The OncFive: Top Oncology Articles for the Week of 8/18

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 First-Line Amivantamab Plus Lazertinib for EGFR+ Advanced NSCLC

On August 20, 2024, the regulatory agency gave the green light to the frontline combination of amivantamab-vmjw (Rybrevant) plus lazertinib (Lazcluze) for use in adult patients with locally advanced or metastatic non–small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R substitution mutations. The decision follows and is supported by, findings from the phase 3 MARIPOSA study (NCT04487080) in which the doublet (n = 429) led to a median progression-free survival (PFS) of 23.7 months vs 16.6 months with osimertinib (Tagrisso; n = 429), translating to a 30% reduction in the risk of disease progression or death (HR, 0.70).

Oncology Community Mourns the Loss of Dr Jeffrey S. Weber

This past week, the oncology community lost Jeffrey S. Weber, MD, PhD, a pioneer in the field of cancer immunotherapy and a leader in the realm of melanoma research. Weber was an inductee of the 2016 Giants of Cancer Care^® award in Melanoma. He also served as deputy director of the Laura and Isaac Perlmutter Cancer Center; the Laura and Isaac Perlmutter Professor of Oncology in the Department of Medicine at New York University (NYU) Grossman School of Medicine; director of the Experimental Therapeutics Program; and co-leader of the Clinical Melanoma Program Board at NYU Langone Health.

FDA Issues Complete Response Letter to Linvoseltamab BLA in R/R Multiple Myeloma

A biologics license application seeking the approval of linvoseltamab (REGN5458) for use in patients with relapsed or refractory multiple myeloma that has progressed after 3 or more prior therapies has been issued a complete response letter from the FDA. The sole approvability issue was associated with findings from a pre-approval inspection at a third-party fill/finish manufacturer for another company’s product candidate. The manufacturer has informed Regeneron Pharmaceuticals, Inc., the drug developer, that they believe the issue has since resolved and the regulatory agency is slated to reinspect the facility in the coming months.

Case Study Highlights an Approach to Adjuvant Treatment in RCC

On World Kidney Cancer Day, Emre Yekedüz, MD, a research fellow at Dana-Farber Cancer Institute, shared the following case study on OncLive®’s X account: “A 62-year-old man underwent radical nephrectomy for a 75 mm left renal mass diagnosed as clear cell renal cell carcinoma with sarcomatoid features. The tumor invaded perirenal sinus fat but did not beyond Gerota’s fascia, with clear surgical margins. Imaging revealed no distant metastases. What’s the next step?” The options were observation, adjuvant nivolumab (Opdivo), adjuvant pembrolizumab (Keytruda), or adjuvant sunitinib (Sutent). In this exclusive interview, Yekedüz walks through the poll results and data supporting how to treat this patient.

FDA Lifts Partial Clinical Hold on Phase 1 Trial of YL202 in NSCLC and Breast Cancer

The partial clinical hold placed on the phase 1 YL202-INT-101-01 trial (NCT05653752), which is examining YL202 (BNT326) in patients with locally advanced or metastatic non–small cell lung cancer and EGFR mutations or hormone receptor–positive, HER2-negative breast cancer, has been lifted. The hold had been initiated after 5 patients who received treatment with the agent in the YL202-INT-101-01 and phase 2 YL202-CN-201-01 (NCT06107686) trials experienced grade 5 toxicities. The trial will resume enrollment in the United States, but patients will not receive YL202 at doses higher than 3 mg/kg.