Oncology Today—March 16, 2026

This week’s Oncology update highlights regulatory progress, pivotal-intent trial starts, early clinical signals, financing activity, IP expansion, and ongoing momentum across solid tumor development.

In Today’s Newsletter

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🧠 Aminex wins second orphan designation for AMXT 1501 in glioma [1] [US • 12 Mar 2026]

https://aminextx.com/wp-content/uploads/2026/03/FINAL-Aminex-ODD-glioma-PR-for-3_11_26-Rathbun-Communications.pdf
Context: AMXT 1501 (Aminex Therapeutics; polyamine transport inhibitor) plus DFMO received FDA orphan drug designation for malignant glioma, including DIPG.
Key point: Aminex said this is its second FDA orphan designation, after neuroblastoma in Oct 2025, and noted active pediatric Phase 1/2 and adult Phase 1b/2 studies.
Implication: May influence prescriber choice and payer reviews pending full data.

🫁 Henlius starts pivotal-intent HLX43 study in sqNSCLC [2] [US • 12 Mar 2026]

https://www.henlius.com/en/NewsDetails-5785-26.html
Context: HLX43 (Henlius; PD-L1 ADC) entered a randomized global Phase 2/3 trial in advanced or metastatic sqNSCLC after prior therapy, with HLX43 alone or plus HLX07 versus docetaxel.
Key point: Henlius said Stage 3 could become the first pivotal registration study for HLX43, with OS and PFS as dual primary endpoints and about 566 patients planned in Phase 3.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 Oryzon broadens iadademstat IP in Mexico [3] [US • 12 Mar 2026]

https://www.oryzon.com/en/news-events/news/oryzon-expands-patent-protection-iadademstat-grant-decision-mexico-covering
Context: Oryzon Genomics said Mexico issued a grant decision covering iadademstat combinations with PD-1 or PD-L1 inhibitors for cancer, including SCLC.
Key point: The company said protection is expected to run to at least 2040 after formal grant, adding Mexico to Australia, Europe, Japan and Russia.
Implication: Signals pipeline investment and modality expansion.

💶 VALANX raises capital for LIV-1 ADC in mTNBC [4] [EU • 12 Mar 2026]

https://www.news-medical.net/news/20260312/VALANX-Biotech-secures-e282ac3-million-to-advance-LIV-1-ADC-for-metastatic-triple-negative-breast-cancer.aspx
Context: VALANX Biotech secured €3 million to advance VLX-ADC-001, a LIV-1-targeting ADC for metastatic triple-negative breast cancer, and to support GoldenSite GMP readiness.
Key point: Candidate selection is planned for Jun 2026, with Foundation Fournier-Majoie and FUJIFILM joining the financing round.
Implication: Signals pipeline investment and modality expansion.

🎯 Intensity posts early presurgical TNBC Phase 2 signal [5] [12 Mar 2026]

https://ir.intensitytherapeutics.com/news-events/press-releases/detail/121/intensity-therapeutics-inc-provides-update-on-the-phase-2
Context: INVINCIBLE-4 is a Phase 2 randomized presurgical TNBC study of INT230-6 before standard immunochemotherapy versus standard of care alone.
Key point: Intensity reported preliminary pCR observations of 5/7 in Cohort A versus 2/6 evaluable in Cohort B, with 44% fewer grade 3 or higher adverse events in Cohort A.
Implication: May influence prescriber choice and payer reviews pending full data.

🎗️ ENHERTU gets FDA Priority Review in early HER2-positive breast cancer [6] [US • 09 Mar 2026]

https://www.daiichisankyo.com/files/news/pressrelease/pdf/202603/20260309_E.pdf
Context: Daiichi Sankyo and AstraZeneca said the FDA accepted and granted Priority Review to an sBLA for ENHERTU in residual invasive disease after neoadjuvant HER2-targeted therapy.
Key point: DESTINY-Breast05 showed ENHERTU reduced the risk of invasive disease recurrence or death by 53% versus T-DM1, with a PDUFA date of 07 Jul 2026.
Implication: May influence prescriber choice and payer reviews pending full data.

