This week’s Oncology update covers regulatory actions, clinical trial progress, and select IP and filing updates. Items include approvals, expedited development designations, and late-stage program milestones across multiple tumor types.
In Today’s Newsletter
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🧬 Krystal Biotech wins RMAT for KB707 in NSCLC [1] [US • 09 Feb 2026]
Context: KYANITE-1 (ongoing) includes inhaled KB707 in heavily pre-treated advanced NSCLC (NCT06228326).
Key point: FDA granted RMAT designation to KB707 (redosable immunotherapy driving localized IL-2 and IL-12 expression) for advanced or metastatic NSCLC.
Implication: May influence prescriber choice and payer reviews pending full data.
🧾 Genprex gets IP Australia notice of acceptance for Reqorsa combo claims [2] [10 Feb 2026]
Context: Source cites Acclaim-3 (Phase 1/2) evaluating Reqorsa plus Tecentriq (atezolizumab) as maintenance in ES-SCLC, and notes an additional trial site opened.
Key point: IP Australia issued a Notice of Acceptance (intent to grant) for claims covering Reqorsa (quaratusugene ozeplasmid) in combination with PD-L1 antibodies.
Implication: Signals pipeline investment and modality expansion.
🇯🇵 Daiichi Sankyo files Japan sNDA for DATROWAY in metastatic TNBC (1L, immunotherapy-ineligible) [3] [Japan • 12 Feb 2026]
https://www.daiichisankyo.com/files/news/pressrelease/pdf/202602/20260212_E.pdf
Context: Filing cites Phase 3 TROPION-Breast02 (global, randomized, open-label) versus investigator’s choice chemotherapy in previously untreated locally recurrent inoperable or metastatic TNBC where immunotherapy was not an option.
Key point: Daiichi Sankyo submitted an sNDA to Japan MHLW for DATROWAY (datopotamab deruxtecan) in HR-negative, HER2-negative unresectable or recurrent breast cancer (TNBC).
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 Innovent starts pivotal Phase 3 for IBI354 HER2 ADC in 1L HER2+ metastatic breast cancer [4] [China • 12 Feb 2026]
Context: HeriCare-Breast01 (NCT07377643) compares IBI354 (± pertuzumab) vs paclitaxel + trastuzumab + pertuzumab, primary endpoint PFS.
Key point: Innovent reported first participant dosed in pivotal Phase 3 HeriCare-Breast01 for IBI354 as first-line therapy in unresectable locally advanced or metastatic HER2+ breast cancer.
Implication: May influence prescriber choice and payer reviews pending full data.
🧫 SOFIE doses first patient in Phase 3 [18F]FAPI-74 PET/CT study in pancreatic cancer [5] [US • 11 Feb 2026]
Context: FAPI-PRO is multi-site, open-label, non-randomized, single-dose imaging study in PDAC (planned 18 sites; estimated enrollment stated as 200).
Key point: SOFIE announced first patient dosed in Phase 3 FAPI-PRO evaluating [18F]FAPI-74 PET/CT to detect distant metastatic disease in pancreatic ductal adenocarcinoma.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🏷️ HanchorBio wins FDA Orphan Drug Designation for HCB101 in gastric cancer [6] [US • 13 Feb 2026]
Context: HCB101 is a CD47–SIRPα pathway inhibitor (SIRPα–IgG4 Fc fusion protein), with an ongoing Phase 1b/2a combo study referenced (NCT06771622).
Key point: HanchorBio said FDA granted Orphan Drug Designation to HCB101 for gastric cancer (including HER2-positive and HER2-negative subtypes).
Implication: Signals pipeline investment and modality expansion.
🧬 Henlius doses first patient in Phase 1b/2 HLX43 (PD-L1 ADC) combo trial in mCRC [7] [China • 11 Feb 2026]
https://www.henlius.com/en/NewsDetails-5749-26.html
Context: HLX43-mCRC202 evaluates HLX43 with serplulimab (anti-PD-1) or HLX07 (anti-EGFR), with Q3W dosing and dose levels described in the source.
Key point: Henlius reported first patient dosed in China in a Phase 1b/2 study of HLX43 in combination regimens for advanced or metastatic colorectal cancer.
Implication: May influence prescriber choice and payer reviews pending full data.
✅ FDA approves KEYTRUDA and KEYTRUDA QLEX regimen in PD-L1+ platinum-resistant ovarian carcinoma [8] [US • 11 Feb 2026]
Context: Approval based on Phase 3 KEYNOTE-B96 (ENGOT-ov65) in platinum-resistant recurrent ovarian cancer; PD-L1+ defined as CPS ≥1 by an FDA-authorized test.
