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T-DXd wins FDA approval in HER2-low and -ultralow breast cancer, 177 Lutetium edotreotide boosts PFS in GEP-NETS, and more from OncLive this week.
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 T-DXd for Pretreated HER2-Low and -Ultralow Metastatic Breast Cancer
The regulatory agency cleared to fam-trastuzumab deruxtecan-nxki (Enhertu) for use in adult patients with unresectable or metastatic, hormone receptor–positive, HER2-low or HER2-ultralow breast cancer that has progressed on at least 1 endocrine therapy in the metastatic setting. The median progression-free survival (PFS) with the antibody-drug conjugate (n = 436) led to a median progression-free survival of 13.2 months (95% CI, 12.0-15.2) vs 8.1 months (95% CI, 7.0-9.0) with chemotherapy (n = 430) in the overall population (HR, 0.64; 95% CI, 0.54-0.76; P < .0001), according to data from the phase 3 DESTINY-Breast06 study (NCT04494425).
177Lu-edotreotide Improves PFS in Grade 1/2 GEP-NETs in Phase 3 COMPETE Trial
The phase 3 COMPETE trial (NCT03049189) met its primary end point when 177 Lutetium edotreotide prolonged PFS vs everolimus (Afinitor) in patients with inoperable, progressive, grade 1 or 2 gastroenteropancreatic neuroendocrine tumors. The agent also had favorable tolerability. “The patients included represent a real-life scenario, and the study evaluates the important question of which therapy might be used first to provide greater benefit to patients,” Jaume Capdevila, MD, PhD, of Vall d’Hebron University Hospital, Barcelona, stated in a news release.
Inavolisib Combo Shows OS Benefit in Endocrine-Resistant, PIK3CA-Mutated, HR+ Breast Cancer
The combination of inavolisib (Itovebi) plus palbociclib (Ibrance) and fulvestrant (Faslodex) significantly improved overall survival (OS) over palbociclib/fulvestrant alone in patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer, meeting an important secondary end point of the phase 3 INAVO120 study (NCT04191499). Complete OS data will be shared at an upcoming medical conference. Data from the trial are also under review by global health authorities like the European Medicines Agency.
CARGO Therapeutics to Discontinue Phase 2 Study of Firi-Cel in R/R LBCL
CARGO Therapeutics announced that the phase 2 FIRCE-1 trial (NCT05972720) examining the safety and efficacy of firicabtagene autoleucel, a CD22-targeted CAR T-cell therapy, in patients with large B-cell lymphoma that is relapsed or refractory to a CD19-directed CAR T-cell therapy will be discontinued. Findings from the study did not support a competitive risk-benefit profile in this population. The therapy (n = 51) elicited an overall response rate of 77%, with a complete response rate of 43%. Full data will be submitted for presentation at an upcoming medical meeting.
Revisit Every OncLive On Air Episode From January 2025
This recap spotlights 12 total episodes of OncLive On Air that were released in January 2025. Among the top episodes was an installment of the Oncology Unplugged subseries in which Chandler Park, MD, sat down with Joshua Brody, MD, to discuss treatment challenges that arise across the diverse array of lymphomas, the evolution of lymphoma classification, updates in frontline Hodgkin lymphoma management, and novel therapies emerging for patients with diffuse large B-cell lymphoma; and an episode tied to a recent OncClub package, featuring Alexander Watson, MD, who discussed findings from a retrospective analysis of how oncogene overlap may demonstrate clinically relevant thresholds for MET, KRAS, and HER2 gene copy number gain in non–small cell lung cancer.