Oncology Today—January 26, 2026

LucidQuest

1 hour ago

This week’s Oncology update spans regulatory milestones, late-stage clinical readouts, imaging AI deployment, and access designations across oncology. Themes include expedited US pathways, pivotal trial results, and a major regional approval impacting treatment choices.

In Today’s Newsletter

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🧬 BNT113 gets FDA Fast Track in HPV16+ HNSCC [1] [US • 21 Jan 2026]

https://investors.biontech.de/news-releases/news-release-details/biontech-receives-fda-fast-track-designation-mrna-cancer
Context: Pivotal Phase 2/3 AHEAD-MERIT (NCT04534205) testing BNT113 + pembrolizumab vs pembrolizumab alone in first line.
Key point: FDA Fast Track for unresectable recurrent or metastatic HPV16+ PD-L1+ HNSCC, based on preliminary safety and efficacy.
Implication: May influence prescriber choice and payer reviews pending full data.

🤝 BMS teams with Microsoft on AI early lung cancer detection [2] [US • 20 Jan 2026]

https://news.bms.com/news/corporate-financial/2026/Bristol-Myers-Squibb-Announces-Collaboration-with-Microsoft-to-Advance-AI-Driven-Early-Detection-of-Lung-Cancer/default.aspx
Context: FDA-cleared radiology algorithms deployed via Microsoft Precision Imaging Network used across US hospitals.
Key point: Workflow aims to surface lung nodules on X-ray and CT and improve follow-up, focusing on underserved settings.
Implication: May expand screening, initiation, and follow-up at scale.

📄 FDA accepts Celcuity NDA for gedatolisib, Priority Review [3] [US • 20 Jan 2026]

https://ir.celcuity.com/news-releases/news-release-details/celcuity-announces-fda-acceptance-new-drug-application Context: NDA under RTOR, supported by VIKTORIA-1 PIK3CA wild-type cohort.
Key point: Acceptance with Priority Review for HR+/HER2-, PIK3CA wild-type advanced breast cancer, PDUFA 17 Jul 2026.
Implication: May influence prescriber choice and payer reviews pending full data.

📰 NEJM: Trodelvy + Keytruda improves PFS in 1L PD-L1+ mTNBC [4] [US • 20 Jan 2026]

https://www.businesswire.com/news/home/20260120151830/en/New-England-Journal-of-Medicine-Publishes-Phase-3-ASCENT-04KEYNOTE-D19-Results-Supporting-Trodelvy-Plus-Keytruda-as-a-Potential-New-Standard-of-Care-in-First-line-PD-L1-Metastatic-Triple-negative-Breast-Cancer
Context: Phase 3 ASCENT-04/KEYNOTE-D19, n=443, safety consistent with each agent.
Key point: 35% reduced risk of progression or death vs Keytruda + chemotherapy, median PFS 11.2 vs 7.8 months.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Cogent to submit bezuclastinib NDA under RTOR for GIST [5] [US • 20 Jan 2026]

https://investors.cogentbio.com/news-releases/news-release-details/cogent-biosciences-initiate-new-drug-application-nda-submission
Context: PEAK trial in imatinib-pretreated GIST vs sunitinib monotherapy.
Key point: FDA agreed to RTOR; PEAK showed PFS HR 0.50, mPFS 16.5 vs 9.2 months, ORR 46% vs 26%.
Implication: May influence prescriber choice and payer reviews pending full data.

🇨🇳 ENHERTU approved in China for 2L HER2+ gastric or GEJ cancer [6] [China • 22 Jan 2026]

https://www.daiichisankyo.com/files/news/pressrelease/pdf/202601/20260122_E2.pdf
Context: DESTINY-Gastric04 showed OS benefit; CDE Breakthrough Therapy and Priority Review enabled rapid approval.
Key point: First and only HER2-directed ADC approved in China for second line gastric or GEJ, OS HR 0.70, median OS 14.7 vs 11.4 months.
Implication: Introduces competition that may affect pricing and formulary access.

🌸 Lilly FRα ADC gets Breakthrough in platinum-resistant ovarian cancer [7] [US • 20 Jan 2026]

https://investor.lilly.com/news-releases/news-release-details/lillys-sofetabart-mipitecan-receives-us-fdas-breakthrough
Context: Phase 1 signals across FRα expression; Phase 3 FRAmework-01 initiated.
Key point: Breakthrough Therapy designation for sofetabart mipitecan after bevacizumab and mirvetuximab soravtansine.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 Moderna–Merck: 5-year RFS benefit with INT + Keytruda in melanoma [8] [US • 20 Jan 2026]

https://www.merck.com/news/moderna-merck-announce-5-year-data-for-intismeran-autogene-in-combination-with-keytruda-pembrolizumab-demonstrated-sustained-improvement-in-the-primary-endpoint-of-recurrence-free-survival-i/
Context: Adjuvant Phase 2b KEYNOTE-942/mRNA-4157-P201 in resected high-risk stage III or IV melanoma.
Key point: 49% reduction in recurrence or death vs Keytruda alone (HR 0.510, nominal p=0.0075), safety consistent.
Implication: May influence prescriber choice and payer reviews pending full data.

