Oncology Video Recap — October 27, 2025

In this biweekly edition, we cover the most significant developments shaping the future of oncology — from scientific advances to industry and regulatory milestones.

Watch Our Video Summary Capturing Top Public Health News from the Last Two Weeks

Top Stories Covered in This Video

🧬 Ficerafusp Alfa Gains FDA Breakthrough Therapy in 1L HPV-Negative HNSCC [1] [US • 13 Oct 2025]

https://ir.bicara.com/news-releases/news-release-details/bicara-therapeutics-announces-ficerafusp-alfa-granted
Context: Supported by Phase 1/1b results showing median DoR 21.7 months and OS 21.3 months; pivotal Phase 2/3 FORTIFI-HN01 underway.
Key point: FDA granted BTD to ficerafusp alfa + pembrolizumab for first-line PD-L1 CPS ≥1 HPV-negative R/M HNSCC (HPV-positive oropharyngeal excluded).
Implication: May influence prescriber choice and payer reviews pending full data.

🍁 LOQTORZI Approved by Health Canada for Nasopharyngeal Carcinoma [2] [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: First and only approved immunotherapy for NPC in Canada; Apotex’s first biologic launch under license from Coherus BioSciences.
Key point: Health Canada issued NOC for LOQTORZI (toripalimab) for metastatic or recurrent locally advanced NPC, both combination and monotherapy indications.
Implication: Introduces competition that may affect pricing and formulary access.

🧠 FDA Fast Track for MT-125 in Glioblastoma [3] [US • 22 Oct 2025]

https://myosintherapeutics.com/myosin-therapeutics-receives-fda-fast-track-designation-for-mt-125-in-glioblastoma/
Context: Orphan Drug Designation previously granted; Phase 1/2 safety and PK trial cleared (NCT07185880).
Key point: MT-125, a dual NMIIA/IIB inhibitor, received FDA Fast Track designation for glioblastoma.
Implication: Signals pipeline investment and modality expansion.

💊 Kisqali 5-Year NATALEE Data Show Sustained Recurrence Benefit [4] [17 Oct 2025]

https://www.novartis.com/news/media-releases/novartis-kisqali-5-year-natalee-data-demonstrate-28-reduction-risk-recurrence-broadest-early-breast-cancer-patient-population
Context: Median follow-up 58.4 months; OS trend HR 0.80; consistent benefit across subgroups; no new safety findings.
Key point: Kisqali + ET cut recurrence risk by 28.4% vs ET alone (HR 0.716) in stage II–III HR+/HER2- early breast cancer; 5-year iDFS 85.5% vs 81.0%.
Implication: May influence prescriber choice and payer reviews pending full data.

📈 Vepdegestrant PROs Confirm Clinical Benefit in ESR1-Mutated ER+/HER2- ABC [5] [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: Complements prior PFS improvement; NDA accepted and Fast Track granted by FDA.
Key point: VERITAC-2 Phase 3 PROs show vepdegestrant delayed QoL deterioration, pain, and functioning loss vs fulvestrant.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🇪🇺 Corcept Files EMA MAA for Relacorilant in Platinum-Resistant Ovarian Cancer [6] [EU • 14 Oct 2025]

https://ir.corcept.com/news-releases/news-release-details/corcept-submits-marketing-authorization-application-european Context: PFS and OS improvements observed vs nab-paclitaxel alone; FDA PROC PDUFA set for 11 Jul 2026.
Key point: EMA submission for relacorilant + nab-paclitaxel based on positive Phase 3 ROSELLA and Phase 2 data in platinum-resistant ovarian cancer.
Implication: Introduces competition that may affect pricing and formulary access.

🫁 KEYTRUDA ± QLEX + Padcev Under FDA Priority Review for MIBC [7] [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: Combination improved EFS by 60%, OS by 50%, and pCR by 48% vs surgery alone; PDUFA 07 Apr 2026.
Key point: FDA priority review for perioperative KEYTRUDA or KEYTRUDA QLEX with Padcev in cisplatin-ineligible MIBC, supported by KEYNOTE-905.
Implication: May influence prescriber choice and payer reviews pending full data.

