Oncology Today—February 2, 2026

LucidQuest

3 hours ago

This weekly update in oncology covers regulatory actions, clinical progress, and data releases across solid tumors. Highlights include filings, positive regulatory opinions, expedited designations, and early-phase readouts that may influence future standards of care.

In Today’s Newsletter

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🧫 CytoDyn funds TNBC expanded access for leronlimab [1] [US • 27 Jan 2026]

https://www.cytodyn.com/newsroom/press-releases/detail/654/cytodyn-announces-funding-and-initiation-of-expanded-access
Context: EAP aims to provide access to patients ineligible for trials and observe PD-L1 induction to inform potential ICI combinations.
Key point: A benefactor will fund an Expanded Access Program for leronlimab in advanced TNBC, with WEP Clinical as CRO and opening targeted for March 2026 pending FDA allowance.
Implication: May expand screening, initiation, and follow-up at scale.

🧠 Kazia’s paxalisib combo shows early TNBC responses [2] [AU • 27 Jan 2026]

https://www.kaziatherapeutics.com/site/pdf/9632aa12-66ab-4b4b-814d-bf37679d72b6/Kazia-Therapeutics-Reports-Encouraging-Preliminary-Clinical-Responses-in-Ongoing-Phase-1b-Study-of-Paxalisib-in-LateStage-Metastatic-TripleNegative-Breast-Cancer.pdf
Context: Open-label TNBC cohorts, PD-L1-positive selection for pembro-chemo arm, paxalisib 30 mg daily; safety generally favorable to date.
Key point: Phase 1b update reports two partial responses in-trial and a confirmed complete metabolic response under expanded access with pembrolizumab + chemo + paxalisib.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 Bezuclastinib + sunitinib wins FDA BTD in GIST [3] [US • 26 Jan 2026]

https://investors.cogentbio.com/news-releases/news-release-details/cogent-biosciences-announces-breakthrough-therapy-designation
Context: Company will submit an RTOR NDA with completion targeted for April 2026; full results planned in H1 2026.
Key point: FDA granted Breakthrough Therapy Designation for bezuclastinib + sunitinib in GIST after imatinib, based on PEAK’s significant PFS benefit vs sunitinib.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Tecentriq adjuvant filing for ctDNA-positive MIBC in Japan [4] [JP • 28 Jan 2026]

https://www.chugai-pharm.co.jp/english/news/detail/20260128153001_1223.html
Key point: Chugai filed to add Tecentriq as adjuvant therapy in ctDNA MRD-positive MIBC after surgery, with significant DFS and OS in IMvigor011.
Context: Safety consistent with prior Tecentriq studies; filing targets personalized, MRD-guided care.
Implication: May influence prescriber choice and payer reviews pending full data.

💉 PADCEV + Keytruda Japan sNDA in cisplatin-ineligible MIBC [5] [JP • 30 Jan 2026]

https://newsroom.astellas.com/2026-01-30-astellas-submits-supplemental-new-drug-application-in-japan-for-padcev-tm-enfortumab-vedotin-with-keytruda-r-pembrolizumab-for-certain-patients-with-muscle-invasive-bladder-cancer
Context: US approval in Nov 2025; EU Type II variation under review; no new safety signals in EV-303.
Key point: Astellas submitted an sNDA for perioperative enfortumab vedotin + pembrolizumab in MIBC, citing 60% EFS and 50% OS risk reductions vs surgery alone in EV-303.
Implication: May influence prescriber choice and payer reviews pending full data.

🌱 Jyong Biotech Phase 2 biomarker update for MCS-8 [6] [TW • 30 Jan 2026]

https://finance.yahoo.com/news/jyong-biotech-subsidiary-announces-phase-133000440.html
Context: Botanical candidate in Taiwan targeting prostate cancer prevention; exploratory metabolic findings and tolerability described.
Key point: Two-year data show total cholesterol reduction (P=0.036) and LDH increase in placebo only (P=0.024); prior disclosure noted reduced prostate cancer incidence.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

💊 AKEEGA CHMP positive opinion in BRCA-mutant mHSPC [7] [EU • 30 Jan 2026]

https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-chmp-positive-opinion-for-akeega-niraparib-and-abiraterone-acetate-dual-action-tablet-for-the-treatment-of-patients-with-metastatic-hormone-sensitive-prostate-cancer-mhspc-with-brca1-2-mutations
Context: Early OS trend favoring combo; safety consistent with mCRPC experience where authorized.
Key point: CHMP recommended niraparib + abiraterone acetate DAT with ADT for mHSPC with BRCA1/2 mutations, based on AMPLITUDE rPFS and time to symptomatic progression.
Implication: Introduces competition that may affect pricing and formulary access.

