Bristol-Myers Squibb (BMS) said Thursday that it had voluntarily pulled its application for research into Opdivo and Yervoy combination therapy in treating patients with previously untreated non-small cell lung cancer (NSCLC) with tumor mutational burden (TMB).

The company plans to reinvestigate the relationship between the PD-L1 rate, which is the current biomarker standard, and TMB, and reapply for the combination treatment.

"We decided to retract because it was difficult to review the data during the approval review period,” the company said in a statement. ”After discussing with the licensing authority, the company plans to provide additional data on indications for NSCLC between the current biomarker standard PD-L1 and the new TMB standard."

The withdrawal comes after the U.S. Food and Drug Administration revised the approval timeline, which was originally scheduled for Feb. 20 to May.

The FDA based the approval process for the combination of Opdivo and Yervoy on Part 1 of the CheckMate-227 3 Standing Phase presented at the annual American Association for Cancer Research (AACR) annual conference in April last year.

During the presentation, the company compared the overall survival (OS) benefits of different non-small cell lung cancer patients with TMB-expressing biomarker mutation criteria.

In patients with a TMB deviation of at least 10 mut / Mb, the median OS value was 23.03 months, which was higher than the 16.72 months for the chemotherapy group.

However, BMS claims that it needs more evidence to assess the duo’s impact on survival. The company plans to add the Checkmate-227 trial, set to arrive in the first half of this year.

“Since these data from Checkmate -227, Part 1a, will not be available within the review cycle of the current application the company decided to withdraw,” the company said.

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