The OncFive: Top Oncology Articles for the Week of 9/29

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:

FDA Approves Perioperative Nivolumab for Resectable NSCLC

On October 3, 2024, the FDA approved neoadjuvant nivolumab (Opdivo) plus platinum-doublet chemotherapy, followed by adjuvant nivolumab monotherapy after surgery, for adults with resectable non–small cell lung cancer and no known EGFR mutations or ALK rearrangements based on data from the phase 3 CheckMate-77T trial (NCT04025879). The median event-free survival was not reached (95% CI, 28.9-not estimable [NE]) in the nivolumab arm (n = 229) vs 18.4 months (95% CI, 13.6-28.1) in the chemotherapy arm (n = 232; HR, 0.58; 95% CI, 0.43-0.78; P = .00025).

Locally Produced CAR T-Cell Therapy Elicits 92% ORR in R/R Multiple Myeloma

Treatment with the academically sourced and produced, second-generation, BCMA-directed CAR T-cell therapy HBI0101 resulted in an objective response rate (ORR) of 92% in patients with relapsed/refractory multiple myeloma (n = 84), according to updated data from a phase 1 trial (NCT04720313). Data, which were presented at the 21st International Myeloma Society Annual Meeting, indicated that the stringent complete response (CR)/CR rate was 55%, the very good partial response rate was 21%, the partial response rate was 16%, and the rate of progressive disease was 8%.

FDA Grants Priority Review to Acalabrutinib in Treatment-Naive Mantle Cell Lymphoma

The FDA has granted priority review to the supplemental new drug application seeking the approval of acalabrutinib (Calquence) for the treatment of patients with previously untreated mantle cell lymphoma. The application is supported by data from the phase 3 ECHO trial (NCT02972840), which showed that at a median follow-up of 45 months, those who received acalabrutinib plus bendamustine and rituximab (Rituxan; BR; n = 299) experienced a median progression-free survival (PFS) of 66.4 months (95% CI, 55.1-NE) vs 49.6 months (95% CI, 36.0-64.1) for those given placebo plus BR (n = 299; HR, 0.73; 95% CI, 0.57-0.94; P = .0160).

OncLive’s September Roundup of Key FDA Approvals in Oncology

This snapshot spotlights 8 key regulatory approvals that occurred in September 2024, including the anticipated decisions regarding adjuvant ribociclib (Kisqali) plus an aromatase inhibitor in hormone receptor–positive, HER2-negative stage II and III early breast cancer at high risk of recurrence; isatuximab-irfc (Sarclisa) plus bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone in newly diagnosed multiple myeloma who are not candidates for transplant; and amivantamab-vmjw (Rybrevant) plus chemotherapy for locally advanced or metastatic NSCLC and EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after EGFR inhibition.

Revisit Every OncLive On Air Episode From September 2024

This recap spotlights the 9 total episodes of OncLive On Air that were released in September 2024. Among the top episodes were those of the FDA Approval Insights subseries, featuring insights from Jennifer Crombie, MD, of Dana-Farber Cancer Institute, and Allison Betof Warner, MD, PhD, who spoke to the approvals of epcoritimab-bysp (Epkinly) in relapsed/refractory follicular lymphoma and afamitresgene autoleucel (Tecelra) in unresectable or metastatic synovial sarcoma, respectively; and an installment of How This Is Building Me, where host D. Ross Camidge, MD, PhD, sat down with Kadrin Wifong, MD, of PeerView Institute for Medical Education, to discuss the life events that led Wilfong to medical school and how she jumpstarted her career in oncology-focused education.