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Lilly's Lartruvo/chemo combo surprises with Phase 3 failure in soft tissue carcinoma

Published on 21/01/19 at 11:39am

Eli Lilly has reluctantly pulled back the curtain on new Phase 3 data for its platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody Lartruvo (olaratumab), revealing that the therapy failed to present clinical benefit in the treatment of advanced or metastatic soft tissue sarcoma (STS) when used in combination with standard of care chemotherapy drug doxorubicin, compared to doxorubicin alone.

The ANNOUNCE study sought to determine the overall survival (OS) benefit of the combination – it’s primary endpoint.  However, no such benefit could be confirmed, either in the full study population or in the leiomyosarcoma (LMS) sub-population, with no survival difference observed between the study arms for either group.

However, the company was keen to point out that despite this underperformance, the combo was well tolerated in both study arms, with no new safety signals reported.

"Lilly was surprised and disappointed that Lartruvo did not improve survival for patients with advanced soft tissue sarcoma in this study," remarked Anne White, President of Lilly Oncology. "Lilly is committed to helping people who have soft tissue sarcoma and we will carefully study the detailed data in an effort to better understand the different results between the two trials.”

The findings are somewhat contrary to those of the previous Phase 2 trial, where the combo displayed OS benefit in 133 STS patients, leading to an accelerated approval from the FDA and conditional approval by the EMA. As continued approval relies on confirmation of the combo’s clinical benefit, Lilly is currently in discussion with global regulators to determine what is now required, during which time patients already receiving Lartruvo may continue in consultation with their physician if they are seeing benefit.  

Lilly plans to present the full data derived from the study at an upcoming medical meeting.

Matt Fellows

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