Oncology Today—April 20, 2026

This week’s Oncology update highlights regulatory progress, pivotal clinical data, financing support, and partnership activity across multiple solid tumor programs.

In Today’s Newsletter

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🫁 Ifinatamab deruxtecan gets FDA Priority Review [1] [US • 13 Apr 2026]

https://www.daiichisankyo.com/files/news/pressrelease/pdf/202604/20260413_E.pdf
Context: Daiichi Sankyo and Merck & Co. filed for previously treated extensive-stage small cell lung cancer, supported by Phase 2 IDeate-Lung01 and Phase 1/2 IDeate-PanTumor01.
Key point: FDA accepted the BLA and granted Priority Review for ifinatamab deruxtecan, a B7-H3-directed DXd ADC, with a PDUFA date of 10 Oct 2026.
Implication: May influence prescriber choice and payer reviews pending full data.

🎯 Boehringer Ingelheim and Zai Lab pair two DLL3 agents in SCLC [2] [EU/China • 15 Apr 2026]

https://www.boehringer-ingelheim.com/science-innovation/human-health-innovation/boehringer-ingelheim-and-zai-lab-announce-collaboration-dll3-targeting-t-cell-engager-and-adc
Context: Phase Ib/II will evaluate obrixtamig, a DLL3/CD3 T-cell engager, with zocilurtatug pelitecan, a DLL3-targeting ADC, in ES-SCLC and poorly differentiated NECs.
Key point: The collaboration opens a dual DLL3-targeting combination study focused on safety, tolerability, and initial clinical activity.
Implication: Signals pipeline investment and modality expansion.

🧬 Astellas starts Phase 3 setidegrasib in KRAS G12D PDAC [3] [15 Apr 2026]

https://newsroom.astellas.com/2026-04-15-astellas-doses-first-patient-in-phase-3-study-of-setidegrasib-for-kras-g12d-mutated-metastatic-pancreatic-ductal-adenocarcinoma
Context: The randomized, double-blind, placebo-controlled study plans to enroll more than 600 patients with KRAS G12D-mutated metastatic PDAC; primary endpoint is overall survival.
Key point: Astellas dosed the first patient in Phase 3 for setidegrasib, a KRAS G12D-targeted protein degrader, combined with mFOLFIRINOX or NALIRIFOX in first line.
Implication: May influence prescriber choice and payer reviews pending full data.

🩺 Sirtex reports strong DOORwaY90 HCC data for SIR-Spheres [4] [US • 13 Apr 2026]

https://sirtex.com/us/news/press-releases/news-item?id=5517
Context: DOORwaY90 is described as a prospective, multicenter U.S. trial of Y-90 SIRT using partition dosimetry in unresectable hepatocellular carcinoma.
Key point: Sirtex reported 12-month DOORwaY90 results including 90% complete response, 99% best overall response rate, and 100% local tumor control.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 PDS01ADC interim Phase 2 data published in mCRC liver metastases [5] [15 Apr 2026]

https://www.pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/134-2026-news/1035-pds-biotech-announces-publication-of-positive-pds01adc-inter2026-04-15-055033
Context: NCI-led, open-label, single-center, non-randomized Phase 2 trial in MSS or pMMR metastatic colorectal cancer with liver metastases; Stage 1 reported for the mCRC cohort.
Key point: PDS Biotech highlighted interim data for PDS01ADC plus HAIP/FUDR, including higher response and survival versus a parallel trial without PDS01ADC.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧫 Vir expands VIR-5500 into metastatic prostate cancer cohorts [6] [US • 13 Apr 2026]

https://investors.vir.bio/news/news-details/2026/Vir-Biotechnology-Announces-First-Patient-Dosed-in-Phase-1-Dose-expansion-Cohorts-Evaluating-PSMA-targeted-PRO-XTEN-Dual-masked-T-cell-Engager-VIR-5500-in-Patients-with-Metastatic-Prostate-Cancer/default.aspx
Context: Phase 1 expansion follows earlier monotherapy dose-escalation data in mCRPC; cohorts span late-line mCRPC monotherapy and combinations in earlier-line disease.
Key point: Vir Biotechnology announced first patient dosed in dose-expansion for VIR-5500, a PSMA-targeted, dual-masked T-cell engager in metastatic prostate cancer.
Implication: Signals pipeline investment and modality expansion.

🧾 Kura posts cabozantinib-pretreated ccRCC subset data for darlifarnib [7] [EU • 17 Apr 2026]

https://ir.kuraoncology.com/news-releases/news-release-details/kura-oncology-reports-darlifarnib-plus-cabozantinib-demonstrates
Context: Subset analysis came from the ongoing FIT-001 trial in clear cell renal cell carcinoma previously treated with cabozantinib.
Key point: Kura reported 44% ORR and 94% DCR in 16 cabozantinib-pretreated ccRCC patients receiving darlifarnib plus cabozantinib.
Implication: May influence prescriber choice and payer reviews pending full data.

🏭 Forlong moves FL115 toward pivotal-readiness in NMIBC [8] [China • 16 Apr 2026]

http://www.forlongbiotech.com/en/news/31.html
Context: Forlong said CMC transfer and analytical methods are complete, with GMP batch production planned to support an upcoming pivotal trial for FL115 in NMIBC.
Key point: The company announced manufacturing readiness for FL115, an IL-15 superagonist, while citing ongoing clinical experience in BCG-unresponsive NMIBC.
Implication: Signals pipeline investment and modality expansion.