📡 NG-350A Earns FDA Fast Track in Mismatch Repair-Proficient Rectal Cancer [8] [US • 15 Oct 2025]

https://www.biospace.com/press-releases/akamis-bio-receives-fda-fast-track-designation-for-ng-350a-for-the-treatment-of-mismatch-repair-proficient-locally-advanced-rectal-cancer
Context: Phase 1b FORTRESS trial recruiting; evaluating NG-350A + chemoradiotherapy, primary endpoint cCR at week 12.
Key point: NG-350A, an IV oncolytic immunotherapy driving intratumoral CD40 agonist expression, granted FDA Fast Track for pMMR LARC.
Implication: Signals pipeline investment and modality expansion.

Why It Matters

Breakthrough, Fast Track, and Priority Review designations highlight regulatory acceleration across multiple tumor types [1][3][7][8].
Kisqali’s 5-year NATALEE results reinforce adjuvant CDK4/6 inhibition as a maturing standard in early HR+/HER2- breast cancer [4].
Vepdegestrant PROs strengthen patient-centric evidence for selective ER degraders in ESR1-mutated disease [5].
Health Canada’s LOQTORZI approval marks expanded access in an ultra-rare NPC population [2].
Corcept’s dual US–EU filings and Merck’s perioperative immunotherapy strategy may reshape future oncology benchmarks [6][7].

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FAQ

What does the FDA Breakthrough Therapy Designation for ficerafusp alfa signify?

It reflects potential substantial improvement over existing therapy in HPV-negative R/M HNSCC, expediting development and review of the pivotal FORTIFI-HN01 trial [1].

How does LOQTORZI’s approval change NPC treatment in Canada?

LOQTORZI (toripalimab) is now the first and only immunotherapy approved for recurrent or metastatic NPC, available for both combo and monotherapy use [2].

What is unique about MT-125’s mechanism in glioblastoma?

MT-125 is a dual NMIIA/IIB inhibitor targeting tumor cell motility and proliferation, introducing a novel nontraditional GBM pathway [3].

What does NATALEE’s five-year update show for Kisqali?

Kisqali + ET sustained a 28% reduction in recurrence risk across broad HR+/HER2- early breast cancer populations with no new safety issues [4].

What patient-reported benefit did vepdegestrant show in VERITAC-2?

Vepdegestrant delayed deterioration in QoL and symptom domains versus fulvestrant, complementing prior efficacy data [5].

How is relacorilant positioned in ovarian cancer?

Corcept’s relacorilant + nab-paclitaxel improved PFS and OS in PROC without new safety signals, now under EMA and FDA review [6].

Why is Merck’s KEYNOTE-905 significant?

KEYTRUDA + Padcev combinations achieved EFS, OS, and pCR gains vs surgery alone, leading to FDA priority review [7].

What is Akamis Bio testing with NG-350A?

The FORTRESS trial is evaluating NG-350A + chemoradiotherapy in pMMR LARC, targeting improved complete response rates [8].

Entities / Keywords

Bicara Therapeutics; ficerafusp alfa; pembrolizumab; HPV-negative HNSCC. • Apotex; LOQTORZI; toripalimab; nasopharyngeal carcinoma. •
Myosin Therapeutics; MT-125; glioblastoma. • Novartis; Kisqali; ribociclib; NATALEE; HR+/HER2- early breast cancer. • Arvinas; Pfizer; vepdegestrant; VERITAC-2; ESR1-mutated ER+/HER2- advanced breast cancer. • Corcept Therapeutics; relacorilant; ROSELLA; platinum-resistant ovarian cancer. • Merck; KEYTRUDA; KEYTRUDA QLEX; Padcev; KEYNOTE-905; muscle-invasive bladder cancer. • Akamis Bio; NG-350A; pMMR; locally advanced rectal cancer; FORTRESS.