This week’s Oncology update highlights regulatory momentum, late-stage clinical progress, and filing activity across lung, bladder, gastrointestinal, pancreatic, breast, and brain cancers.
In Today’s Newsletter
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🧠 Siren Biotechnology clears first-in-human path for SRN-101 [1] [US • 23 Mar 2026]
https://sirenbiotechnology.com/siren-biotechnology-announces-fda-clearance-of-investigator-initiated-ind-to-advance-phase-1-study-in-recurrent-high-grade-glioma/
Context: Siren Biotechnology, UCSF, and CIRM disclosed FDA clearance of an investigator-initiated IND for SRN-101 in recurrent high-grade glioma.
Key point: FDA clearance enables a single-center Phase 1 study in adults with recurrent high-grade glioma, led by UCSF.
Implication: May influence prescriber choice and payer reviews pending full data.
🎯 GSK adds Japan orphan status for risvutatug rezetecan in SCLC [2] [Japan • 23 Mar 2026]
https://www.gsk.com/en-gb/media/press-releases/gsk-s-b7-h3-targeted-antibody-drug-conjugate-risvutatug-rezetecan-granted-orphan-drug-designation-for-small-cell-lung-cancer-in-japan/
Context: Risvutatug rezetecan (GSK, B7-H3-targeted ADC) received Orphan Drug Designation from Japan’s Ministry of Health, Labour and Welfare.
Key point: The designation was supported by early ARTEMIS-001 data showing durable responses in certain extensive-stage SCLC patients.
Implication: Signals pipeline investment and modality expansion.
🫁 PharmaMar wins positive CHMP opinion for Zepzelca combo in ES-SCLC [3] [EU • 27 Mar 2026]
https://pharmamar.com/en/pharmamar-receives-recommendation-for-the-approval-from-the-european-medicines-agency-for-zepzelca-lurbinectedin-for-the-treatment-of-extensive-stage-small-cell-lung-cancer-in-combination-with/
Context: Zepzelca (lurbinectedin, PharmaMar) plus atezolizumab was reviewed as first-line maintenance in extensive-stage small cell lung cancer.
Key point: CHMP recommended approval based on Phase 3 IMforte data, with improved PFS and OS versus atezolizumab monotherapy.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Taletrectinib reaches EMA review in ROS1-positive NSCLC [4] [EU • 26 Mar 2026]
https://investors.nuvationbio.com/news/news-details/2026/Eisai-and-Nuvation-Bio-Announce-Marketing-Authorisation-Application-for-Taletrectinib-for-the-Treatment-of-Advanced-ROS1-Positive-Non-Small-Cell-Lung-Cancer-Validated-by-the-European-Medicines-Agency/default.aspx
Context: Eisai and Nuvation Bio said the EMA validated the MAA for taletrectinib in advanced ROS1-positive NSCLC.
Key point: The filing, based on TRUST-I and TRUST-II, was accepted for full approval consideration under a standard review timeline.
Implication: May influence prescriber choice and payer reviews pending full data.
⚙️ TRIANA secures FDA Fast Track for TRI-611 in ALK-positive NSCLC [5] [US • 25 Mar 2026]
https://trianabio.com/press-release-032526-01
Context: TRI-611 (TRIANA Biomedicines) is an oral, brain-penetrant molecular glue degrader targeting ALK fusion proteins.
Key point: FDA granted Fast Track designation for ALK-positive NSCLC in patients previously treated with two or more ALK TKIs.
Implication: Signals pipeline investment and modality expansion.
🎀 Alphamab Oncology doses first patient in Phase 3 adjuvant breast cancer study [6] [China • 24 Mar 2026]
https://www.alphamabonc.com/en/html/news/2774.html
Context: Alphamab Oncology started Phase 3 KN026-007 of anbenitamab (KN026) plus HB1801 and chemotherapy in HER2-positive breast cancer.
Key point: The first patient was dosed in a study expected to enroll approximately 1,800 patients with resectable HER2-positive disease and four or more positive lymph nodes.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 Ono files ripretinib in Japan for advanced GIST [7] [Japan • 26 Mar 2026]
https://prd.ono.co.jp/en/news/20260326.html
Context: Ono submitted ripretinib, developed by Deciphera, for gastrointestinal stromal tumor progressing after prior cancer chemotherapy.