🧑‍🔬 ICRF + CRI co-fund grant on TIL resistance in melanoma [9] [US • 22 Jan 2026]

https://www.prnewswire.com/news-releases/israel-cancer-research-fund-and-cancer-research-institute-announce-co-funding-of-grant-to-address-immunotherapy-resistance-in-melanoma-302667296.html
Context: $180,000 over three years to Asaf Madi, PhD, Tel Aviv University, to refine TIL selection and expansion.
Key point: Project targets predictive biomarkers and resistance mechanisms to improve TIL therapy durability.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧪 Lantern’s LP-284 gains FDA Orphan Drug Designation in soft tissue sarcoma [10] [US • 20 Jan 2026]

https://ir.lanternpharma.com/news-1/news/news-details/2026/Lantern-Pharmas-LP-284-Receives-FDA-Orphan-Drug-Designation-for-Soft-Tissue-Sarcomas/default.aspx
Context: Third orphan for LP-284, with ongoing Phase 1 in B-cell NHL (NCT06132503).
Key point: Orphan Drug Designation extends program to solid tumors with DNA repair defects aligned to LP-284’s synthetic-lethal mechanism.
Implication: Introduces competition that may affect pricing and formulary access.

Why it Matters

Accelerated US pathways, including Fast Track, Breakthrough, RTOR, and ODD, are clustering around oncology assets with early efficacy signals.
ADCs show continued momentum with randomized advantages and regional approvals across breast, gastric, ovarian, and GIST.
Imaging AI collaborations aim to operationalize earlier detection and structured follow-up in lung cancer.
Individualized neoantigen therapy shows durable adjuvant benefit signals, reinforcing IO combination strategies.

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FAQ

What is BNT113 and where is it in development? [1]

BNT113 is an mRNA immunotherapy encoding HPV16 E6 and E7. It is in a pivotal Phase 2 or 3 with pembrolizumab versus pembrolizumab alone in first-line unresectable recurrent or metastatic HPV16+ PD-L1+ HNSCC. FDA granted Fast Track on 21 Jan 2026.

Which Celcuity population is covered by the NDA? [3]

HR+/HER2-, PIK3CA wild-type advanced breast cancer. The NDA was accepted with Priority Review, PDUFA 17 Jul 2026, supported by the VIKTORIA-1 PIK3CA wild-type cohort.

What did ASCENT-04/KEYNOTE-D19 show for Trodelvy + Keytruda? [4]

In first-line PD-L1+ metastatic TNBC, the combination reduced risk of progression or death by 35% versus Keytruda + chemotherapy, with median PFS 11.2 vs 7.8 months, and no new safety signals.

What is bezuclastinib’s regulatory plan in GIST? [5]

Cogent will submit an NDA under RTOR for bezuclastinib + sunitinib in imatinib-pretreated GIST, supported by PEAK trial results showing PFS HR 0.50 and higher ORR versus sunitinib.

What is ENHERTU’s new China approval scope? [6]

Second-line HER2+ metastatic gastric or GEJ adenocarcinoma after one trastuzumab-based regimen, based on DESTINY-Gastric04 OS benefit. Described as the first and only HER2-directed ADC in this setting in China.

Which setting did Lilly’s sofetabart mipitecan receive BTD for? [7]

Platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after bevacizumab and mirvetuximab soravtansine, supported by Phase 1 signals across FRα expression levels.

Entities/Keywords

BioNTech; BNT113; HPV16; HNSCC; AHEAD-MERIT • Bristol Myers Squibb; Microsoft; Precision Imaging Network; lung nodules • Celcuity; gedatolisib; VIKTORIA-1; RTOR; HR+/HER2-; PIK3CA wild-type • Gilead; Trodelvy; sacituzumab govitecan; Merck; Keytruda; ASCENT-04/KEYNOTE-D19; PD-L1+ mTNBC • Cogent Biosciences; bezuclastinib; sunitinib; PEAK; GIST; RTOR • Daiichi Sankyo; AstraZeneca; ENHERTU; trastuzumab deruxtecan; DESTINY-Gastric04; NMPA • Eli Lilly; sofetabart mipitecan; FRα ADC; PROC; FRAmework-01 • Moderna; Merck; intismeran autogene; mRNA-4157; KEYNOTE-942; adjuvant melanoma • Israel Cancer Research Fund; Cancer Research Institute; Asaf Madi; TIL therapy; melanoma • Lantern Pharma; LP-284; Orphan Drug Designation; soft tissue sarcoma.