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Onco-Summaries: Daily Oncology Updates at a Glance
28/09/2026 Evorpacept demonstrates efficacy benefit in HER2-retained/high-CD47 gastric cancer subsets, in Phase 2 ASPEN-06 study; ALX will not pursue a US registrational Phase 3 study, evaluates partnership opportunities Innovent expands Phase 3 MarsLight-11 trial of IBI363/TAK-928 in NSCLC AstraZeneca invests $2B in Summit Therapeutics to advance ivonescimab-ADC combination strategy across multiple cancers Teva Receives US FDA Approval for DEGEVMA, a biosimilar to Xgeva (den

Oncofocus Team
Sep 293 min read


Onco-Summaries: Daily Oncology Updates at a Glance
15/09/2026 Ivonescimab significantly prolonged OS vs pembrolizumab in 1L PD-L1+ NSCLC in Chinese patients US FDA Fast Track Designation Granted for KST-6051 in Advanced Solid Tumors US FDA Accepts NDA for Bezuclastinib in Advanced Systemic Mastocytosis CSPC's EGFR ADC SYS6010 Receives NMPA Breakthrough Therapy Designation in NSCLC US FDA Accepts NDA for Bezuclastinib in Advanced Systemic Mastocytosis CSPC's EGFR ADC SYS6010 Receives NMPA Breakthrough Therapy Designation in NS

Oncofocus Team
Sep 174 min read


Onco-Summaries: Daily Oncology Updates at a Glance
02/09/2026 Ivonescimab demonstrated OS benefit vs pembrolizumab in PD‑L1+ NSCLC Ivonescimab demonstrated OS benefit vs pembrolizumab in PD‑L1+ NSCLC (Ref) Summit Therapeutics announced that in a Phase 3 HARMONi-2 China study, ivonescimab monotherapy demonstrated a statistically significant overall survival (OS) benefit vs pembrolizumab in PD-L1–positive advanced NSCLC patients Ivonescimab previously showed a strong progression-free survival (PFS) benefit (HR 0.51; p<0.0001) A

Oncofocus Team
Sep 41 min read


Onco-Summaries: Daily Oncology Updates at a Glance
12/08/2026 NMPA approves ivonescimab + chemo for first‑line advanced squamous NSCLC Zipalertinib Combo Achieves PFS Milestone in EGFR Exon 20 NSCLC, FDA Filing Planned NMPA approves ivonescimab + chemo for first‑line advanced squamous NSCLC (Ref) China’s NMPA approved Akeso Bio & Summit Therapeutics' ivonescimab (PD-1 x VEGF) in combination with chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC) The approval was based on the signi

Oncofocus Team
Aug 171 min read


Onco-Summaries: Daily Oncology Updates at a Glance
22/07/2026 Ivonescimab plus chemotherapy delivers consistent overall survival gains across Western and Asian NSCLC patients, reinforcing FDA‑filed Phase III HARMONi data US FDA grants Priority Review for talazoparib + enzalutamide in HRR‑mutated mCSPC, with a decision expected in Q4 2026 US FDA Accepts NDA for Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer GSK's Jideytro (zidesamtinib) Gets US FDA Approval for ROS1-Positive Lung Cancer Ivonescimab plus chemot

Oncofocus Team
Jul 233 min read


Onco-Summaries: Daily Oncology Updates at a Glance
26/08/2025 Genmab's Rina-S ADC received the Breakthrough Therapy Designation from the FDA for endometrial cancer (Ref) The US FDA granted the Breakthrough Therapy Designation to Genmab's rinatabart sesutecan (FRα-directed, TOPO1-inhibitor ADC), for the treatment of adult patients with recurrent or progressive endometrial cancer who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy. The designation was based on re

Oncofocus Team
Aug 27, 20252 min read


Onco-Summaries: Daily Oncology Updates at a Glance
28/07/2025 sNDA for Akeso and Summit's ivonescimab (PD-1 x VEGF bispecific antibody) + chemotherapy for sqNSCLC accepted by China's NMPA (Ref) The National Medical Products Administration (NMPA) has accepted the sNDA for Akeso and Summit's ivonescimab (PD-1 x VEGF bispecific antibody) + chemotherapy as a first-line treatment for advanced squamous NSCLC. The filing is based on the results from the Phase 3 AK112-306/HARMONi-6 trial, which showed that ivonescimab + chemotherapy

Oncofocus Team
Jul 28, 20253 min read


Onco-Summaries: Daily Oncology Updates at a Glance
15/07/2025 The first patient has been enrolled in the Phase 3 HARMONi-GI6 trial of ivonescimab + chemo in CRC (Ref) The first patient has been successfully enrolled in the registration Phase 3 AK112-312/HARMONi-GI6 trial of Akeso and Summit's ivonescimab (PD-1 x VEGF BsAb) in first-line treatment for advanced metastatic colorectal cancer (mCRC) The trial is evaluating ivonescimab + FOLFOXIRI vs bevacizumab + FOLFOXIRI Primary completion date: Jan'27

Oncofocus Team
Jul 18, 20251 min read


Onco-Summaries: Daily Oncology Updates at a Glance
30/06/2025 Revolution Medicines and Summit entered into a clinical collaboration to evaluate RAS(ON) inhibitors and ivonescimab combinations in RAS Mutant Tumors (Ref) Revolution Medicines and Summit Therapeutics entered into a clinical collaboration to evaluate the safety and efficacy of Revolution Medicines’ daraxonrasib (multi-selective RAS(ON) inhibitor), zoldonrasib (G12D-selective inhibitor) and elironrasib (G12C-selective inhibitor), in combination with Akeso & Summit

Oncofocus Team
Jul 1, 20252 min read


Onco-Summaries: Daily Oncology Updates at a Glance
24/04/2025 Ivonescimab Plus Chemotherapy Shows Statistically Significant Superiority Over Tislelizumab in First-Line Treatment of Squamous NSCLC (Ref 1) Akeso and Summit Therapeutics' ivonescimab, a PD-1/VEGF bispecific antibody (BsAb), in combination with chemotherapy, met its primary endpoint of progression-free survival (PFS) in the Phase 3 HARMONi-6 trial versus tislelizumab (anti-PD-1) + chemotherapy as a first-line treatment of advanced, squamous non-small cell lung can

Oncofocus Team
Apr 24, 20252 min read
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