Onco-Summaries: Daily Oncology Updates at a Glance

09/06/2026

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• Imugene’s Azer-cel secures FDA Fast Track for CLL/SLL and MZL

• FDA grants RedHill’s opaganib Rare Pediatric Disease designation for neuroblastoma

• Serplulimab secures world‑first approval as a chemo‑sparing perioperative immunotherapy for gastric cancer

• FDA grants RMAT to lasme‑cel, advancing the first off‑the‑shelf CAR‑T into pivotal r/r B‑ALL trial

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Imugene’s Azer-cel secures FDA Fast Track for CLL/SLL and MZL (Ref)

Imugene's Azer-cel (azercabtagene zapreleucel; CD19-directed allogeneic CAR T-cell therapy) received Fast Track status for relapsed/refractory Chronic Lymphocytic Leukaemia / Small Lymphocytic Lymphoma (CLL/SLL) and Marginal Zone Lymphoma (MZL)

Clinical Data:

• CLL/SLL: Phase 1b basket study showed 100% overall response rate (ORR) in CAR T-naive patients (median ≥3 prior therapies).

• MZL: Updated Phase 1b data showed 83% ORR, including four complete responses out of six evaluable patients (median ≥2 prior therapies)

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FDA grants RedHill’s opaganib Rare Pediatric Disease designation for neuroblastoma (Ref)

RedHill's Opaganib (SPHK2 selective inhibitor) received Rare Pediatric Disease (RPD) designation for neuroblastoma, in addition to its existing Orphan Drug designation

RPD designation provides eligibility for a Priority Review Voucher (PRV), while orphan drug status offers potential seven years’ marketing exclusivity, accelerated review, PDUFA fee waivers, and tax credits if approved

Clinical Development:

• Ongoing Phase 2 trial with Bayer’s darolutamide in metastatic castrate-resistant prostate cancer.

• Phase 1 chemoradiotherapy study protocol ready for FDA submission

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Serplulimab secures world‑first approval as a chemo‑sparing perioperative immunotherapy for gastric cancer (Ref)

Henlius' anti-PD-1 antibody serplulimab (HANSIZHUANG) has been approved by China's NMPA for perioperative treatment of PD-L1-positive resectable gastric cancer, becoming the world's first and only anti-PD-1 mAb approved for this indication

The pivotal Phase 3 ASTRUM-006 study (588 patients) showed a 33% reduction in risk of disease progression/recurrence/death (EFS) vs. chemotherapy control, a pathological complete response (pCR) rate of 21.6% (3x the control group), and an R0 resection rate of 96.7%

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FDA grants RMAT to lasme‑cel, advancing the first off‑the‑shelf CAR‑T into pivotal r/r B‑ALL trial (Ref)

The US FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Cellectis' lasmecabtagene timgedleucel (lasme‑cel), CD22‑targeting allogeneic CAR‑T candidate for relapsed/refractory B‑cell acute lymphoblastic leukemia (r/r B‑ALL)

This is the first allogeneic CAR‑T therapy in a pivotal trial for r/r B‑ALL, highlighting FDA recognition of its potential to address unmet need

• The pivotal Phase 2 BALLI‑01/NCT04150497 trial is now open for enrollment

The designation is backed by Phase 1 part of the BALLI‑01 trial results, which showed promising efficacy and a manageable safety profile

• Final Phase 1 data will be presented at the 2026 European Hematology Association (EHA) Congress on June 13 by Dr. Nitin Jain of MD Anderson

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