Servier Phase III colorectal cancer trial fails to meet primary endpoint

pharmafile | October 22, 2021 | News story | Medical Communications  

Global independent pharmaceutical group, Servier, has announced that the primary objective (progression free survival) of the Phase III SOLSTICE trial has not been met.

SOLSTICE was designed to evaluate the efficacy of LONSURF® (trifluridine/tipiracil) + bevacizumab, against capecitabine and bevacizumab, in first line unresectable metastatic colorectal cancer (mCRC) patients non-eligible for intensive therapy.

Despite this, the study will continue as planned, as no severe safety issues have been raised.

Nearly 1.4 million people are diagnosed with colorectal cancer (CRC) each year worldwide, equating to 10% of the global cancer cases. In Europe, CRC is the second most common cause of cancer death, and metastatic patients have a low 5-year survival rate of 11%. This increases the need for new treatments, as standard chemotherapy regimens may not be effective for all patients.

“We remain committed to improving outcomes in mCRC and we will continue to follow patients as planned in order to perform the main secondary endpoint analysis on overall survival in 2023,” said Patrich Therasse, MD, PhD, Head of Late Stage and Life Cycle Management, and Deputy Head Oncology and Immuno-Oncology Therapeutic Area, Servier.

“The clinical value of LONSURF in its current indications remains unchanged, and the ongoing Phase III SUNLIGHT trial (Lonsurf and bevacizumab versus LONSURF in 3rd line mCRC) is proceeding as planned.”

“Metastatic colorectal cancer patietns who are not well enogh to undergo intensive chemotherapy have limited options, and quality of life is a priority,” said Professor Thierry Andre, MD, Saint Antoine Hospital, Paris, France, and Lead investigator for the SOLSTICE study. “We are continuously searching for new ways to give these patietns efficient treatment with low toxicities.”

Lina Adams

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