Oncology Today — October 27, 2025

This week’s oncology update spotlights key developments, clinical updates, and the latest progress shaping the biopharma landscape.

In this newsletter

🧠 Safusidenib Phase 3 enrollment begins in high-grade glioma [1] [US • 23 Oct 2025]

https://investors.nuvationbio.com/news/news-details/2025/Nuvation-Bio-Enrolls-First-Patient-in-Global-Randomized-Study-of-Safusidenib-for-Maintenance-Treatment-of-High-Grade-IDH1-Mutant-Glioma/default.aspx
Context: Global G203 study (NCT05303519) now a randomized Phase 3 with ≈300 patients in the US, Australia, and China.
Key point: Primary endpoint = PFS by BICR; FDA confirmed it can support approval.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 MT-125 earns FDA Fast Track in glioblastoma [2] [US • 22 Oct 2025]

https://myosintherapeutics.com/myosin-therapeutics-receives-fda-fast-track-designation-for-mt-125-in-glioblastoma/
Context: MT-125, a dual non-muscle myosin IIA/IIB inhibitor, introduces a novel GBM mechanism; Phase 1/2 (NCT07185880) cleared to proceed.
Key point: Fast Track enables frequent FDA engagement and rolling review.
Implication: May influence prescriber choice and payer reviews pending full data.

🍁 LOQTORZI approved in nasopharyngeal cancer [3] [CA • 23 Oct 2025]

https://www.apotex.com/global/news/news-release/2025/10/23/apotex-receives-health-canada-approval-for-loqtorzi-the-first-and-only-immuno-therapy-for-recurrent-unresectable-or-metastatic-nasopharyngeal-cancer
Context: Health Canada granted NOC for toripalimab (LOQTORZI) ± cisplatin/gemcitabine in recurrent/metastatic NPC.
Key point: First and only immunotherapy approved in Canada for this cancer.
Implication: Introduces competition that may affect pricing and formulary access.

🧪 Zocilurtatug pelitecan (zoci) Phase 1 update in SCLC [4] [US/EU/CN • 24 Oct 2025]

https://ir.zailaboratory.com/news-releases/news-release-details/zai-lab-announces-updated-phase-1-data-zocilurtatug-pelitecan
Context: 115-patient Phase 1 trial; 68% ORR in 1.6 mg/kg second-line cohort; 80% ORR in baseline brain metastases (no prior RT).
Key point: Manageable safety (13% Grade ≥3 TRAEs at 1.6 mg/kg); Phase 3 registrational study (NCT07218146) under way.
Implication: May influence prescriber choice and payer reviews pending full data.

🌬️ Ateganosine (THIO) 30-month survival reported in NSCLC [5] [EU • 23 Oct 2025]

https://ir.maiabiotech.com/news-events/press-releases/detail/155/maia-biotechnology-details-30-month-patient-survival-in
Context: Phase 2 THIO-101 trial showed a patient surviving 30 months post-treatment; presented at ESMO 2025.
Key point: Ateganosine targets telomerase-positive NSCLC cells and activates immune memory.
Implication: May influence prescriber choice and payer reviews pending full data.

💊 Vepdegestrant improves quality-of-life in VERITAC-2 [6] [EU • 20 Oct 2025]

https://www.globenewswire.com/news-release/2025/10/20/3169130/0/en/Patient-Reported-Outcomes-from-VERITAC-2-Clinical-Trial-Support-Clinical-Benefit-of-Vepdegestrant-in-Patients-with-ESR1-Mutated-ER-HER2-Advanced-or-Metastatic-Breast-Cancer-Previou.html
Context: Phase 3 VERITAC-2 trial (Arvinas + Pfizer) in ESR1-mutated ER+/HER2– advanced breast cancer.
Key point: Patients on vepdegestrant had delayed QoL decline and symptom worsening vs fulvestrant.
Implication: May influence prescriber choice and payer reviews pending full data.

🫁 TEVIMBRA data strengthen PD-1 base; HPK1 combo early results [7] [EU • 20 Oct 2025]

https://ir.beonemedicines.com/news/beone-medicines-presents-new-data-on-tevimbra-in-lung-cancer-at-esmo-2025/d1b7d5b3-003f-4ab3-9d82-f9480194a258
Context: RATIONALE-307 and 312 Phase 3 data support TEVIMBRA (tislelizumab) in NSCLC and ES-SCLC; HPK1 inhibitor combo shows early antitumor activity.
Key point: Durable OS benefit in lung cancers; no new safety signals reported.
Implication: May influence prescriber choice and payer reviews pending full data.

