Oncology Today—March 9, 2026

This week’s Oncology update highlights regulatory approvals, reimbursement expansion, new clinical trial launches, biomarker validation progress, and multiple collaborations advancing targeted and immunotherapy pipelines.

In Today’s Newsletter

Dive deeper

💊 Incyte wins EU approval for Zynyz in advanced SCAC [1] [EU • 06 Mar 2026]

https://investor.incyte.com/news-releases/news-release-details/incyte-announces-european-commission-approval-zynyzr
Context: POD1UM-303/InterAACT2 evaluated retifanlimab plus carboplatin and paclitaxel in metastatic or inoperable locally recurrent SCAC.
Key point: European Commission approved Zynyz (retifanlimab, Incyte; PD-1 antibody) with chemotherapy for first-line advanced SCAC; source cites improved PFS and secondary efficacy endpoints, including OS.
Implication: May influence prescriber choice and payer reviews pending full data.

🧠 Akeso and INOVIO pair cadonilimab with INO-5412 in GBM [2] [04 Mar 2026]

https://akesobio.com/en/media/akeso-news/260305/
Context: The combination will be studied in INSIGhT, a Phase II adaptive platform trial in glioblastoma sponsored by Dana-Farber Cancer Institute.
Key point: Akeso (cadonilimab; PD-1/CTLA-4 bispecific) and INOVIO (INO-5412; DNA immunotherapy) signed a clinical collaboration and supply agreement for GBM; dosing is expected in H2 2026.
Implication: Signals pipeline investment and modality expansion.

🇯🇵 Novocure secures Japan reimbursement for Optune Lua in NSCLC [3] [Japan • 02 Mar 2026]

https://www.novocure.com/novocure-announces-optune-luar-receives-reimbursement-approval-japan-treatment-non-small-cell-lung
Context: Optune Lua is approved in Japan for concurrent use with PD-1/PD-L1 inhibitors in adult patients with unresectable advanced or recurrent NSCLC after platinum-based chemotherapy.
Key point: Japan’s Ministry of Health, Labour and Welfare approved national reimbursement coverage for Optune Lua (Novocure; TTFields device).
Implication: May expand screening, initiation, and follow-up at scale.

☢️ ITM reports pancreatic NET subgroup data from Phase 3 COMPETE [4] [EU • 05 Mar 2026]

https://www.itm-radiopharma.com/news/press-releases/press-releases-detail/itm-announces-phase-3-compete-trial-post-hoc-subgroup-analyses-with-n-c-a-177lu-edotreotide-itm-11-in-patients-with-pancreatic-neuroendocrine-tumors-at-enets-2026-conference-751/
Context: COMPETE compared 177Lu-edotreotide (ITM-11) with everolimus in Grade 1 or Grade 2, SSTR-positive GEP-NETs; these results are a post-hoc pancreatic NET subgroup analysis.
Key point: In pancreatic NETs, ITM reported median PFS of 24.5 months versus 14.7 months and ORR of 33.3% versus 3.6% for 177Lu-edotreotide versus everolimus.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 AIM starts Phase 3 planning for Ampligen in late-stage pancreatic cancer [5] [US • 02 Mar 2026]

https://aimimmuno.com/aim-immunotech-signs-agreement-for-planning-of-a-proposed-phase-3-clinical-trial-of-ampligen-in-the-treatment-of-late-stage-pancreatic-cancer/
Context: AIM signed with Thermo Fisher’s PPD clinical research business to design a proposed Phase 3 study; company cites ongoing Phase 2 DURIPANC work with durvalumab.
Key point: AIM ImmunoTech moved Ampligen (rintatolimod) into formal Phase 3 planning for late-stage pancreatic cancer, based on company-described encouraging interim Phase 2 progress.
Implication: Signals pipeline investment and modality expansion.

