In this week’s Oncology update regulatory milestones and late-stage clinical updates dominated, including expedited pathways, pivotal trial readouts, and filings in solid tumors. Emerging modalities and partnerships rounded out the oncology pipeline activity.
🎯 Watch Our Video Summary Capturing Oncology News from the Last Two Weeks
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📚 See the full Oncology archive on our research hub page.
Top Stories Covered in This Video
Chapters
0:00 Introduction
0:08 Sevabertinib secures dual Breakthrough Therapy Designations for first-line HER2-mutant NSCLC in the US and China
0:42 FDA clears Atossa (Z)-endoxifen IND for ER-positive, HER2-negative metastatic breast cancer trial
1:08 Curadel CPI-008 receives Orphan Drug Designation in the US and EU for pancreatic cancer surgical imaging
1:34 BREAKWATER Cohort 3: Braftovi plus cetuximab plus FOLFIRI improves ORR in BRAF V600E metastatic colorectal cancer vs standard of care
2:09 Summit submits BLA to FDA for ivonescimab plus chemotherapy in second-line and later EGFR-mutated NSCLC
2:35 FDA grants RMAT designation to Eureka ECT204, a GPC3-targeted ARTEMIS CAR T, for advanced hepatocellular carcinoma
3:04 FDA accepts Merck pimicotinib NDA for systemic treatment of tenosynovial giant cell tumor following Phase 3 MANEUVER
3:36 Tahoe–Alloy joint venture to develop first-in-class ADCs using AI-discovered tumor targets
3:59 How to reach us
Transcript
Welcome to the latest edition of Oncology Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.
Sevabertinib received Breakthrough Therapy Designation from both the FDA and China CDE for first-line treatment of locally advanced or metastatic HER2-mutant non-small cell lung cancer. The move is based on untreated cohort F from the ongoing Phase I/II SOHO-01 study, and follows a November 2025 US accelerated approval in previously treated disease. Specific endpoints for the designation were not stated.
The FDA issued a Study May Proceed letter enabling Atossa to start a clinical investigation of oral (Z)-endoxifen in ER-positive, HER2-negative metastatic breast cancer. The IND covers a selective estrogen receptor modulator or degrader with ER-targeted effects and protein kinase C inhibition, with study design details not specified here.
Curadel’s CPI-008, a zwitterionic integrin-targeted imaging agent for margin detection in pancreatic cancer surgery, received Orphan Drug Designation from both the FDA and the EMA. The status provides fee relief and potential market exclusivity, and follows prior investigator-initiated Phase 2 signals across tumor types.
In BRAF V600E metastatic colorectal cancer, the Phase 3 BREAKWATER Cohort 3 reported an objective response rate of 64 percent with Braftovi plus cetuximab plus FOLFIRI, compared with 39 percent for standard of care FOLFIRI with or without bevacizumab. ORR by blinded independent central review is the primary endpoint. Overall survival is descriptive and the trial is ongoing, with safety consistent with regimen components.
Summit Therapeutics submitted a US BLA for ivonescimab, a PD-1 and VEGF bispecific antibody, in combination with platinum doublet chemotherapy for second-line or later EGFR-mutated non-small cell lung cancer after progression on a third-generation EGFR TKI. Detailed endpoints are not reiterated here.
Eureka Therapeutics received RMAT designation for ECT204, an autologous GPC3-targeted ARTEMIS CAR T using an AbTCR architecture, for advanced hepatocellular carcinoma. The decision reflects data from a Phase I cohort and additional ARYA-3 results. RMAT enables enhanced FDA interactions and potential accelerated pathways.
Merck’s pimicotinib, an oral CSF-1R inhibitor, had its NDA accepted by the FDA for systemic treatment of tenosynovial giant cell tumor. The Phase 3 MANEUVER trial showed significant ORR by blinded independent central review at week 25 and improvements in patient-reported outcomes, with responses increasing over longer follow-up. China approved the drug in December 2025.
Tahoe–Alloy launched a joint venture to develop first-in-class antibody–drug conjugates targeting Mosaic-identified and validated tumor antigens. Two ADC programs will be advanced with support from 82VS, pairing AI-powered target discovery with integrated ADC engineering to reach key inflection points.
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Why it matters
- HER2-mutant NSCLC could gain an oral first-line TKI option if sevabertinib confirms benefit.
- BRAF V600E mCRC may see broader chemo-backbone flexibility with BRAFTOVI regimens.
- TGCT patients gain a potential systemic option with meaningful symptom outcomes.
- RMAT status spotlights momentum for cell therapy in solid tumors.
- AI-enabled target discovery continues to seed next-gen ADC pipelines.
🗓️ Explore more details and sources
📚 See the full Oncology archive on our research hub page.
FAQ
What did regulators grant for sevabertinib?
FDA and China’s CDE granted Breakthrough Therapy Designation for first-line treatment of HER2-mutant NSCLC, supported by preliminary SOHO-01 cohort F data, following US accelerated approval in previously treated disease [1].
Is Atossa’s (Z)-Endoxifen trial cleared to start?
Yes. FDA issued a “Study May Proceed” letter for a metastatic ER+/HER2- breast cancer study under a recent IND. Specific design details were not disclosed in the release [2].
What protections did CPI-008 receive?
Curadel’s integrin-targeted, zwitterionic imaging agent for pancreatic cancer received Orphan Drug Designation from both FDA and EMA, conferring development incentives and potential market exclusivity if approved [3].
How did the BRAFTOVI+cetuximab+FOLFIRI arm perform in BREAKWATER?
Cohort 3 showed significantly higher confirmed ORR by BICR versus SOC FOLFIRI±bevacizumab. OS data were descriptive with ~10 months’ follow-up; the trial continues [4].
What is Summit seeking with ivonescimab?
A US BLA for ivonescimab plus chemotherapy in 2L+ EGFR-mutated NSCLC after 3rd-gen EGFR TKI progression, based on Phase 3 HARMONi results (endpoint details not restated here) [5].
What does RMAT mean for ECT204?
RMAT designation enables enhanced FDA dialogue, potential use of surrogate endpoints, and priority review eligibility for the GPC3-targeted ARTEMIS CAR T in advanced HCC [6].
Entities / Keywords
Sevabertinib (Bayer; HER2/EGFR TKI) • Hyrnuo • SOHO-01 • HER2-mutant NSCLC
(Z)-Endoxifen (Atossa; SERM/D) • ER+/HER2- mBC
CPI-008 / cRGD-ZW800-1 (Curadel; integrin-targeted surgical imaging) • Pancreatic cancer
BRAFTOVI (encorafenib; Pfizer) • Cetuximab • FOLFIRI • BREAKWATER • BRAF V600E mCRC
Ivonescimab/SMT112/AK112 (Summit/Akeso; PD-1/VEGF bispecific) • HARMONi
ECT204 (Eureka; GPC3 ARTEMIS CAR T, AbTCR) • ARYA-3 • HCC
Pimicotinib/ABSK021 (Merck KGaA; CSF-1R inhibitor) • MANEUVER • TGCT
Tahoe Therapeutics • Alloy Therapeutics • 82VS • ADCs • Mosaic platform • AI-powered target discovery
References