The OncFive: Top Oncology Articles for the Week of 10/20

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 Accepts NDA Resubmission for First-Line Rivoceranib/Camrelizumab Combo in Unresectable HCC

The FDA has accepted a resubmission of a new drug application (NDA) seeking the approval of rivoceranib plus camrelizumab as a first-line treatment in patients with unresectable or metastatic hepatocellular carcinoma based on data from the phase 3 CARES-310 trial. Previously, in May 2024, the regulatory agency had issued a complete response letter to the initial NDA for the combination, citing manufacturing deficiencies and incomplete bioresearch monitoring clinical inspections. Under the Prescription Drug User Fee Act, the current application has been issued a target action date of March 20, 2025.

Acalabrutinib Plus Venetoclax/Rituximab Yields 100% ORR in Treatment-Naive Mantle Cell Lymphoma

Data from a phase 1b study (NCT02717624) published in Blood Advances showed that a triplet regimen comprised of acalabrutinib (Calquence), venetoclax (Venclexta), and rituximab (Rituxan) produced an overall response rate of 100% (95% CI, 83.9%-100.0%) by Lugano criteria in previously untreated patients with mantle cell lymphoma (n = 21); the complete response rate was 71.4% (95% CI, 47.8%-88.7%). In terms of safety, 61.9% of patients experienced grade 3/4 treatment-emergent adverse effects, which included neutropenia (33.3%), COVID-19 (9.5%), diarrhea (4.8%), dyspnea (4.8%), and peripheral edema (4.8%).

FDA Approves Companion Diagnostic for Zolbetuximab in CLDN18.2+ Gastric/GEJ Cancer

The FDA gave the green light to the immunohistochemistry companion diagnostic Ventana® CLDN18(43-14A) RxDx Assay for use in identifying claudin 18.2 protein expression in patients with gastric or gastroesophageal junction adenocarcinoma who could be candidates for zolbetuximab-clzb (Vyloy), which recently won approval in the United States for use in the first-line setting when combined with fluoropyrimidine- and platinum-containing chemotherapy. The agent’s approval was supported by data from the phase 3 SPOTLIGHT and GLOW trials, which both leveraged the assay.

First-in-Class Bicycle Toxin Conjugate Targeting Nectin-4 Generates Excitement in Urothelial Carcinoma

The bicycle toxin conjugate zelenectide pevedotin (formerly BT8009) has demonstrated early efficacy as a monotherapy in patients with metastatic urothelial carcinoma who had not received enfortumab vedotin-ejfv (Padcev) in the phase 1/2 Duravelo-1 study (NCT04561362) and is under further investigation as a single agent and paired with pembrolizumab (Keytruda) in the currently enrolling phase 2/3 Duravelo-2 trial (NCT06225596). This clinical trial spotlight features insights from Terence W. Friedlander, MD, of University of California, San Francisco Helen Diller Family Comprehensive Cancer Center; Neal Shore, MD, FACS, of the Carolina Urologic Research Center; and Srikala Sridhar, MD, MSc, FRCPC, of Princess Margaret Cancer Centre.

Pembrolizumab Earns EU Approval in 2 New Indications for Endometrial and Cervical Cancer

The European Commission has approved pembrolizumab with carboplatin/paclitaxel for frontline use in adult patients with primary advanced or recurrent endometrial carcinoma who can receive systemic therapy; and with chemoradiotherapy for adult patients with International Federation of Gynecology and Obstetrics 2014 stage III to IVA locally advanced cervical cancer without prior definitive therapy. The indications are supported by findings from the phase 3 KEYNOTE-868 (NCT03914612) and KEYNOTE-A18 (NCT04221945) trials, respectively.