S6 Ep1: Cancer Data from European Conference May Lead to FDA Approvals

Last week, the European Society of Medical Oncology (EMSO) held their annual Congress in Madrid. The conference brought together cancer researchers from around the globe, who presented their clinical trial data — some of which has the potential to change the way cancers are treated.


For example, the Food and Drug Administration (FDA) approves therapies based on study data that proves that the regimen in question is safe, effective and superior to what is currently being used in that indication. While we don’t have a crystal ball and can’t say for sure if and when the FDA will approve a regimen, we can reflect on data presented at ESMO that we know the agency is considering and give our audience some potential oncology approvals that they should look out for.



Welireg Outperforms Afinitor in Advanced Clear Cell Kidney Cancer

The FDA is currently reviewing the phase 3 LIFESPARK-005 trial, comparing Welireg to Afinitor for patients with pretreated advanced clear cell renal carcinoma. Data from LIFESPARK-005, which were presented at the ESMO Congress, showed that Welireg outperformed Afinitor when it came to progression-free survival (that’s the time a patient lives after treatment without their disease worsening) and objective response rate (which describes the percentage of patients whose disease shrinks or disappears from treatment). However, there was no significant difference in overall survival (time from treatment unitl death of any cause) observed between the Welireg and Afinitor groups. The FDA is set to make their decision on this Welireg indication by Jan. 17, 2024.



Keytruda Plus Chemoradiotherapy Bests Standard of Care in Advanced Cervical Cancer

Also on the FDA’s docket for review is findings from the phase 3 KEYNOTE-A18 trial, investigating the addition of Keytruda to external beam radiotherapy — known as EBRT — and concurrent chemotherapy and followed by brachytherapy, for the treatment of patients with newly diagnosed, high-risk locally advanced cervical cancer. Study findings, which were presented at the ESMO Congress, showed that adding the immunotherapy agent to the regimen improved progression-free survival, overall survival and response rates. One expert, Dr. Bradley J. Monk, even commented, “This is a celebration for patients because we’re challenging a treatment paradigm that has stood for more than two decades.” The FDA stated that it plans to make its approval decision of Keytruda in this indication by Jan. 20, 2024.


Data Supporting FDA Approval of Pre- and Postsurgical Keytruda for Advanced Lung Cancer Presented


Days before ESMO, the FDA also approved Keytruda for the pre- and postsurgical treatment of patients with resectable (able to be removed via surgery) stage 2, 3A or 3B non-small cell lung cancer (NSCLC).

The approval is based off findings from the phase 3 KEYNOTE-671 trial, which compared treatment with presurgical Keytruda plus chemotherapy followed by postsurgical Keytruda against presurgical placebo plus chemotherapy, followed by placebo.


According to the FDA, overall survival (the time from treatment until death of any cause) was not reached in the Keytruda group, meaning not enough patients in that cohort had died to determine an average time until death. The median overall survival time was 52.4 months in the placebo group.


Study findings presented at EMSO showed improvements in event-free survival (the time a patient lives without any disease-related occurrences, such as a recurrence/relapse or death), which was also not yet reached among patients in the Keytruda arm of the study.


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