Dr Reddy's Partner Immutep Halts Phase III Trial of Eftilagimod Alfa in Lung Cancer Study
New Delhi: Dr. Reddy's Laboratories Limited has informed stock exchanges that the Phase III clinical trial evaluating the drug candidate Eftilagimod Alfa for first-line non-small cell lung cancer has been recommended for discontinuation following an interim analysis.
The development relates to a strategic collaboration and exclusive licensing agreement between Dr. Reddy’s Laboratories SA, a wholly owned subsidiary of Dr. Reddy’s Laboratories Limited, and Immutep SAS, a subsidiary of Immutep Limited. Under the agreement announced earlier, the companies were working together to develop and commercialize Eftilagimod Alfa in all markets outside North America, Europe, Japan and Greater China.
According to the disclosure, the Independent Data Monitoring Committee (IDMC) overseeing the TACTI-004 Phase III study recommended discontinuing the trial after conducting a planned interim futility analysis. The recommendation was made after reviewing available safety and efficacy data for the drug candidate being studied in patients with first-line non-small cell lung cancer.
Following the recommendation, enrolment of patients into the study will be halted and Immutep will proceed with an orderly wind-down of the trial. This process will include appropriate patient follow-up and closure of trial sites in line with regulatory and ethical requirements.
Immutep has also indicated that it is conducting a comprehensive evaluation of the data generated from the study to better understand the results and determine the future course of the development program for Eftilagimod Alfa.
Dr Reddy’s Laboratories stated that its subsidiary has so far only made the upfront payment to Immutep under the collaboration agreement and continues to engage with the partner company to determine the appropriate way forward. Meanwhile, Immutep has said it remains focused on advancing its broader pipeline of innovative therapies, including Eftilagimod Alfa.
