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The OncFive: Top Oncology Articles for the Week 9/22
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The FDA’s ODAC votes against the risk:benefit profile of frontline PD-1 inhibitors in select tumor types, osimertinib gains approval for select NSCLC, and more this week from OncLive.
Welcome to OncLive®’s OncFive! Every week, we will compile the top 5 stories in oncology, ranging from pivotal regulatory decisions to news updates and expert interviews spanning tumor types.
Here’s what you may have missed this week:
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 10 to 2 with 1 abstention against the risk:benefit profile of PD-1 inhibitors in the frontline treatment of patients with advanced HER2-negative, microsatellite stable gastric/gastroesophageal junction (GEJ) adenocarcinoma with a PD-L1 expression under 1. During the meeting, data from the phase 3 CheckMate 649 (NCT02872116), KEYNOTE-859 (NCT03675737), and RATIONALE-305 (NCT03777657) studies were presented. In a presentation on behalf of the regulatory agency, Vaibhav Kumar, MD, MS, noted that PD-L1 expression appears to be a predictive biomarker for HER2-negative gastric/GEJ adenocarcinoma and uncertainty surrounds the efficacy of PD-1 inhibitors in those with a PD-L1 expression less than 1 and that the use of these agents exposes patients to potential added toxicities.
NDA Resubmitted for Camrelizumab Plus Rivoceranib in Unresectable HCC
Following the receipt of a complete response letter (CRL) from the FDA in May 2024 for the initial new drug application (NDA) seeking the approval of camrelizumab plus rivoceranib in the first-line treatment of patients with unresectable hepatocellular carcinoma, the application has been resubmitted for review. The CRL had cited practice deficiencies at the facility that manufactures camrelizumab and incomplete Bioresearch Monitoring clinical inspections because of travel restrictions; no issues associated with manufacturing site or clinical data for rivoceranib had been cited.
FDA Approves Osimertinib for Locally Advanced, Unresectable EGFR+ NSCLC After Chemoradiation
On September 25, 2024, osimertinib (Tagrisso) won approval from the FDA for use in adult patients with locally advanced, unresectable, stage III non–small cell lung cancer whose disease had not progressed during or after concurrent or sequential platinum-based chemoradiation and whose tumors harbored EGFR exon 19 deletions or exon 21 L858R mutations. The decision was based on findings from the phase 3 LAURA study (NCT03521154) in which osimertinib (n = 143) improved progression-free survival (PFS) over placebo (n = 73) in this population (HR, 0.16; 95% CI, 0.10-0.24; P < .001).
The FDA’s ODAC voted 11 to 1 with 1 abstention against the risk:benefit profile of anti–PD–1 antibodies in the frontline treatment of patients with metastatic or unresectable esophageal squamous cell carcinoma (ESCC) and a PD-L1 expression under 1. Findings from the phase 3 KEYNOTE-590 (NCT03189719), CheckMate 648 (NCT03143153), and RATIONALE-306 (NCT03783442) studies were shared during the meeting. Geetika Srivastava, MD, MSPH, presented data from a patient-level analysis of an FDA ESCC-modified population of patients from each of the studies. An overall survival benefit was observed with PD-L1 inhibitors vs comparator arms; however, in the subsets of patients with a PD-L1 expression below 1, the difference between the arms was either not significantly different or did not favor the immunotherapy.
FDA Approves Selpercatinib for RET Fusion+ Medullary Thyroid Cancer
On September 27, 2024, traditional approval was granted to selpercatinib (Retevmo) from the FDA for use in adult and pediatric patients aged 2 years and older with RET fusion–positive, advanced or metastatic medullary thyroid cancer who required systemic therapy. The decision was supported by findings from the phase 3 LIBRETTO-531 study (NCT04211337) in which selpercatinib (n = 193) improved PFS over physician’s choice (n = 98) of cabozantinib (Cabometyx) or vandetanib (Caprelsa; HR, 0.280; 95% CI, 0.165-0.475; P < .0001).