Key point: FDA approved pembrolizumab (IV) and pembrolizumab plus berahyaluronidase alfa (subcutaneous, KEYTRUDA QLEX) with paclitaxel (± bevacizumab) for certain adults after 1–2 prior systemic regimens.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Adlai Nortye doses first US patient in Phase 1 for pan-RAS(ON) inhibitor AN9025 [9] [US • 12 Feb 2026]
Context: First-in-human, multicenter, open-label Phase 1 in advanced or metastatic solid tumors with RAS mutations; MRCT noted with Jiangsu Aosaikang, with split regional rights.
Key point: Adlai Nortye reported first US patient dosed (early Feb 2026) in Phase 1 trial of AN9025, an oral pan-RAS(ON) inhibitor.
Implication: Signals pipeline investment and modality expansion.
🧴 Biofrontera FDA accepts sNDA filing for Ameluz PDT in superficial BCC, PDUFA set [10] [US • 11 Feb 2026]
https://investors.biofrontera-us.com/full-news/?qm-storyId=5387383170976717
Context: sNDA seeks label expansion for Ameluz (aminolevulinic acid HCl topical gel) used with RhodoLED red-light lamps.
Key point: FDA accepted Biofrontera’s sNDA for Ameluz PDT in superficial basal cell carcinoma, and set a PDUFA target action date of 28 Sep 2026.
Implication: May influence prescriber choice and payer reviews pending full data.
Why it matters
- RMAT and orphan designations can de-risk timelines and strengthen partnering narratives for oncology programs. [1], [6]
- FDA approval of pembrolizumab regimens in platinum-resistant ovarian cancer expands IO use in a biomarker-defined population. [8]
- Japan’s DATROWAY filing adds pressure to the evolving ADC landscape in metastatic TNBC, especially for immunotherapy-ineligible patients. [3]
- Multiple first-patient-dosed updates highlight continued clinical throughput across ADCs, RAS targeting, and radiopharmaceutical imaging. [4], [5], [7], [9]
- FDA filing acceptance for Ameluz sets a clear regulatory milestone with a stated action date. [10]
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FAQ
What does RMAT mean for KB707 (Krystal Biotech)?
RMAT is an FDA designation to expedite development of regenerative medicine therapies when preliminary clinical evidence suggests potential benefit in a serious disease. It can enable intensive FDA interaction and options like rolling review. [1]
What is IP Australia’s “Notice of Acceptance” for Genprex’s Reqorsa claims?
It indicates IP Australia’s intent to grant the patent application (subject to final steps), covering Reqorsa used in combination with PD-L1 antibodies, per the company. [2]
What is Daiichi Sankyo asking Japan to approve for DATROWAY?
An sNDA to Japan’s MHLW for DATROWAY (datopotamab deruxtecan) in HR-negative, HER2-negative unresectable or recurrent breast cancer (TNBC), positioned as first line in metastatic TNBC patients not eligible for immunotherapy (as described). [3]
What is Innovent’s HeriCare-Breast01 study testing?
A Phase 3 comparison of IBI354 (with or without pertuzumab) versus paclitaxel plus trastuzumab and pertuzumab, with PFS as the primary endpoint, in 1L HER2+ advanced or metastatic breast cancer. [4]
Is [18F]FAPI-74 a treatment?
In the SOFIE announcement, it is a diagnostic PET tracer being evaluated for clinical utility (PET/CT) in detecting metastatic disease in PDAC. [5]
What does FDA filing acceptance mean for Biofrontera’s Ameluz sNDA?
It means FDA will review the submitted application for the proposed new indication, and FDA provided a PDUFA target action date (28 Sep 2026) for its decision. [10]
Entities / Keywords
Krystal Biotech (KRYS), KB707, RMAT, KYANITE-1, NSCLC
Genprex (GNPX), Reqorsa (quaratusugene ozeplasmid), IP Australia, Acclaim-3, Tecentriq (atezolizumab)
Daiichi Sankyo, DATROWAY (datopotamab deruxtecan), TROP2 ADC, TROPION-Breast02, Japan MHLW, TNBC
Innovent Biologics, IBI354, HeriCare-Breast01, HER2 ADC, pertuzumab, trastuzumab, paclitaxel
SOFIE Biosciences, [18F]FAPI-74, FAPI-PRO, PET/CT, PDAC
HanchorBio, HCB101, CD47–SIRPα, Orphan Drug Designation, gastric cancer
Henlius, HLX43 (PD-L1 ADC), serplulimab, HLX07, mCRC
Merck (MSD), KEYTRUDA (pembrolizumab), KEYTRUDA QLEX, KEYNOTE-B96 (ENGOT-ov65), platinum-resistant ovarian cancer, PD-L1 CPS ≥1
Adlai Nortye (ANL), AN9025, pan-RAS(ON) inhibitor, Phase 1, RAS mutations
Biofrontera (BFRI), Ameluz, photodynamic therapy, RhodoLED, superficial basal cell carcinoma, PDUFA