Oncology Update : Ozuriftamab Phase 3, Libtayo 5-Year Data, INLEXZO Approval and More
From FDA-aligned Phase 3 designs and AI-driven therapy prediction to five-year survival benefits, bispecific breakthroughs, presurgical TNBC milestones, and tumor-agnostic HER2 applications—this roundup spans lung, breast, pancreatic, colorectal, ovarian, bladder, and HER2-positive cancers driving oncology forward.
In Today’s Newsletter
🎯 Ozuriftamab vedotin Phase 3 regulatory alignment [1] [US • 08 Sep 2025]
Key point: FDA Type B (EOP2) meeting confirmed Phase 3 design (~300 OPSCC pts; Oz-V vs cetuximab/docetaxel/methotrexate). Accelerated approval: ORR (BICR); full approval: OS.
Context: Prior Phase 2 in HPV+ OPSCC showed 45% ORR (confirmed/unconfirmed) and ongoing mOS of 11.6 mo.
Implication: Signals pipeline investment and modality expansion.
🧠 Cellworks ΔTRI chemo-IO prediction in NSCLC [2] [EU • 08 Sep 2025]
Key point: In validation cohort (n=328), 22% “high-benefit” pts had OS gain with chemo-IO; 78% saw no added benefit.
Context: Computational biosimulation using NGS; PD-L1-independent; presented at WCLC 2025.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🫁 Libtayo + chemotherapy: 5-yr EMPOWER-Lung 3 update [3] [US • 09 Sep 2025]
Key point: 1L NSCLC: median OS 21.1 vs 12.9 mo (HR 0.66); 5-yr survival 19.4% vs 8.8%; PFS HR 0.58.
Context: n=466; broad histologies and PD-L1 levels; safety consistent with prior.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Pumitamig Phase 2 interim in ES-SCLC [4] [08 Sep 2025]
Key point: cORR 76.3% (n=38 evaluable), DCR 100%, mPFS 6.8 mo; OS immature; manageable safety.
Context: PD-L1×VEGF-A bispecific + chemo; Phase 3 ROSETTA-LUNG-01 underway.
Implication: May influence prescriber choice and payer reviews pending full data.
🧷 INT230-6 presurgical TNBC (INVINCIBLE-4) update [5] [US • 10 Sep 2025]
Key point: First evaluated patient achieved pCR; trial paused to address skin irritation (company decision).
Context: Phase 2, two INT230-6 doses pre-SOC immunochemotherapy; endpoint pCR; sites in CH/FR.
Implication: May influence prescriber choice and payer reviews pending full data.
🔬 Daraxonrasib clinical update in PDAC [6] [US • 10 Sep 2025]
https://firstwordpharma.com/story/6061082
Key point: In 2L PDAC, ORR 29–35%, mPFS ~8 mo, mOS 13–15 mo. In 1L PDAC, ORR 47% monotherapy; 55% combo with GnP.
Context: Oral RAS(ON) multi-selective inhibitor; Phase 3 RASolute 303 to start Q4 2025 (monotherapy, combo vs GnP).
Implication: May influence prescriber choice and payer reviews pending full data.
🇫🇷 BOT/BAL compassionate access in MSS mCRC [7] [EU • 09 Sep 2025]
Key point: ANSM AAC authorization enables reimbursed BOT/BAL use in refractory MSS mCRC without active liver metastases.
Context: Supported by Phase 1/2 data (~21-mo OS; ~20% ORR in select pts); Phase 3 BATTMAN trial planned.
Implication: May expand screening, initiation, and follow-up at scale.
🧪 Relacorilant NDA filed in platinum-resistant ovarian cancer [8] [US • 10 Sep 2025]
Key point: FDA accepted NDA; PDUFA 11 Jul 2026. Based on Phase 3 ROSELLA + Phase 2 showing PFS/OS improvement with relacorilant + nab-paclitaxel vs chemo.
Context: Oral selective GR antagonist; no biomarker selection; safety consistent with known profile.
Implication: May influence prescriber choice and payer reviews pending full data.
💊 INLEXZO (gemcitabine intravesical system) FDA approval [9] [US • 09 Sep 2025]
Key point: FDA approved INLEXZO™ for BCG-unresponsive NMIBC with CIS (± papillary tumors); 82% CR, 51% durable ≥1 yr.
Context: First intravesical drug-releasing system; placed outpatient, remains 3 wks per cycle.
Implication: May influence prescriber choice and payer reviews pending full data.
🧷 ENHERTU tumor-agnostic EU application validated [10] [EU • 11 Sep 2025]
https://www.daiichisankyo.com/files/news/pressrelease/pdf/202509/20250911_E.pdf
Key point: EMA validated application for HER2+ (IHC 3+) metastatic solid tumors post-therapy; tumor-agnostic.
