Commentary

Podcast

FDA Approval Insights: Zolbetuximab for CLDN18.2+ HER2-Negative Gastric and GEJ Adenocarcinoma

Fact checked by:

Dr Ajani discusses the FDA approval of frontline zolbetuximab plus chemo for unresectable or metastatic, HER2–, CLDN18.2+ gastric or GEJ adenocarcinoma.

Welcome to OncLive On Air®! I’m your host today, Jax DiEugenio.

OncLive On Air is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, supported by Astellas Pharma, we had the pleasure of speaking with Jaffer A. Ajani, MD, about the FDA approval of zolbetuximab-clzb (Vylov) plus chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are Claudin 18.2 (CLDN18.2) positive. Dr Ajani is a GI medical oncologist and professor in the Department of Gastrointestinal (GI) Medical Oncology in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston.

On October 18, 2024, the FDA approved zolbetuximab plus fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of adult patients with locally advanced unresectable or metastatic, HER2-negative, CLDN18.2-positive gastric or GEJ adenocarcinoma. This regulatory decision was backed by findings from the phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) trials. In SPOTLIGHT, In SPOTLIGHT, patients who received zolbetuximab plus mFOLFOX6 (5-fluorouracil, leucovorin, and oxaliplatin) achieved a median progression-free survival (PFS) of 10.6 months (95% CI, 8.9-12.5) vs 8.7 months (95% CI, 8.2-10.3) in those who received placebo plus chemotherapy (HR, 0.750; 95% CI, 0.601-0.936; 1-sided P = .0053). In GLOW, zolbetuximab plus CAPOX (capecitabine and oxaliplatin) generated a median PFS of 8.2 months (95% CI, 7.5-8.8) vs 6.8 months (95% CI, 6.1-8.1) with placebo plus CAPOX (HR, 0.771; 95% CI, 0.615-0.965; 1-sided P = .0118).

In our exclusive interview, Dr Ajani discussed key considerations for the clinical use of zolbetuximab, including its anticipated adverse effect profile and the introduction of CLDN18.2 as a biomarker for assessment prior to treatment initiation.

___

That’s all we have for today! Thank you for listening to this episode of OncLive On Air, supported by Astellas Pharma. Check back on Mondays and Thursdays for exclusive interviews with leading experts in the oncology field.

For more updates in oncology, be sure to visit www.OncLive.com and sign up for our e-newsletters.

OncLive is also on social media. On X, follow us at @OncLive. On Facebook, like us at OncLive, and follow our OncLive page on LinkedIn.

If you liked today’s episode of OncLive On Air, please consider subscribing to our podcast on Apple Podcasts, Spotify, Amazon Music, and many of your other favorite podcast platforms,* so you get a notification every time a new episode is posted. While you are there, please take a moment to rate us!

Thanks again for listening to OncLive On Air.

*OncLive On Air is available on: Apple Podcasts, Google Podcasts, Spotify, Amazon Music, Audacy, CastBox, Deezer, iHeart, JioSaavn, Listen Notes, Player FM, Podcast Addict, Podchaser, RadioPublic, and TuneIn.

Related Videos
Shubham Pant, MD, MBBS
Chad Tang, MD
Elias Jabbour, MD, professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
Chad Tang MD, MD Anderson
Bora Lim, MD, MD Anderson
Robert Z. Orlowski, MD, PhD, and Jonathan Kaufman, MD
Guillermo Garcia-Manero, MD
Eric Jonasch, MD, professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
Robert Z. Orlowski, MD, PhD, and Jonathan Kaufman, MD
Robert Z. Orlowski, MD, PhD, and Jonathan Kaufman, MD