🩸 Hepion adds ctRNA liquid-biopsy assay for HCC surveillance [6] [US • 03 Mar 2026]

https://hepionpharma.com/news/hepion-pharmaceuticals-in-licenses-ctrna-biomarker-assay-to-facilitate-early-diagnosis-and-surveillance-of-hepatocellular-carcinoma/
Context: Hepion licensed the assay from Cirna Diagnostics and said it complements its mSEPT9 methylated DNA test for liver cancer.
Key point: Hepion in-licensed a blood-based ctRNA biomarker assay for early diagnosis and surveillance of hepatocellular carcinoma in high-risk patients.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

💶 Theolytics lands Horizon Europe funding for THEO-260 ovarian study [7] [EU • 04 Mar 2026]

https://www.theolytics.com/post/theolytics-awarded-8-million-in-horizon-europe-2025-grant-funding-to-advance-phase-2-study-of-theo
Context: Funding is pending final negotiation and is tied to OCTOPOD-IV, a Phase 2a expansion study of THEO-260 in platinum-resistant ovarian cancer.
Key point: Theolytics received a pending €8 million Horizon Europe 2025 award to support clinical and translational work around THEO-260, including up to 20 patients in the expansion cohort.
Implication: Signals pipeline investment and modality expansion.

🎯 Kestrel clears IND for pan-KRAS inhibitor KST-6051 [8] [US • 05 Mar 2026]

https://kestreltherapeutics.com/wp-content/uploads/2026/03/FDA-Approves-KST-6051.pdf
Context: KST-6051 is an oral pan-KRAS inhibitor intended for KRAS-mutant solid tumors; the planned FALCON Phase 1 will study safety, tolerability, and preliminary anti-tumor activity.
Key point: Kestrel said the U.S. FDA cleared the IND for KST-6051, enabling a first-in-human Phase 1 dose-escalation trial in advanced or metastatic KRAS-mutant solid tumors.
Implication: Signals pipeline investment and modality expansion.

🔬 BBOT publishes preclinical pan-KRAS data for BBO-11818 [9] [US • 06 Mar 2026]

https://investors.bbotx.com/news-releases/news-release-details/bbot-announces-publication-cancer-discovery-highlighting
Context: BBOT’s Cancer Discovery paper describes BBO-11818 as a non-covalent inhibitor of KRAS in both ON and OFF states; the agent is also in the Phase 1 KONQUER-101 trial.
Key point: BBOT reported publication of preclinical data for BBO-11818 and reiterated early Phase 1 monotherapy activity, including a confirmed partial response in PDAC.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 Adela validates tissue-free immunotherapy monitoring test in solid tumors [10] [US • 03 Mar 2026]

https://www.adelabio.com/press/adela-announces-study-published-in-npj-precision-oncology-clinically-validating-its-tissue-free-test-to-monitor-immunotherapy-response-in-advanced-solid-tumors
Context: The npj Precision Oncology study used banked samples from 64 patients with advanced solid tumors who received pembrolizumab in the INSPIRE study.
Key point: Adela reported clinical validation showing that a decrease in methylated ctDNA from baseline to pre-cycle 3 was associated with higher response, greater clinical benefit, and better survival outcomes.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧫 HUTCHMED starts global Phase I/IIa trial for HMPL-A580 [11] [04 Mar 2026]

https://www.hutch-med.com/a580-global-phase-i/
Context: HMPL-A580 is an EGFR-targeted antibody-targeted therapy conjugate carrying a PI3K/PIKK inhibitor payload; first patient was dosed on 04 Mar 2026.
Key point: HUTCHMED initiated a Phase I/IIa study of HMPL-A580 in unresectable, advanced or metastatic solid tumors across China and the US.
Implication: Signals pipeline investment and modality expansion.

