Onco-Summaries: Daily Oncology Updates at a Glance

10/11/2025

Boehringer Ingelheim's zongertinib received the Commissioner’s National Priority Voucher for HER2-mutant NSCLC (Ref)

The US FDA awarded a Commissioner’s National Priority Voucher (CNPV) to Boehringer Ingelheim's zongertinib (HER2 TKI) for the treatment of patients with HER2-mutant NSCLC. 

• Boehringer Ingelheim is planning a sNDA for zongertinib in the first-line treatment of patients with HER2-mutant NSCLC

• Previously, zongertinib received accelerated approval by the FDA for previously treated patients with HER2-mutant advanced NSCLC

Avenzo Therapeutics and Duality Biotherapeutics' AVZO-1418/DB-1418 received the FDA fast track designation for EGFRm NSCLC (Ref)

The US FDA granted the fast track designation to Avenzo Therapeutics and Duality Biotherapeutics' AVZO-1418/DB-1418 (EGFR x HER3 bispecific ADC) for the treatment of patients with unresectable, locally advanced, or metastatic NSCLC with an EGFR exon 19 deletion or exon 21 L858R mutation, whose disease has progressed on or after therapy with an EGFR TKI. (Ref)

• Mohammad Hirmand, Co-founder and CMO, Avenzo Therapeutics: “We are excited to receive this Fast Track designation from the FDA, underscoring the promise of AVZO-1418, especially for patients with EGFR-Mutated TKI-Pretreated NSCLC. This designation has the potential to help expedite the development of AVZO-1418, which we continue to rapidly advance in Phase 1.”

• AVZO-1418 is currently being studied in a Phase 1/2 trial evaluating the safety, tolerability, and preliminary clinical activity of AVZO-1418 as a single agent and in combination therapy in patients with advanced solid tumors

• To note, in Jan'25, Avenzo Therapeutics and Duality Biotherapeutics entered into an exclusive license agreement, pursuant to which Avenzo will develop, manufacture and commercialize AVZO-1418/DB-1418, a potential best-in-class EGFR/HER3 bispecific ADC, globally (excluding Greater China)

The Phase 3 PEAK trial of Cogent's bezuclastinib + sunitinib met the primary endpoint of PFS in GIST (Ref) 

In the Phase 3 PEAK trial, Cogent Biosciences' bezuclastinib (KIT inhibitor) + sunitinib met the primary endpoint of PFS in patients with imatinib-resistant or intolerant Gastrointestinal Stromal Tumors (GIST)

• The combo elicited a mPFS of 16.5 mos vs 9.2 mos in the sunitinib monotherapy arm (HR=0.50, CI: 0.39-0.65; p<0.0001)

• Additionally, the ORR was 46% vs 26% (p<0.0001)

• Cogent plans to present detailed results at an upcoming scientific conference, and is on track to submit an NDA to the US FDA for the regimen in GIST in H1'26

Purdue Pharma's tinostamustine received the FDA orphan drug designation for malignant gliomas (Ref)

The US FDA granted the orphan drug designation to Purdue Pharma's tinostamustine (HDAC inhibitor) for the treatment of malignant gliomas.

• Purdue is currently investigating tinostamustine in patients with glioblastoma

• Julie Ducharme, Vice President and CSO, Purdue: "As many as 15,000 people in the U.S. are diagnosed with glioblastoma each year. Unfortunately, there is limited survival benefit with existing treatment options. This recognition from FDA is an important milestone in our mission of advancing innovative science in areas of serious, unmet medical need. We look forward to further investigating tinostamustine, which has shown promise in early trials."