Key point: The application is supported by Phase 3 INVICTUS, where ripretinib improved progression-free survival versus placebo.
Implication: Introduces competition that may affect pricing and formulary access.
🧫 Theriva aligns with FDA on Phase 3 VCN-01 design in metastatic PDAC [8] [US • 23 Mar 2026]
https://therivabio.com/press_releases/theriva-biologics-announces-positive-end-of-phase-2-meeting-with-u-s-fda-regarding-the-design-of-a-phase-3-trial-of-vcn-01-in-metastatic-pancreatic-ductal-adenocarcinoma/
Context: Theriva Biologics reported a positive End-of-Phase 2 meeting on VCN-01 plus gemcitabine/nab-paclitaxel in first-line metastatic PDAC.
Key point: FDA broadly agreed with the proposed pivotal Phase 3 design, including overall survival as primary endpoint and an adaptive design.
Implication: Signals pipeline investment and modality expansion.
🩺 Eisai and MSD file Lenvima plus Welireg regimen update in Japan RCC [9] [Japan • 23 Mar 2026]
https://www.eisai.com/news/2026/pdf/enews202621pdf.pdf
Context: Eisai and MSD submitted an application in Japan to add dosage and administration for Lenvima with Welireg in advanced RCC after prior therapy.
Key point: The filing is based on Phase 3 LITESPARK-011, where the combination improved progression-free survival versus cabozantinib.
Implication: May influence prescriber choice and payer reviews pending full data.
🚰 Astellas expands PADCEV plus Keytruda review in MIBC [10] [EU • 23 Mar 2026]
https://newsroom.astellas.com/2026-03-23-ema-validates-type-II-variation-application-for-padcev-enfortumab-vedotin-plus-keytruda-pembrolizumab-in-cisplatin-eligible-patients-with-muscle-invasive-bladder-cancer
Context: Astellas said EMA validated a Type II variation for PADCEV (enfortumab vedotin) plus Keytruda in cisplatin-eligible muscle-invasive bladder cancer.
Key point: The application is supported by Phase 3 EV-304 / KEYNOTE-B15, which showed better event-free outcomes and overall survival versus gemcitabine plus cisplatin.
Implication: May influence prescriber choice and payer reviews pending full data.
Why it matters
- Lung cancer dominated the week, spanning SCLC, ROS1-positive NSCLC, and ALK-positive NSCLC across regulatory, filing, and early-development milestones [2][3][4][5].
- Europe saw multiple late-stage oncology review advances, including lurbinectedin in ES-SCLC, taletrectinib in ROS1-positive NSCLC, and enfortumab vedotin plus pembrolizumab in MIBC [3][4][10].
- Japan was notably active on oncology filings, with risvutatug rezetecan orphan status, ripretinib filing in GIST, and a Lenvima plus Welireg regimen update in RCC [2][7][9].
- Several items point to continued momentum for targeted agents and ADCs, including B7-H3, HER2, Nectin-4, ROS1, and ALK programs [2][4][5][6][10].
- Early and mid-stage programs also advanced, including SRN-101 in recurrent high-grade glioma and VCN-01 in metastatic PDAC [1][8].
🎯 Catch up on the Top Oncology news from the past two weeks, curated by the LucidQuest team.
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FAQ
What happened with SRN-101 at Siren Biotechnology?
Siren Biotechnology said FDA cleared an investigator-initiated IND from UCSF, enabling a Phase 1 study of SRN-101 in adults with recurrent high-grade glioma [1]. The company described the study as single-center and focused on safety and biologic activity [1].
Why does GSK’s risvutatug rezetecan update matter in SCLC?
Japan granted Orphan Drug Designation to risvutatug rezetecan for small-cell lung cancer, adding another regulatory designation for the B7-H3 ADC [2]. GSK said the decision was supported by preliminary ARTEMIS-001 data showing durable responses in certain ES-SCLC patients [2].
What is the latest regulatory step for taletrectinib in Europe?