Why it matters

Oncology development this week spanned regulation, reimbursement, clinical readouts, platform funding, and biomarker validation, showing breadth rather than a single dominant theme. [1][3][4][7][10]
KRAS remains a crowded but active battleground, with Kestrel moving KST-6051 into the clinic and BBOT pushing a pan-KRAS story from discovery to early human data. [8][9]
Biomarker and liquid-biopsy companies continue to move closer to real-world deployment, especially where tissue-free monitoring or surveillance may solve access gaps. [6][10]
Partnership and platform stories remain important signals for investors and developers, especially in GBM, ovarian cancer, and targeted conjugate platforms. [2][7][11]
Commercial access still matters as much as data generation, highlighted by Zynyz’s EU approval and Optune Lua’s reimbursement step in Japan. [1][3]

🚀 Accelerate your success. Contact us now

📂 Explore our case studies. See examples of our work.

💡 Read our insights. Learn from our latest reports and analysis

🎬 Watch on YouTube. Subscribe and never miss a video.

🧰 See our full range of services. Discover how we can help you.

Discover the full Oncology archive on our research hub page.

FAQ

What changed for Zynyz in Europe this week?

The European Commission approved Zynyz (retifanlimab) plus carboplatin and paclitaxel for first-line treatment of metastatic or inoperable locally recurrent SCAC. Incyte tied the decision to Phase 3 POD1UM-303 results. [1]

What is the Akeso–INOVIO GBM collaboration actually testing?

It combines cadonilimab, Akeso’s PD-1/CTLA-4 bispecific antibody, with INO-5412, INOVIO’s DNA immunotherapy, in the INSIGhT Phase II adaptive platform trial for glioblastoma. Dosing is expected in H2 2026. [2]

Why is Novocure’s Japan update important if Optune Lua was already approved?

This step is about reimbursement, not first approval. National Health Insurance coverage can materially affect access and real-world uptake for eligible NSCLC patients in Japan. [3]

What did ITM show in pancreatic NETs?

In a post-hoc subgroup from the Phase 3 COMPETE study, ITM reported longer median PFS and higher ORR for 177Lu-edotreotide versus everolimus in pancreatic NET patients. OS data were described as immature. [4]

How far along are the pan-KRAS programs from Kestrel and BBOT?

Kestrel’s KST-6051 just cleared IND and is entering first-in-human Phase 1 testing. BBOT’s BBO-11818 has a new Cancer Discovery preclinical paper and is already in Phase 1, with additional data expected in H2 2026. [8][9]

What is distinctive about Adela’s immunotherapy monitoring test?

Adela positions it as tissue-free and methylation-based, using blood draws rather than tumor tissue. In the published validation study, early decreases in methylated ctDNA tracked with better response and survival outcomes. [10]

Entities / Keywords

Incyte, Zynyz, retifanlimab, POD1UM-303, InterAACT2, SCAC, anal canal squamous cell carcinoma, PD-1 [1]
Akeso, cadonilimab, PD-1/CTLA-4 bispecific, INOVIO, INO-5412, INO-5401, INO-9012, INSIGhT, glioblastoma, GBM [2]
Novocure, Optune Lua, TTFields, Tumor Treating Fields, NSCLC, Japan reimbursement [3]
ITM, 177Lu-edotreotide, ITM-11, COMPETE, GEP-NET, pancreatic NET, P-NET, everolimus [4]
AIM ImmunoTech, Ampligen, rintatolimod, DURIPANC, durvalumab, pancreatic cancer [5]
Hepion Pharmaceuticals, ctRNA, Cirna Diagnostics, mSEPT9, HCC, hepatocellular carcinoma, liquid biopsy [6]
Theolytics, THEO-260, OCTOPOD-IV, platinum-resistant ovarian cancer, Horizon Europe [7]
Kestrel Therapeutics, KST-6051, pan-KRAS, FALCON, KRAS-mutant solid tumors [8]
BBOT, BBO-11818, KONQUER-101, panKRAS, KRAS ON/OFF, BBO-10203 [9]
Adela, methylated ctDNA, tissue-free test, immunotherapy response monitoring, npj Precision Oncology, INSPIRE [10]
HUTCHMED, HMPL-A580, ATTC, PI3K/PIKK, EGFR, Phase I/IIa [11]