The OncFive: Top Oncology Articles for the Week of 11/3

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 Approves Obecabtagene Autoleucel for R/R B-Cell Precursor Acute Lymphoblastic Leukemia

The CD19-directed autologous CAR T-cell therapy obecabtagene autoleucel (obe-cel; Aucatzyl) received FDA approval for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Friday’s regulatory decision was supported by data from the phase 1/2 FELIX trial (NCT04404660), where findings demonstrated obe-cel elicited a complete remission (CR) rate of 42% (95% CI, 29%-54%) within 3 months of infusion among evaluable patients (n = 65), The median duration of CR for those who responded within 3 months was 14.1 months (95% CI, 6.1–not reached).

FDA Approval Sought for Sunvozertinib in Pretreated EGFR Exon 20+ Advanced NSCLC

The FDA received a new drug application (NDA) seeking the approval of sunvozertinib (DZD9008) for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

In the phase 2 WU-KONG1 trial (NCT03974022), sunvozertinib elicited a best overall response rate (ORR) of 53.3% (97.5% CI, 42.0%-64.3%) and a confirmed ORR of 44.9% (97.5% CI, 34.0%-56.1%).

Notably, the agent was approved in China in the same indication in August 2023.

Obinutuzumab and Liso-Cel Revisions to CLL/SLL NCCN Guidelines Mark Most Notable Changes of 2024

In an interview with OncLive, Matthew Cortese, MD, MPH, of Roswell Park Comprehensive Cancer Center in Buffalo, New York, detailed notable updates to the National Comprehensive Cancer Network Guidelines for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). He noted how these changes have affected his practice and spotlighted treatments to look forward to in the future.

In particular, Cortese highlighted two key changes within the CLL space: the addition of venetoclax (Venclexta) plus obinutuzumab (Gazyva) to the list of preferred regimens in the second- or later-line settings for patients with and without 17p deletions/TP53 mutations, plus the approval of the first CAR T-cell therapy approved in CLL, lisocabtagene maraleucel (Breyanzi).

Brahmer's Take: Advancements in 3 Cornerstone Settings of NSCLC

In another interview with OncLive, Julie R. Brahmer, MD, MSc, of Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medicine in Baltimore, Maryland, detailed practice-changing FDA approvals across the NSCLC space in 2024 and expanded on notable data in the early-stage, perioperative, and metastatic NSCLC settings.

“The most important advances of this year thus far are in early-stage NSCLC with the advent of neoadjuvant immunotherapy plus chemotherapy,” Brahmer said. “We know that patients with stage II and stage IIIA disease benefit from neoadjuvant therapy, and there are multiple perioperative paradigms that are now approved for giving neoadjuvant chemotherapy and immunotherapy followed by immunotherapy in the adjuvant setting, as well.”

Continued Development of RAS Inhibitors Leads the Charge in Pancreatic Cancer Research

November is Pancreatic Cancer Awareness Month, and to kick it off, Tanios S. Bekaii-Saab, MD, of Mayo Clinic in Phoenix, Arizona, sat down with OncLive to discuss ongoing research across the pancreatic cancer space, particularly focusing on the continuous efforts to develop RAS inhibitors for the treatment of patients in this population.

“I’ve always been optimistic that we would [reach treatment advances] at some point, but what I’m seeing today makes me excited," Bekaii-Saab said. “It’s going to make such a difference in patients’ lives. We’re on track.”