Eisai and Nuvation Bio said the EMA validated the MAA for taletrectinib in advanced ROS1-positive NSCLC [4]. Validation means the application has entered formal review, with a standard timeline and full approval consideration [4].
What is TRI-611, and what did the FDA grant?
TRI-611 is TRIANA Biomedicines’ oral molecular glue degrader targeting ALK fusion proteins in ALK-positive NSCLC [5]. FDA granted Fast Track designation for patients previously treated with two or more ALK TKIs [5].
What did the EV-304 / KEYNOTE-B15 data support for PADCEV plus Keytruda?
Astellas said the EMA validated a Type II variation for use in cisplatin-eligible MIBC, supported by Phase 3 EV-304 / KEYNOTE-B15 [10]. The company reported reductions in recurrence, progression, or death, plus an overall survival benefit versus standard neoadjuvant gemcitabine and cisplatin [10].
What is new for VCN-01 in metastatic pancreatic cancer?
Theriva Biologics said FDA generally agreed with the proposed Phase 3 design for VCN-01 plus gemcitabine/nab-paclitaxel in first-line metastatic PDAC [8]. The agency aligned on key elements including overall survival as the primary endpoint and an adaptive design [8].
Entities / Keywords
Siren Biotechnology, SRN-101, recurrent high-grade glioma, UCSF, investigator-initiated IND
GSK, risvutatug rezetecan, Ris-Rez, B7-H3 ADC, small-cell lung cancer, ES-SCLC
PharmaMar, Zepzelca, lurbinectedin, atezolizumab, IMforte, ES-SCLC
Eisai, Nuvation Bio, taletrectinib, IBTROZI, ROS1-positive NSCLC, TRUST-I, TRUST-II
TRIANA Biomedicines, TRI-611, ALK-positive NSCLC, molecular glue degrader
Alphamab Oncology, anbenitamab, KN026, HB1801, HER2-positive breast cancer, KN026-007
Ono Pharmaceutical, Deciphera, ripretinib, QINLOCK, GIST, INVICTUS
Theriva Biologics, VCN-01, metastatic PDAC, VIRAGE
Lenvima, lenvatinib, Welireg, belzutifan, RCC, LITESPARK-011
Astellas, PADCEV, enfortumab vedotin, Keytruda, pembrolizumab, MIBC, EV-304, KEYNOTE-B15
References
- https://sirenbiotechnology.com/siren-biotechnology-announces-fda-clearance-of-investigator-initiated-ind-to-advance-phase-1-study-in-recurrent-high-grade-glioma/
- https://www.gsk.com/en-gb/media/press-releases/gsk-s-b7-h3-targeted-antibody-drug-conjugate-risvutatug-rezetecan-granted-orphan-drug-designation-for-small-cell-lung-cancer-in-japan/
- https://pharmamar.com/en/pharmamar-receives-recommendation-for-the-approval-from-the-european-medicines-agency-for-zepzelca-lurbinectedin-for-the-treatment-of-extensive-stage-small-cell-lung-cancer-in-combination-with/
- https://investors.nuvationbio.com/news/news-details/2026/Eisai-and-Nuvation-Bio-Announce-Marketing-Authorisation-Application-for-Taletrectinib-for-the-Treatment-of-Advanced-ROS1-Positive-Non-Small-Cell-Lung-Cancer-Validated-by-the-European-Medicines-Agency/default.aspx
- https://trianabio.com/press-release-032526-01
- https://www.alphamabonc.com/en/html/news/2774.html
- https://prd.ono.co.jp/en/news/20260326.html
- https://therivabio.com/press_releases/theriva-biologics-announces-positive-end-of-phase-2-meeting-with-u-s-fda-regarding-the-design-of-a-phase-3-trial-of-vcn-01-in-metastatic-pancreatic-ductal-adenocarcinoma/
- https://www.eisai.com/news/2026/pdf/enews202621pdf.pdf
- https://newsroom.astellas.com/2026-03-23-ema-validates-type-II-variation-application-for-padcev-enfortumab-vedotin-plus-keytruda-pembrolizumab-in-cisplatin-eligible-patients-with-muscle-invasive-bladder-cancer