Regulatory FDA not confident in GSK's therapy for rectal cancer

FDA not confident in GSK’s therapy for rectal cancer


There has been a lot of media coverage that showed keen interest in a rectal cancer clinical study of GSK’s Jemperli (rectal cancer therapy) in its early stages. Despite all this coverage, the FDA is still not on board.

The FDA questioned whether it was acceptable for GSK to utilise tumor complete response data from single-arm studies to support approval in locally advanced rectal cancer when curing the illness is the aim. The FDA brought up the issues in a briefing paper created for a meeting of outside oncology specialists.

In early-stage rectal cancer that has been discovered to have the mismatch repair deficient biomarker, GSK intends to convince FDA to award Jemperli an expedited authorization for usage before any therapy. PD-1 inhibitors are now licensed for use in patients with advanced or recurrent solid tumors who have received therapies in the past or who have no other therapy alternatives.

The FDA may hesitate and frequently request more mature patient survival statistics to support the application in cases of early-stage cancer, where patients may be cured with existing medications.

GSK currently has clinical trial results from the Memorial Sloan Kettering Cancer Center. According to information provided at the American Society of Clinical Oncology’s annual conference in 2022, none of the patients who got the GSK medication before surgery showed any indication of remaining illness at the time of the study’s intermediate analysis. Although the statistics were remarkable, just 14 patients were included, and only half of them were tracked for more than a year. In this cohort, the experiment plans to recruit a total of 30 participants.

For the confirmatory package, GSK intends to increase patient follow-up in the Memorial Sloan Kettering and GSK investigations. In addition, GSK said that it would begin a randomized, international phase 3 trial to contrast Jemperli with conventional chemotherapy to expand its expertise. The FDA is now asking its oncologic advisory group to debate whether full response data from single-arm studies would be sufficient.

GSK is hopeful that the 12-month complete response data may be “reasonability likely to predict clinical benefit based on the published literature in the chemotherapy and immuno-oncology settings,” and therefore, could back an accelerated approval.

The organisation has raised a few questions if there should be more representation of a high-risk category in the research population. Additionally, the FDA is not confident about the significance of the results from the phase 3 study, which GSK offered as evidence that supports the confirmatory package.

Chemotherapy, chemoradiotherapy, and surgery are among the recommended treatments for locally advanced rectal cancer. There are several challenges in the treatment even if it could cure the condition. GSK is hoping that Jemperli will offer a non-operative option that is the same treatment potential but no side effects.

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