The OncFive: Top Oncology Articles for the Week of 11/10

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 Receives New BLA for Dato-DXd in Pretreated EGFR+ Advanced NSCLC

A new biologics license application (BLA) seeking the accelerated approval of datopotamab deruxtecan for use in adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR mutations who had previously received systemic treatment has been filed to the FDA. The application is supported by findings from the phase 2 TROPION-Lung05 trial (NCT04484142); it is also supported by data from the phase 3 TROPION-Lung01 (NCT04484142) and the phase 1 TROPION-PanTumor01 (NCT03401385) trials. Feedback from the regulatory agency led to the voluntary withdrawal of the original BLA seeking approval of the agent in advanced or metastatic nonsquamous disease.

RP1 Plus Nivolumab Is Active, Safe in Advanced Melanoma After Progression on Anti–PD-1 Therapy

Data from the phase 2 IGNYTE study (NCT03767348) presented at the 2024 SITC Annual Meeting showed that vusolimogene oderparepvec (RP1) paired with nivolumab (Opdivo) elicited responses in patients with advanced melanoma whose disease progressed on or following a PD-1 inhibitor. The combination (n = 140) led to a confirmed overall response rate of 33.6% (95% CI, 25.8%-42.0%). “RP1 combined with nivolumab after confirmed progression on anti–PD-1 therapy alone or in combination with anti–CTLA-4 [therapy] demonstrated a clinically meaningful rate and duration of response [DOR],” Michael K. Wong, MD, PhD, FRCPC, of The University of Texas MD Anderson Cancer Center in Houston, said during a presentation of the data.

177Lu-PSMA-I&T Meets rPFS End Point in PSMA+ mCRPC

The primary end point of the confirmatory phase 3 ECLIPSE trial (NCT05204927) was met when 177Lu-PSMA-I&T (lutetium [177Lu] zadavotide guraxetan) resulted in a statistically significant and clinically meaningful improvement in radiographic progression-free survival vs hormonal therapy in patients with metastatic castration-resistant prostate cancer. Curium Pharma noted that as the data from the trial continue to mature, they will continue to work with the FDA on a plan for regulatory submission.

Refined Definition of Platinum Resistance, Novel ADCs Could Bring More Changes to Ovarian Cancer Treatment

In an interview with OncLive following a State of the Science Summit™ on gynecologic cancers, which she chaired, Kathleen N. Moore, MD, MS, of Stephenson Cancer Center and the University of Oklahoma College of Medicine, discussed how mirvetuximab soravtansine-gynx (Elahere) has altered the ovarian cancer treatment paradigm, expanded on the evolving definition of platinum resistance, and highlighted other antibody-drug conjugates currently under development. “With additional data, we're about to change a lot of these paradigms for the betterment of patients [by providing a] better selection of drugs,” she said.

Isatuximab Plus VRd Earns CHMP Recommendation for Newly Diagnosed, Transplant-Ineligible Myeloma

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of isatuximab (Sarclisa) plus bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (VRd) for use in adult patients with newly diagnosed multiple myeloma who are not candidates to undergo autologous stem cell transplant. The opinion was supported by findings from the phase 3 IMROZ trial (NCT03319667) which showed that the isatuximab combination (n = 265) led to a median progression-free survival (PFS) that was not reached (NR) vs 54.34 months (95% CI, 45.207-NR) with VRd alone (n = 181); the respective PFS rates at 60 months were 63.2% and 45.2%.

Bonus: CHMP also had positive opinions regarding repotrectinib (Augtyro) in ROS1-positive NSCLC and NTRK-positive solid tumors, pembrolizumab (Keytruda) plus chemotherapy in unresectable non-epithelioid malignant pleural mesothelioma, nivolumab plus ipilimumab (Yervoy) in microsatellite instability–high/mismatch repair–deficient unresectable or metastatic colorectal cancer, and denosumab biosimilars for bone loss and giant cell tumor of the bone.