The OncFive: Top Oncology Articles for the Week of 12/29

OncLive’s December Roundup of Key FDA Approvals in Oncology

This article provides a snapshot of all therapeutic options that the FDA cleared in December 2024, including durvalumab (Imfinzi) in limited-stage small cell lung cancer on 12/4, zenocutuzumab-zbco (Bizengri) in NRG1 fusion–positive non–small cell lung cancer (NSCLC) and pancreatic adenocarcinoma on 12/4, cosibelimab-ipdl (Unloxcyt) in metastatic or locally advanced cutaneous squamous cell carcinoma on 12/13, ensartinib (Ensacove) in locally advanced or metastatic ALK-positive NSCLC, and more. The recap spotlights the topline findings supporting the decisions and features expert insights on what they mean for clinical practice.

FDA Approves Subcutaneous Nivolumab in Advanced or Metastatic Solid Tumors

Recently, on 12/27, the regulatory agency gave the green light to nivolumab and hyaluronidase-nvhy (Opdivo Qvantig) for subcutaneous injection across approved adult, solid tumor nivolumab (Opdivo) indications as monotherapy, monotherapy maintenance after nivolumab plus ipilimumab (Yervoy) completion, or paired with chemotherapy or cabozantinib (Cabometyx). The approval is based on findings from the phase 3 CheckMate 67T (NCT04810078), which demonstrated that the lower boundary of 90% confidence interval of geometric mean ratios was not less than 0.8 for both serum nivolumab Cavg over 28 days and Cmin at steady state.

Critical Recent NCCN Guideline Updates Affect Dozens of Malignancies

In 2024, tumor-agnostic approvals were incorporated into several updates of the NCCN guidelines spanning 20 different cancers. Notable additions included repotrectinib (Augtyro) for patients 12 years or older with solid tumors harboring a NTRK gene fusion and fam-trastuzumab deruxtecan-nxki (Enhertu) for adult patients with unresectable or metastatic HER2-positive solid tumors. In this exclusive recap article, experts detail how recent guideline changes are affecting practices. We also packaged all of the updates spanning tumor types into a slideshow resource, that you can only find on OncLive®.

FDA Approves Tislelizumab Plus Chemo for PD-L1+ Unresectable or Metastatic Gastric/GEJ Cancer

The regulatory agency also cleared frontline tislelizumab-jsgr (Tevimbra) for use in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with unresectable or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1. The decision is supported by findings from the phase 3 RATIONALE-305 study (NCT03777657). The combination led to a 20% reduction in the risk of death vs chemotherapy alone, at a median of 15.0 months and 12.9 months, respectively (HR, 0.80; 95% CI, 0.70-0.92; P = .0011).

T-DXd Plus Pembrolizumab Elicits Responses in IO-Naive HER2-Expressing or -Mutant NSCLC

Data from the interim analysis of the phase 1b DS8201-A-U106 study (NCT04042701) showed that when trastuzumab deruxtecan was paired with pembrolizumab (Keytruda), it elicited a confirmed objective response rate (cORR) of 54.5% (95% CI, 32.2%-75.6%) in those with HER2-expressing NSCLC (cohort 3; n = 22). In those with HER2-mutant NSCLC (cohort 4; n = 33), the cORR with the regimen was 66.7% (95% CI, 48.2%-82.0%). In those with previously untreated, HER2-expressing NSCLC (n = 8), the cORR was 62.5% (95% CI, 24.5%-91.5%); in those with previously untreated, HER2-mutant NSCLC (n = 20), the cORR was 80.0% (95% CI, 56.3%-94.3%). Data from the study were presented at the 2024 ESMO Immuno-Oncology Congress.