💉 KEYTRUDA + Padcev perioperative combo gets Priority Review for MIBC [8] [US • 23 Oct 2025]

https://www.merck.com/news/fda-grants-priority-review-for-keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-in-combination-with-padcev-enfortumab-vedotin-ejfv/
Context: sBLAs for KEYTRUDA and KEYTRUDA QLEX combos in cisplatin-ineligible MIBC patients.
Key point: Phase 3 KEYNOTE-905 cut EFS risk by 60% and death risk by 50% vs surgery alone.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 XmAb819 first-in-class ENPP3 x CD3 data in renal cell cancer [9] [US • 24 Oct 2025]

https://investors.xencor.com/news-releases/news-release-details/xencor-presents-initial-data-xmab819-first-class-enpp3-x-cd3
Context: Phase 1 dose-escalation study in advanced ccRCC (69 patients across 15 cohorts).
Key point: 25% ORR and 70% disease-control within target dose range; well-tolerated.
Implication: May influence prescriber choice and payer reviews pending full data.

🧩 VS-7375 shows early KRAS G12D activity in solid tumors [10] [US • 23 Oct 2025]

https://investor.verastem.com/news-releases/news-release-details/verastem-oncology-announces-encouraging-preliminary-data-ongoing
Context: First two monotherapy dose levels (400 mg QD, 600 mg QD) cleared with no DLTs in Phase 1/2a trial (VS-7375-101).
Key point: Tumor reductions seen in 4/5 evaluable patients; combination with cetuximab now enrolling.
Implication: May influence prescriber choice and payer reviews pending full data.

Why It Matters

Multiple brain tumor programs (safusidenib, MT-125) target previously untreatable IDH1-mutant and GBM populations.
Regulatory acceleration continues: Fast Track, Priority Review, and new approvals expand access.
Modality diversification—ADCs, bispecifics, telomere-targeted and PROTAC agents—signals deep innovation in oncology R&D.
ESMO 2025 reinforced global oncology momentum across lung, breast, and rare tumor types.

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FAQ

What distinguishes Nuvation Bio’s safusidenib trial?

It is the first global Phase 3 maintenance study in high-grade IDH1-mutant glioma with FDA-agreed PFS endpoint [1].

How is MT-125 (Myosin Therapeutics) unique?

A first-in-class dual NMIIA/IIB inhibitor that targets cellular motors driving GBM invasion [2].

Why is LOQTORZI’s Health Canada approval important?

It introduces the first immunotherapy for recurrent/metastatic nasopharyngeal carcinoma in Canada [3].

What are Zai Lab’s zocilurtatug pelitecan results?

Strong responses (68% ORR) and low toxicity support its DLL3-ADC potential in small cell lung cancer [4].

What milestone did MAIA Biotechnology report?

A 30-month survival in Phase 2 ateganosine trial in third-line NSCLC [5].

What patient benefits did Arvinas see with vepdegestrant?

Patients experienced statistically significant delays in quality-of-life decline vs fulvestrant [6].

How does BeOne’s TEVIMBRA data fit into current standards?

It extends evidence for tislelizumab across NSCLC and SCLC with durable efficacy [7].

What is Merck’s KEYTRUDA Priority Review about?

It covers perioperative KEYTRUDA/Padcev in cisplatin-ineligible MIBC, first to show survival gain [8].

What progress did Xencor report for XmAb819?

Early renal cell data show 25% ORR with manageable CRS and rash profile [9].

What early signal does Verastem’s VS-7375 show?

Initial responses in KRAS G12D-mutant pancreatic and NSCLC tumors, expanding to combination cohorts [10].

Entities / Keywords

Nuvation Bio; safusidenib; IDH1-mutant glioma; Myosin Therapeutics; MT-125; glioblastoma; Apotex; LOQTORZI; toripalimab; nasopharyngeal carcinoma; Zai Lab; zocilurtatug pelitecan; DLL3 ADC; small cell lung cancer; MAIA Biotechnology; ateganosine (THIO); non-small cell lung cancer; Arvinas; Pfizer; vepdegestrant; BeOne Medicines; TEVIMBRA (tislelizumab); HPK1 inhibitor; Merck; KEYTRUDA; Padcev; bladder cancer; Xencor; XmAb819; ENPP3 x CD3; Verastem Oncology; VS-7375; KRAS G12D.