Context: Based on DESTINY-PanTumor02/CRC02/Lung01 showing clinically meaningful responses across tumor types.
Implication: Introduces competition that may affect pricing and formulary access.
Why it matters
- Regulatory momentum (Oz-V, relacorilant, ENHERTU) defines 2025–26 oncology cycle.
- AI-based therapy prediction (Cellworks) aims to refine chemo-IO patient selection.
- Long-term survival data (Libtayo) and high ORRs (pumitamig, daraxonrasib) reinforce checkpoint + targeted therapy roles.
- Access innovations (France AAC for BOT/BAL, INLEXZO approval) expand options in high-unmet settings.
- Early-phase intratumoral (INT230-6) continues to probe presurgical TNBC opportunities.
📢 Stay Ahead in Oncology Research!
✅ Contact LucidQuest at info@lqventures.com for strategic guidance on oncology innovations and clinical research.
FAQ
What endpoints define BioAtla’s Oz-V Phase 3?
AA: confirmed ORR (BICR) with DOR; full approval: OS. ~300 HPV+ OPSCC pts, Oz-V 1.8 mg/kg Q2W vs investigator’s choice [1].
How does Cellworks’ ΔTRI improve on PD-L1?
It predicts chemo-IO benefit independent of PD-L1, identifying 22% “high-benefit” pts vs 78% with no added benefit [2].
What is the durability of Libtayo + chemo?
At 5 yrs, OS HR 0.66; survival 19.4% vs 8.8%; benefits across histologies and PD-L1 groups [3].
What are pumitamig’s Phase 2 signals?
76.3% cORR, 100% DCR, mPFS 6.8 mo in ES-SCLC; OS immature; Phase 3 ongoing [4].
What did Revolution’s daraxonrasib show?
2L PDAC ORR ~29–35%; 1L monotherapy ORR 47%; combo with GnP ORR 55%. Phase 3 RASolute 303 starts Q4 2025 [6].
What access has Agenus BOT/BAL gained?
France AAC reimbursed hospital use for refractory MSS mCRC (no active liver mets); Phase 3 BATTMAN due Q4 2025 [7].
Entities / Keywords
BioAtla; Ozuriftamab vedotin; ROR2-ADC; OPSCC
Cellworks; ΔTRI; chemo-IO prediction; NSCLC
Regeneron; Libtayo; cemiplimab; EMPOWER-Lung 3; NSCLC
BioNTech; BMS; pumitamig; PD-L1×VEGF-A; ES-SCLC
Intensity Therapeutics; INT230-6; presurgical TNBC; pCR
Revolution Medicines; Daraxonrasib; PDAC; RASolute trials
Agenus; botensilimab; balstilimab; MSS mCRC; France AAC
Corcept; Relacorilant; GR antagonist; ovarian cancer
Johnson & Johnson; INLEXZO; gemcitabine intravesical; NMIBC
Daiichi Sankyo; AstraZeneca; ENHERTU; HER2+ tumor-agnostic; EMA
References
- https://ir.bioatla.com/news-releases/news-release-details/bioatla-announces-regulatory-update-clinical-development-plan
- https://cellworks.life/news-events/press-releases/cellworks-unveils-breakthrough-predicting-chemo-immunotherapy-benefit
- https://investor.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-plus-chemotherapy-results-five-years
- https://news.bms.com/news/corporate-financial/2025/First-Disclosure-of-Global-Interim-Phase-2-Data-for-BioNTech-and-Bristol-Myers-Squibb-PD-L1xVEGF-A-Bispecific-Antibody-Pumitamig-BNT327-BMS986545-in-Patients-with-Extensive-Stage-Small-Cell-Lung-Cancer-Shows-Encouraging-Antitumor-Activity/default.aspx
- https://ir.intensitytherapeutics.com/news-events/press-releases/detail/111/intensity-therapeutics-reports-invincible-4-presurgical
- https://firstwordpharma.com/story/6061082
- https://investor.agenusbio.com/news/news-details/2025/France-Grants-Reimbursed-Compassionate-Access-AAC-for-Agenus-BOTBAL-in-Refractory-MSS-Metastatic-Colorectal-Cancer/default.aspx
- https://ir.corcept.com/news-releases/news-release-details/fda-files-corcepts-new-drug-application-relacorilant-treatment-0
- https://www.jnj.com/media-center/press-releases/u-s-fda-approval-of-inlexzo-gemcitabine-intravesical-system-set-to-transform-how-certain-bladder-cancers-are-treated
- https://www.daiichisankyo.com/files/news/pressrelease/pdf/202509/20250911_E.pdf