🧬 Partner Therapeutics files BIZENGRI sBLA in NRG1 fusion cholangiocarcinoma [9] [US • 14 Apr 2026]

https://www.partnertx.com/partner-therapeutics-announces-submission-of-supplemental-biologics-license-application-sbla-to-fda-for-bizengri-zenocutuzumab-zbco-in-nrg1-fusion-positive-cholangiocarcinoma-and-inclusion-i/
Context: Filing is supported by data from the eNRGy study, and Partner Therapeutics also said NCCN updated its biliary tract cancer guidance to include zenocutuzumab-zbco.
Key point: The sBLA seeks approval for BIZENGRI (zenocutuzumab-zbco) in adults with advanced unresectable or metastatic NRG1 fusion-positive cholangiocarcinoma.
Implication: Introduces competition that may affect pricing and formulary access.

💉 Samsung Bioepis starts Phase 1 for SBE303, a Nectin-4 ADC [10] [Korea • 14 Apr 2026]

https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=546&currentPage=1
Context: First-in-human, open-label, multi-center Phase 1 will assess safety, tolerability, and efficacy in advanced refractory solid tumors.
Key point: Samsung Bioepis initiated clinical testing of SBE303, its first novel ADC candidate, targeting Nectin-4.
Implication: Signals pipeline investment and modality expansion.

Why it matters

Small cell lung cancer was a standout theme this week, with a near-term regulatory milestone for ifinatamab deruxtecan [1] and a new DLL3 combination strategy from Boehringer Ingelheim and Zai Lab [2].
Precision oncology kept moving deeper into biomarker-defined settings, including KRAS G12D pancreatic cancer [3], NRG1 fusion cholangiocarcinoma [9], and PSMA-targeted prostate cancer [6].
ADC momentum broadened across mechanisms and companies, including B7-H3, DLL3, and Nectin-4 programs from Daiichi Sankyo, Zai Lab, and Samsung Bioepis [1][2][10].
Several items were still early or non-randomized, so interpretation should stay tied to study design, subset size, and source-reported endpoints [5][6][7][10].
Operational progress also mattered, with Forlong emphasizing CMC readiness before a planned pivotal-stage NMIBC program [8].

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FAQ

What is ifinatamab deruxtecan, and why does Priority Review matter?

Ifinatamab deruxtecan is a B7-H3-directed DXd antibody-drug conjugate from Daiichi Sankyo and Merck & Co. for previously treated ES-SCLC. Priority Review sets an FDA action date of 10 Oct 2026, which can speed the regulatory timeline [1].

What is distinctive about the Boehringer Ingelheim and Zai Lab DLL3 collaboration?

It combines two DLL3-directed approaches, obrixtamig, a T-cell engager, and zocilurtatug pelitecan, an ADC, in one Phase Ib/II study. The goal is to assess safety and early activity in SCLC and other NECs [2].

Why is Astellas’ setidegrasib Phase 3 start notable?

Setidegrasib targets KRAS G12D through targeted protein degradation, and Astellas states it is the first KRAS-mutation-targeted degrader to enter Phase 3. The study is in first-line KRAS G12D-mutated metastatic PDAC [3].

How should readers interpret the PDS01ADC colorectal data?

The signal looks encouraging, but the company described a non-randomized interim analysis with comparison to a parallel trial rather than a head-to-head study. That makes study design and confounding especially important when reading the results [5].

What changed for BIZENGRI in cholangiocarcinoma?

Partner Therapeutics submitted an FDA supplemental BLA for NRG1 fusion-positive cholangiocarcinoma and said NCCN added zenocutuzumab-zbco to updated biliary tract cancer guidance. This builds on existing accelerated approvals in NRG1 fusion-positive NSCLC and pancreatic cancer [9].

What is SBE303, and where does it fit in Samsung Bioepis’ pipeline?

SBE303 is Samsung Bioepis’ first novel ADC candidate and targets Nectin-4 in advanced refractory solid tumors. The company announced Phase 1 initiation, so the program is at a first-in-human stage [10].

Entities / Keywords

Ifinatamab deruxtecan, I-DXd, Daiichi Sankyo, Merck & Co., MSD, B7-H3 ADC, ES-SCLC
Obrixtamig, zocilurtatug pelitecan, zoci, ZL-1310, Boehringer Ingelheim, Zai Lab, DLL3, SCLC, NEC
Setidegrasib, ASP3082, Astellas, KRAS G12D, protein degrader, PDAC
SIR-Spheres, Sirtex Medical, DOORwaY90, Y-90, SIRT, HCC
PDS01ADC, PDS Biotech, IL-12 immunocytokine, HAIP, FUDR, MSS, pMMR, mCRC
VIR-5500, Vir Biotechnology, PRO-XTEN, PSMA, T-cell engager, mCRPC, mHSPC
Darlifarnib, KO-2806, Kura Oncology, cabozantinib, FIT-001, ccRCC
FL115, Forlong Biotechnology, IL-15 superagonist, NMIBC, BCG-unresponsive
BIZENGRI, zenocutuzumab-zbco, Partner Therapeutics, NRG1 fusion, cholangiocarcinoma
SBE303, Samsung Bioepis, Nectin-4 ADC, refractory solid tumors