-acting antibody was designed to neutralize IL-8, a cytokine found to be highly upregulated in endometriotic tissues and correlated with disease progression.

Additionally, Roche halted development of RG6436, its own phase 1 LepB inhibitor intended to treat complicated urinary tract infections. This decision came after Roche had previously prioritized RG6436 over its first-generation candidate, RG6319, in its LepB program last year.

Chugai's Perspective and Future Plans

Chugai Pharmaceutical, which initially revealed the suspension of in-house development for these candidates in its second-quarter earnings report, provided additional context for some of the decisions. For instance, Chugai CEO Osamu Okuda noted that paluratide's narrower therapeutic window compared to competing products led to a shift in focus towards their KRAS inhibitor, AUBE00.

Despite the setbacks, Chugai remains committed to advancing its pipeline. Tsukasa Kusano, head of Chugai's project and life cycle management unit, highlighted some positive outcomes from the discontinued programs. For STA551, the company confirmed tolerability at higher dosage levels than typically achievable with standard CD137 antibodies, while also observing some level of efficacy.

Chugai plans to publish data on SAIL66, potentially providing valuable insights for future trispecific antibody development in oncology.