Onco-Summaries: Daily Oncology Updates at a Glance
Updated: 2 days ago
15/09/2026
Ivonescimab significantly prolonged OS vs pembrolizumab in 1L PD-L1+ NSCLC in Chinese patients (Ref1, Ref2)
Outcomes from the second interim analysis of the China-specific Ph3 HARMONi-2 trial presented at WCLC'26 showed that Akeso Bio & Summit Therapeutiic's ivonescimab (PD-1 x VEGF BsAb) monotherapy significantly prolonged OS vs pembrolizumab mono in Tx-naive PD-L1+ (TPS ≥1%) LA/M pts (abstract #OA14.01 Ref1, Ref2)
For this OS analysis, a prespecified O'Brien-Fleming spending function was used, with a one-sided alpha of 0.0141. At mFU of 36.0 mos, in the ITT population, pts in the ivonescimab arm (n=198) had a median OS of 30.8 mos vs 22.6 mos in the pembro arm (n=200) with OS HR 0.73 (95% CI 0.57-0.95; P=0.009). OS benefit was consistent across subgroups, with highest benefits seen in squamous (OS HR 0.65; 95% CI 0.45-0.95) and PD-L1≥50% (OS HR 0.58; 95% CI 0.38-0.89) subgroups.
While OS data from the HARMONi-2 trial helps instill confidence in the ivonescimab regimen, data from the global Ph3 HARMONi-3 (ivone + chemo vs pembro + chemo; 1L PD-L1 unselected pts; initial data expected in H2'26/H1'27) and HARMONi-7 (ivone mono vs pembro mono; PD-L1≥50% pts) trials would decide whether ivonescimab replaces pembro as the SOC in 1L pts
US FDA Fast Track Designation Granted for KST-6051 in Advanced Solid Tumors (Ref)
Kestrel Therapeutics announced that KST-6051 (oral pan-KRAS inhibitor) has received US FDA Fast Track designation for advanced or metastatic solid tumors harboring KRAS mutations
KST-6051 is currently in a Phase 1 dose-escalation FALCON/NCT07458347 study in patients with advanced or metastatic KRAS-mutant solid tumors
US FDA Accepts NDA for Bezuclastinib in Advanced Systemic Mastocytosis (Ref)
Cogent Biosciences announced that the US FDA has accepted its NDA for bezuclastinib (KIT D816V tyrosine kinase inhibitor) in the treatment of patients with Advanced Systemic Mastocytosis (AdvSM)
PDUFA target action date of June 29, 2027 has been assigned
The FDA currently does not plan to convene an Advisory Committee meeting and has not identified any potential review issues at this stage
The application is supported by data from the pivotal APEX trial, which demonstrated:
65% overall response rate (ORR) by mIWG-MRT-ECNM criteria
57% CR/CRh/PR rate as best response
81% response rate by pure pathological response criteria
79% 12-month progression-free survival (PFS)
87% 12-month overall survival (OS)
Median PFS and OS were not mature at analysis
CSPC's EGFR ADC SYS6010 Receives NMPA Breakthrough Therapy Designation in NSCLC (Ref)
CSPC Pharmaceutical announced that its EGFR-targeting ADC, SYS6010, has been granted Breakthrough Therapy Designation (BTD) by China's NMPA for the treatment of recurrent or metastatic actionable genomic alteration-negative non-squamous NSCLC in patients who have progressed following immunotherapy and platinum-based chemotherapy
The designation was supported by clinical data demonstrating a significantly improved objective response rate (ORR), durable responses, and progression-free survival (PFS) exceeding two times that of standard treatment
A randomized, open-label, multicenter Phase III study is currently ongoing in patients with actionable genomic alteration-negative locally advanced or metastatic non-squamous NSCLC who have failed standard therapies
This marks the fourth NMPA Breakthrough Therapy Designation for SYS6010, reflecting the program's expanding clinical potential across multiple tumor types.
Previous BTDs were granted in EGFR-mutant NSCLC after EGFR-TKI and platinum chemotherapy failure, esophageal squamous cell carcinoma (ESCC), and recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)
US FDA Accepts NDA for Bezuclastinib in Advanced Systemic Mastocytosis (Ref)
Cogent Biosciences announced that the US FDA has accepted its NDA for bezuclastinib (KIT D816V tyrosine kinase inhibitor) in the treatment of patients with Advanced Systemic Mastocytosis (AdvSM)
PDUFA target action date of June 29, 2027 has been assigned
The FDA currently does not plan to convene an Advisory Committee meeting and has not identified any potential review issues at this stage
The application is supported by data from the pivotal APEX trial, which demonstrated:
65% overall response rate (ORR) by mIWG-MRT-ECNM criteria
57% CR/CRh/PR rate as best response
81% response rate by pure pathological response criteria
79% 12-month progression-free survival (PFS)
87% 12-month overall survival (OS)
Median PFS and OS were not mature at analysis
CSPC's EGFR ADC SYS6010 Receives NMPA Breakthrough Therapy Designation in NSCLC (Ref)
CSPC Pharmaceutical announced that its EGFR-targeting ADC, SYS6010, has been granted Breakthrough Therapy Designation (BTD) by China's NMPA for the treatment of recurrent or metastatic actionable genomic alteration-negative non-squamous NSCLC in patients who have progressed following immunotherapy and platinum-based chemotherapy
The designation was supported by clinical data demonstrating a significantly improved objective response rate (ORR), durable responses, and progression-free survival (PFS) exceeding two times that of standard treatment
A randomized, open-label, multicenter Phase III study is currently ongoing in patients with actionable genomic alteration-negative locally advanced or metastatic non-squamous NSCLC who have failed standard therapies
This marks the fourth NMPA Breakthrough Therapy Designation for SYS6010, reflecting the program's expanding clinical potential across multiple tumor types.
Previous BTDs were granted in EGFR-mutant NSCLC after EGFR-TKI and platinum chemotherapy failure, esophageal squamous cell carcinoma (ESCC), and recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)
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