Hyderabad-based drug maker Dr Reddy’s Laboratories Ltd on Friday (March 13) said its wholly-owned subsidiary, Dr Reddy’s Laboratories SA, has been advised by the Independent Data Monitoring Committee (IDMC) to discontinue the phase III TACTI-004 trial of eftilagimod alfa in first-line non-small cell lung cancer.
The recommendation followed a planned interim futility analysis in line with the study protocol, based on available safety and efficacy data.
In response to the IDMC’s recommendation, enrolment in the study will be halted, and Immutep SAS, a wholly-owned subsidiary of Immutep Limited, will implement an orderly wind-down of the trial. This includes appropriate patient follow-up and site close-out in accordance with regulatory and ethical obligations.
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Immutep said it is undertaking a comprehensive review of the available data to better understand the results and determine the appropriate next steps for the eftilagimod alfa programme.
Dr Reddy’s SA has, to date, made only the upfront payment to Immutep and continues to engage with the company on the appropriate way forward. The company noted that Immutep remains focused on advancing its pipeline of innovative therapies, including eftilagimod alfa.
“We continue to work closely with Immutep to evaluate the study outcomes and determine the next steps for the program. Patient safety and regulatory compliance remain our top priorities,” it added.
Shares of Dr Reddy’s Laboratories Ltd ended at ₹1,288.40, down by ₹30.35, or 2.30%, on the BSE today, March 13.
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(Edited by : Shoma Bhattacharjee)
