Oncology Today — October 20, 2025

LucidQuest

3 weeks ago

Catch the latest Oncology news, featuring ESMO 2025 updates, FDA and EMA milestones, clinical progress, and biopharma innovations.

🧬 Bicara Therapeutics Announces Ficerafusp Alfa Granted Breakthrough Therapy Designation by U.S. FDA for 1L HPV-Negative R/M HNSCC [1] [US • 13 Oct 2025]

https://ir.bicara.com/news-releases/news-release-details/bicara-therapeutics-announces-ficerafusp-alfa-granted
Context: Supported by multiple Phase 1/1b dose cohorts and ongoing pivotal Phase 2/3 FORTIFI-HN01 (n≈650; co-primary ORR and OS).
Key point: FDA granted BTD for ficerafusp alfa with pembrolizumab in PD-L1 CPS ≥1, excluding HPV-positive oropharyngeal SCC.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Akamis Bio Receives FDA Fast Track Designation for NG-350A for the Treatment of Mismatch Repair-Proficient Locally Advanced Rectal Cancer [2] [[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 is enrolling pMMR LARC patients to NG-350A plus chemoradiotherapy; primary endpoint cCR at week 12 (n≈30).
Key point: FDA Fast Track granted to intravenously delivered oncolytic immunotherapy NG-350A in pMMR LARC.
Implication: Signals pipeline investment and modality expansion.

💊 Corcept Submits Marketing Authorization Application to European Medicines Agency for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer [3] [EU • 14 Oct 2025]

https://ir.corcept.com/news-releases/news-release-details/corcept-submits-marketing-authorization-application-european
Context: Based on Phase 3 ROSELLA and Phase 2 trials, relacorilant + nab-paclitaxel vs nab-paclitaxel alone.
Key point: EMA MAA filed citing improved PFS and OS with comparable safety to control.
Implication: Introduces competition that may affect pricing and formulary access.

🧠 TUKYSA Combination Significantly Improves Progression-Free Survival as First-Line Maintenance in HER2+ Metastatic Breast Cancer in HER2CLIMB-05 Trial [4] [14 Oct 2025]

https://www.pfizer.com/news/press-release/press-release-detail/tukysa-combination-significantly-improves-progression-free
Context: Randomized, double blind Phase 3 maintenance after taxane-based induction; safety consistent with individual agents.
Key point: Primary endpoint met, tucatinib + trastuzumab + pertuzumab improved investigator-assessed PFS vs placebo combo.
Implication: May influence prescriber choice and payer reviews pending full data.

🩺 Novartis Kisqali 5-year NATALEE data demonstrate 28% reduction in risk of recurrence in the broadest early breast cancer patient population [5] [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; distant DFS reduction 29.1%; OS trend favorable; no new safety signals.
Key point: Ribociclib + ET cut iDFS risk 28.4% vs ET alone across broad high-risk stage II–III HR+/HER2– EBC, including node-negative.
Implication: May influence prescriber choice and payer reviews pending full data.

🤝 Tempus Announces Collaboration with Whitehawk Therapeutics to Advance Biomarker-Driven Oncology Research [6] [16 Oct 2025]

https://www.businesswire.com/news/home/20251016398546/en/Tempus-Announces-Collaboration-with-Whitehawk-Therapeutics-to-Advance-Biomarker-Driven-Oncology-Research
Context: Multi-year use of de-identified multimodal RWD to inform ADC programs targeting PTK7, MUC16, SEZ6.
Key point: Collaboration aims to refine biomarker strategy, indication prioritization, and RNA vs IHC concordance.
Implication: Partnerships/BD: signals pipeline investment and modality expansion.

🔬 Capivasertib Combo Extends rPFS in PTEN-Deficient HSPC [7] [17 Oct 2025]

https://www.targetedonc.com/view/capivasertib-combo-extends-rpfs-in-pten-deficient-hspc
Context: CAPItello-281 final rPFS analysis in de novo mHSPC; higher grade ≥3 AEs with capivasertib; OS immature.
Key point: rPFS 33.2 months with capivasertib + abiraterone + prednisone + ADT vs 25.7 with placebo combo (HR 0.81).
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 Perioperative Durvalumab Maintains HRQOL in Muscle-Invasive BC [8] [19 Oct 2025]

https://www.oncnursingnews.com/view/perioperative-durvalumab-maintains-hrqol-in-muscle-invasive-bc
Context: NIAGARA HRQOL analyses used EORTC QLQ-C30 and EQ-5D-5L; similar compliance and scores between arms.
Key point: Adding perioperative durvalumab to neoadjuvant GC and adjuvant durvalumab did not worsen HRQOL vs GC alone.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧪 ESMO 2025: GFH375 Shows Potential Against KRAS G12D Pancreatic Tumours [9] [19 Oct 2025]

https://www.emjreviews.com/oncology/news/esmo-2025-gfh375-shows-potential-against-kras-g12d-pancreatic-tumours/
Context: Ongoing Phase I/II in heavily pretreated KRAS G12D PDAC; early follow-up; manageable safety reported.
Key point: Reported interim ORR 41% and DCR 97%; 3-month PFS 83% in KRAS G12D-mutant PDAC.
Implication: May influence prescriber choice and payer reviews pending full data.