☢️ Telix advances TLX591-Tx in Phase 3 mCRPC program [7] [10 Mar 2026]

https://www.prnewswire.com/apac/news-releases/prostact-global-phase-3-study-part-1-achieves-primary-objectives-302708664.html
Context: ProstACT Global Part 1 enrolled 36 PSMA-positive mCRPC patients previously treated with one ARPI, testing TLX591-Tx with enzalutamide, abiraterone, or docetaxel.
Key point: Telix said Part 1 met primary objectives, showing acceptable safety, no new safety signals, and supportive dosimetry; Part 2 is already underway where approved.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 ImmunityBio resubmits papillary NMIBC filing for ANKTIVA plus BCG [8] [US • 09 Mar 2026]

https://immunitybio.com/immunitybio-announces-resubmission-of-supplemental-bla-to-the-fda-for-anktiva-plus-bcg-in-bcg-unresponsive-nmibc-with-papillary-disease-following-agency-review-of-additional-data/
Context: ImmunityBio resubmitted its sBLA for ANKTIVA plus BCG in BCG-unresponsive NMIBC with papillary tumors after FDA review of additional data.
Key point: The company said the filing now includes updated long-term follow-up from QUILT 3.032 Cohort B, and that FDA has acknowledged receipt.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Kainova reports positive Phase I topline for DT-9081 [9] [10 Mar 2026]

https://www.kainovatx.com/en/press-releases/kainova-therapeutics-announces-positive-phase-i-results-for-dt-9081-an-oral-ep4-receptor-antagonist-in-advanced-solid-tumors/
Context: DT-9081 (Kainova Therapeutics; oral EP4 receptor antagonist) was studied in the EPRAD Phase I trial in advanced, recurrent, and metastatic solid tumors.
Key point: Kainova said the study met all primary objectives, with no dose-limiting toxicities, sustained target engagement, and early anti-tumor activity.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 IDEAYA doses first patient with IDE892 in MTAP-deleted tumors [10] [US • 09 Mar 2026]

https://media.ideayabio.com/2026-03-09-IDEAYA-Biosciences-Announces-First-Patient-In-for-Phase-1-Trial-of-IDE892,-a-Potential-Best-In-Class-PRMT5-Inhibitor-for-MTAP-Deleted-Solid-Tumors,-and-Provides-MTAP-and-CDKN2A-Pipeline-Update
Context: IDE892 (IDEAYA Biosciences; MTA-cooperative PRMT5 inhibitor) entered Phase 1 in MTAP-deleted solid tumors, including NSCLC and PDAC.
Key point: IDEAYA announced first-patient-in for monotherapy, plans a combination first-patient-in with IDE397 in mid-2026, and said it is prioritizing its proprietary MTAP and CDKN2A pipeline.
Implication: Signals pipeline investment and modality expansion.

Why it matters

• ENHERTU (Daiichi Sankyo, AstraZeneca) [6]: Priority Review moves trastuzumab deruxtecan closer to the post-neoadjuvant HER2-positive early breast cancer setting, with a 07 Jul 2026 FDA action date.
• HLX43 (Henlius) [2] and IDE892 (IDEAYA) [10]: NSCLC and MTAP-deleted tumor development remain active areas for ADC and synthetic-lethality strategies.
• TLX591-Tx (Telix) [7] and INT230-6 (Intensity) [5]: Radiopharmaceutical and intratumoral approaches continue to add clinical signal in mCRPC and presurgical TNBC.
• VALANX [4] and Oryzon [3]: Financing and patent updates remain important pipeline support signals, especially for ADC platform development and combo-IP positioning.
• AMXT 1501 (Aminex) [1] and ANKTIVA (ImmunityBio) [8]: Regulatory milestones in rare and high-need settings continue to shape near-term program visibility.

🎯 Catch up on the Top Oncology news from the past two weeks, curated by the LucidQuest team.

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