The OncFive: Top Oncology Articles for the Week of 3/2

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:

FDA Approves First-line Tislelizumab Plus Chemo for Unresectable or Metastatic ESCC

The regulatory agency cleared tislelizumab-jsgr (Tevimbra) plus platinum-containing chemotherapy for first-line use in adult patients with unresectable or metastatic esophageal squamous cell carcinoma with a tumor PD-L1 expression of 1 or higher. The decision is supported by data from the phase 3 RATIONALE-306 trial (NCT03783442), which showed that the tislelizumab combination (n = 326) led to a median overall survival (OS) of 17.2 months (95% CI, 15.8-20.1) vs 10.6 months (95% CI, 9.3-12.1) with chemotherapy alone (n = 323; stratified HR, 0.66; 95% CI, 0.54-0.80; 1-sided P < .0001). “This approval allows our patients to access additional options for treatment...,” Nataliya Uboha, MD, of University of Wisconsin Health, told OncLive. “Patients with this disease have a very poor prognosis. [ESCC is] incurable in the metastatic setting, and we definitely need more and better options for patients with this disease.”

Perioperative Durvalumab Plus Chemo Meets EFS End Point in Resectable Gastric/GEJ Cancer

Treatment with neoadjuvant durvalumab (Imfinzi) plus fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) followed by adjuvant durvalumab plus FLOT, then single-agent durvalumab, significantly improved event-free survival over perioperative placebo plus FLOT in patients with resectable, stage II, III, or IVA gastric and gastroesophageal junction cancer, meeting the primary end point of the phase 3 MATTERHORN trial (NCT04592913). A strong OS trend favoring the durvalumab arm was also observed. The full findings from the interim analysis are slated to be shared at an upcoming medical meeting and discussed with health authorities on a global scale.

T-DXd Improves OS in Unresectable/Metastatic HER2+ Gastric/GEJ Adenocarcinoma

The primary end point of the phase 3 DESTINY-Gastric04 trial (NCT04704934) was met when fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) significantly improved OS vs ramucirumab (Cyramza) plus paclitaxel when used as second-line treatment in patients with HER2-positive unresectable and/or metastatic gastric or gastroesophageal junction adenocarcinoma. The data will be shared at an upcoming medical conference and discussed with global health authorities. The antibody-drug conjugate is the first HER2-directed medicine to demonstrate an OS improvement in a randomized phase 3 trial in this setting and disease, according to Ken Takeshita, MD, of Daiichi Sankyo.

Rusfertide Meets Response End Point in Phlebotomy-Dependent Polycythemia Vera

When rusfertide was paired with standard-of-care (SOC) therapy, it led to improved responses vs placebo in patients with phlebotomy-dependent polycythemia vera, which met the primary end point of the phase 3 VERIFY study (NCT05210790). The clinical response rate with rusfertide in weeks 20 and 32 was 77% vs 33% with placebo (P < .0001). Moreover, 4 important secondary end points were also met. Those in the rusfertide arm received a mean of 0.5 phlebotomies compared with 1.8 phlebotomies for those in the placebo arm in weeks 0 to 32 (P < .0001). Rusfertide also led to better hematocrit control and improved patient-reported outcomes using PRPMIS Fatigue SF-8a and MFSAF TSS-7 vs placebo. “The positive results of the phase 3 VERIFY study across the primary and all key secondary end points provide compelling evidence of the potential for rusfertide as a first-in-class erythrocytosis-specific agent to address unmet medical needs in patients with PV who are unable to achieve adequate hematocrit control despite SOC treatments,” Arturo Molina, MD, MS, of Protagonist, said in a news release.

177Lu-edotreotide Radiopharmaceutical Therapy Prolongs PFS vs Everolimus in SSTR+ GEP-NETs

The phase 3 COMPETE trial (NCT03049189) also met its primary end point when 177 Lutetium edotreotide (177Lu-edotreotide; ITM-11) significantly improved progression-free survival (PFS) compared with everolimus (Afinitor) in patients with grade 1 or 2 somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors. Topline findings indicated that 177Lu-edotreotide (n = 207) led to a median PFS of 23.9 months vs 14.1 months with everolimus (n = 102; HR, 0.67; 95% CI, 0.48-0.95; P = .022). “These data show unequivocal support for 177Lu-edotreotide’s potential benefit in extending PFS,” Jaume Capdevila, MD, PhD, of Vall d’Hebron University Hospital, stated in a news release. “Additionally, 177Lu-edotreotide’s convenient dosing schedule and favorable safety results reinforce its potential as a compelling new treatment option.”