🧔 ESMO 2025: Final Results from PRESTO (AFT-19): A Phase 3 Open-label Study of Combined Androgen Blockade in Patients with High-risk Biochemically Relapsed Prostate Cancer [10] [19 Oct 2025]

https://www.urotoday.com/conference-highlights/esmo-2025/esmo-2025-prostate-cancer/164091-esmo-2025-final-results-from-presto-aft-19-a-phase-3-open-label-study-of-combined-androgen-blockade-in-patients-with-high-risk-biochemically-relapsed-prostate-cancer.html
Context: Randomized open-label Phase 3, 503 patients, median follow-up 61 months; metastasis-directed therapy not permitted until PSA progression.
Key point: ADT + apalutamide improved MFS, time to castration resistance, and time to subsequent therapy vs ADT; adding abiraterone did not add benefit and increased toxicity.
Implication: May influence prescriber choice and payer reviews pending full data.

Why It Matters

Demonstrates regulatory momentum in solid tumors, from BTD and Fast Track to EMA submissions and positive Phase 3 readouts.
Breast-cancer standards may shift with tucatinib maintenance and durable adjuvant ribociclib benefit across broad risk groups.
Biology-led strategies, such as capivasertib in PTEN-deficient mHSPC and KRAS G12D targeting in PDAC, refine patient selection.
HRQOL neutrality with perioperative durvalumab supports adoption alongside efficacy.
Data partnerships underscore the role of multimodal RWD in ADC pipeline design and biomarker strategy.

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FAQ

What did FDA’s BTD for ficerafusp alfa cover? [1]

Answer: Ficerafusp alfa plus pembrolizumab in 1L HPV-negative R/M HNSCC with PD-L1 CPS ≥1, supported by Phase 1/1b data and the FORTIFI-HN01 pivotal study.

Is NG-350A close to registration? [2]

Answer: Not yet. It holds Fast Track and is in a Phase 1b single-arm trial with cCR at week 12 as the primary endpoint in pMMR LARC.

What supports Corcept’s EMA MAA for relacorilant? [3]

Answer: Phase 3 ROSELLA and Phase 2 studies where relacorilant + nab-paclitaxel improved PFS and OS over nab-paclitaxel alone, with similar safety.

How practice-changing is HER2CLIMB-05 for tucatinib? [4]

Answer: Topline shows PFS benefit for tucatinib added to trastuzumab + pertuzumab as 1L maintenance in HER2+ MBC; full data and OS will guide adoption.

What is the key takeaway from NATALEE’s 5-year update? [5]

Answer: Ribociclib + ET sustained iDFS benefit, including in node-negative patients, with no new safety signals and an encouraging OS trend.

What is notable about the capivasertib HSPC data? [7]

Answer: rPFS improved by 7.5 months in PTEN-deficient de novo mHSPC; OS is immature and toxicity was higher with capivasertib.

Does perioperative durvalumab affect quality of life? [8]

Answer: NIAGARA HRQOL analyses showed no meaningful deterioration vs chemotherapy alone.

How strong is the early KRAS G12D signal for GFH375? [9]

Answer: Interim ORR 41% and DCR 97% with manageable safety in heavily pretreated PDAC, though follow-up is short.

What did PRESTO conclude for intermittent therapy in BCR prostate cancer? [10]

Answer: Finite ADT + apalutamide improved key long-term endpoints vs ADT alone; adding abiraterone offered no added benefit and more toxicity.

Entities / Keywords

Ficerafusp alfa; Bicara Therapeutics; pembrolizumab; HPV-negative HNSCC; FORTIFI-HN01; NG-350A; Akamis Bio; pMMR LARC; FORTRESS; Relacorilant; Corcept; platinum-resistant ovarian cancer; ROSELLA; Tucatinib; TUKYSA; Pfizer; HER2CLIMB-05; HER2+ MBC; Ribociclib; Kisqali; Novartis; NATALEE; HR+/HER2– EBC; Tempus; Whitehawk Therapeutics; ADCs; PTK7; MUC16; SEZ6; RWD; Capivasertib; Truqap; abiraterone; PTEN-deficient de novo mHSPC; CAPItello-281; Durvalumab; NIAGARA; muscle-invasive bladder cancer; HRQOL; GFH375; KRAS G12D; PDAC; PRESTO; ADT; apalutamide; abiraterone; biochemically relapsed prostate cancer.