🛡️ Zynyz + chemo CHMP positive opinion in first-line SCAC [8] [EU • 30 Jan 2026]

https://investor.incyte.com/news-releases/news-release-details/incyte-announces-positive-chmp-opinion-zynyzr-retifanlimab-first
Context: POD1UM-303/InterAACT2 showed significant PFS improvement vs placebo combo; no new safety signals.
Key point: CHMP backed Zynyz (retifanlimab) with platinum-based chemo for first-line metastatic or inoperable recurrent SCAC.
Implication: Introduces competition that may affect pricing and formulary access.

🧷 Elevar files FDA NDA for FGFR2-positive CCA (second line) [9] [US • 28 Jan 2026]

https://elevartx.com/2026/01/28/elevar-therapeutics-new-drug-application-lirafugratinib/
Context: Independent review ORR 46.5%, median DOR 11.8 months, median PFS 11.3 months in FGFRi-naïve cohort; class-typical toxicities manageable.
Key point: NDA submitted for lirafugratinib in FGFR2 fusion/rearranged CCA after prior therapy, supported by ReFocus efficacy and safety.
Implication: May influence prescriber choice and payer reviews pending full data.

🧑‍⚕️ Scancell IND cleared for global Phase 3 iSCIB1+ in melanoma [10] [US • 26 Jan 2026]

https://www.biospace.com/press-releases/scancell-announces-fda-clearance-of-ind-application-for-global-phase-3-trial-of-iscib1-in-advanced-melanoma
Context: Phase 2 SCOPE suggested improved PFS vs historic controls in selected HLA populations; company exploring financing and partnerships.
Key point: FDA cleared IND for registrational Phase 3 of iSCIB1+ using PFS as surrogate endpoint in advanced melanoma.
Implication: Signals pipeline investment and modality expansion.

Why it Matters

MRD-guided adjuvant therapy in MIBC could align treatment with recurrence risk using ctDNA status.
Perioperative regimens for cisplatin-ineligible MIBC may redefine pathways with IO + ADC combinations.
Precision oncology momentum continues in KIT-mutant GIST and FGFR2-altered CCA with expedited and registrational moves.
EU first-line SCAC immunotherapy would expand options in a rare HPV-linked tumor.
Early-phase TNBC and melanoma signals sustain interest in immunotherapy-plus regimens.

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FAQ

What is leronlimab’s status in TNBC and who runs the EAP?

CytoDyn received donor funding to initiate an FDA-guided EAP for advanced TNBC, with WEP Clinical as CRO, aiming to open in March 2026 pending protocol allowance [1].

How robust are Kazia’s TNBC data with paxalisib?

They are preliminary, from a small open-label Phase 1b and one expanded-access case, showing PRs and a confirmed complete metabolic response with pembrolizumab + chemo + paxalisib at 30 mg daily [2].

Why did bezuclastinib + sunitinib receive BTD?

PEAK demonstrated a statistically significant PFS improvement vs sunitinib in post-imatinib GIST, meeting criteria for potential substantial improvement over available therapy [3].

What differentiates Chugai’s Tecentriq filing from standard adjuvant care?

It targets adjuvant therapy only for ctDNA MRD-positive MIBC, with significant DFS and OS in IMvigor011 and safety consistent with prior use [4].

What did EV-303 show for PADCEV + Keytruda in MIBC?

Risk reductions of 60% for EFS and 50% for OS versus surgery alone in cisplatin-ineligible patients, supporting Astellas’s Japan sNDA [5].

What is Elevar seeking with lirafugratinib?

FDA approval for second-line FGFR2-positive CCA based on ReFocus efficacy signals and manageable safety in FGFRi-naïve patients [9].

Entities/Keywords

Leronlimab, CCR5, TNBC; Paxalisib, PI3K/mTOR, pembrolizumab, TNBC; Bezuclastinib, sunitinib, KIT, GIST, PEAK; Tecentriq (atezolizumab), ctDNA, MRD, MIBC, IMvigor011; Enfortumab vedotin, PADCEV, Keytruda, EV-303/KEYNOTE-905; MCS-8 (PCP), cholesterol, LDH, prostate cancer prevention; AKEEGA (niraparib + abiraterone), AMPLITUDE, BRCA1/2, mHSPC; Zynyz (retifanlimab), SCAC, POD1UM-303/InterAACT2; Lirafugratinib (RLY-4008), FGFR2, cholangiocarcinoma; iSCIB1+, Immunobody, melanoma, SCOPE.