Welcome to OncLive®’s OncFive!
Every week, we bring you a quick roundup of the 5 top stories from the world of oncology—ranging from pivotal regulatory decisions to key pipeline updates to expert insights on breakthroughs that are moving the needle in cancer care. This resource is designed to keep you informed on the latest updates in the space, in just a matter of minutes.
Here’s what you may have missed this week:
The regulatory agency gave the green light to cabozantinib (Cabometyx) for use in adult and pediatric patients aged 12 years or older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic (pNET) and extrapancreatic (epNET) neuroendocrine tumors based on data from 2 cohorts of the phase 3 CABINET study (NCT03375320). In the pNET (n = 99) and epNET (n = 199) cohorts, the hazard ratios (HRs) for median progression-free survival with cabozantinib vs placebo was 0.22 (95% CI, 0.12-0.41; P < .0001) and 0.40 (95% CI, 0.26-0.61; P < .0001), respectively. “This approval really means that we have a new standard option to offer to patients with NETs who have had at least 1 other line of therapy and whose disease is progressing and needs additional therapy to control growth,” Jennifer Chan, MD, MPH, of Dana-Farber Cancer Institute, said in an exclusive interview with OncLive.
The FDA has approved durvalumab (Imfinzi) paired with gemcitabine and cisplatin as neoadjuvant treatment, followed by durvalumab monotherapy as adjuvant treatment following radical cystectomy, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). The decision was based on findings from the phase 3 NIAGRA trial (NCT03732677), which demonstrated that the HR for event-free survival with the durvalumab approach vs neoadjuvant chemotherapy alone was 0.68 (95% CI, 0.56-0.82; 2-sided P < .0001). “The significance of the approval of perioperative durvalumab for the treatment of patient with MIBC is that it really represents the first time that a treatment has been added to the standard cisplatin-based chemotherapy in the neoadjuvant setting, which has improved outcomes,” Matthew Galsky, MD, of Mount Sinai, Tisch Cancer Institute, said in an interview with OncLive.
The indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto) has been expanded by the FDA to include adult patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor therapy and are considered appropriate to delay taxane-based chemotherapy. The decision was supported by findings from the phase 3 PSMAfore trial (NCT04689828), which showed that the agent (n = 234) led to a median radiographic progression-free survival of 9.3 months (95% CI, 7-not estimable) compared with 5.6 months (95% CI, 4-6) for those who switched to a different AR pathway inhibitor (n = 234; HR, 0.41; 95% CI, 0.29-0.56; P < .0001). “The FDA’s expanded approval of [lutetium Lu 177 vipivotide tetraxetan] marks a transformative step forward in the treatment of mCRPC, underscoring the growing impact of precision oncology,” Jorge A. Garcia, MD, of University Hospitals Seidman Cancer Center/Case Western Reserve University, told OncLive.
Ahead of the 51st Annual EBMT Meeting, OncLive asked hematology and transplant experts to share their insights on the research and presentations they are most excited to hear more about. Sign up to gain access to this exclusive preview featuring perspectives from Steven Devine, MD, of NMDP and the CIBMTR; Everett Meyer, MD, PhD, of Stanford University and Stanford Cancer Institute; and Sophie Paczesny, MD, PhD, of the Hollings Cancer Center at the Medical University of South Carolina. A couple of abstracts that made the list included: OS6-02: Targeting Cathepsin G With a Dual HLA-Restricted TCR: A Promising Therapy for Acute Myeloid Leukemia and OS3-04: Observational Comparison of Overall Survival Between Phase 1b Orca-T and Registry-Based Post-Transplant Cyclophosphamide Patients.
Updated data from the phase 3 MARIPOSA trial (NCT04487080) indicated that frontline amivantamab-vmjw (Rybrevant) paired with lazertinib (Lazcluze) significantly improved overall survival (OS) compared with osimertinib (Tagrisso) in patients with EGFR-mutant non–small cell lung cancer. At a median follow-up of 37.8 months, the median OS with the doublet (n = 429) and osimertinib (n = 429) was not reached (NR; 95% CI, 42.9-NR) and 36.7 months (95% CI, 33.4-41.0), respectively (HR, 0.75; 95% CI, 0.61-0.92; P < .005). “Patients live longer with first-line amivantamab plus lazertinib, with MARIPOSA demonstrating practice-changing superior OS vs osimertinib and potentially extending median survival beyond 4 years,” James Chih-Hsin Yang, MD, PhD, of National Taiwan University Cancer Center, National Taiwan University Hospital, said in a presentation of the data during the 2025 European Lung Cancer Congress.