Oncology Video Recap—November 24, 2025

LucidQuest

6 days ago

Explore this week’s oncology biweekly video recap to learn about Fast Track and accelerated approvals, robust Phase 3 NDA filings, innovative CTAs for new delivery devices, important regulatory alignments, significant label expansions, and additional updates.

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Week 10-16 November 2025
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Transcript

Welcome to the latest edition of Oncology Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.

First, Avenzo Therapeutics received FDA Fast Track for AVZO-1418, an EGFR and her 3 bispecific antibody drug conjugate, for unresectable or metastatic NSCLC with EGFR exon 19 deletion or L858R after an EGFR TKI. The program is in a Phase 1 Phase 2 first in human open label study in advanced solid tumors, as monotherapy and in combinations. This may shape prescriber choice and payer reviews as data mature.

Next, Bayer’s HYRNUO, sevabertinib, secured US accelerated approval for adult patients with previously treated her 2 mutated non squamous NSCLC. The oral reversible her 2 tyrosine kinase domain inhibitor was approved following Priority Review, based on overall response rate and duration of response from SOHO 01, with confirmatory evidence pending. Expect new competition to influence pricing and formulary access.

Celcuity completed its NDA submission under Real Time Oncology Review for gedatolisib in HR positive, her 2 negative, PIK3CA wild type advanced breast cancer, supported by the Phase 3 VIKTORIA 1 PIK3CA wild type cohort. Reported progression free survival was 9.3 months for the triplet versus 2.0 months with fulvestrant, hazard ratio 0.24, and 7.4 months for the doublet versus 2.0 months, hazard ratio 0.33. If cleared, this could redirect treatment decisions in PIK3CA wild type disease.

In the United Kingdom, BetaGlue Therapeutics received MHRA approval of its clinical trial application for YntraDose in unresectable locally advanced pancreatic cancer. This early feasibility clinical investigation, the first study of the Y 90 microsphere in glue locoregional radiotherapy device, aims to start in Q1 2026. Outcomes will depend on study design and control of confounding.

ITM announced FDA acceptance of the NDA for 177Lu edotreotide, ITM 11, in gastroenteropancreatic neuroendocrine tumors, with a PDUFA date of 28 Aug 2026. The randomized open label Phase 3 COMPETE trial, n equals 309 in first to second line Grade 1 to 2 GEP NETs, met its primary endpoint and showed longer progression free survival and higher overall response rate versus everolimus. This may broaden radiopharmaceutical options pending full review.

Hamlet BioPharma reported written FDA feedback supporting a pivotal study design for Alpha1H in low risk non muscle invasive bladder cancer. There is alignment on population, complete response and durability endpoints, event free survival, central pathology, and standardized assessments, with CMC and protocol finalization next. The decision signals investment potential for this modality.

In Europe, the European Commission approved Libtayo, cemiplimab, as adjuvant therapy for patients with high risk cutaneous squamous cell carcinoma following surgery and radiation, based on the randomized placebo controlled Phase 3 C-POST trial. Treatment reduced recurrence or death by 68 percent versus placebo, hazard ratio 0.32, p less than 0.0001. This decision is expected to affect access and treatment sequencing.

Also in Europe, the Commission approved subcutaneous pembrolizumab, KEYTRUDA SC, for all adult EU indications. In the Phase 3 3475A D77 study, subcutaneous dosing showed comparable pharmacokinetics and consistent efficacy versus intravenous administration, both with chemotherapy in first line metastatic NSCLC. Administration takes approximately 1 to 2 minutes, which could streamline initiation, remote prescribing, and logistics.

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Why It Matters

EU access shifts, with Libtayo adjuvant CSCC and KEYTRUDA SC expanding settings and convenience.
US precision lung cancer options grow with HYRNUO after prior therapy.
Radiopharma momentum, with ITM’s NDA and BetaGlue’s UK CTA advancing targeted isotope approaches.
Breast cancer filing under RTOR positions multi-target PAM inhibition for PIK3CA-WT disease.
FDA design feedback may accelerate a neoadjuvant option in low-risk NMIBC.

🗓️ Explore weekly details and sources

Week 10-16 November 2025
Week 17–23 November 2025

📚 See the full Oncology archive on our research hub page.

FAQ

What did FDA grant to AVZO-1418 and for which patients?

Fast Track for EGFR exon 19 del or L858R NSCLC that progressed after an EGFR TKI, based on ongoing Phase 1/2 work [1].

How was HYRNUO approved and on what basis?

US accelerated approval for HER2-mutated non-squamous NSCLC after prior therapy, supported by ORR and DoR from SOHO-01; confirmatory data pending [2].

What supports Celcuity’s gedatolisib NDA under RTOR?

VIKTORIA-1 PIK3CA-WT cohort, with reported PFS and hazard ratios for triplet and doublet vs fulvestrant; endpoints as stated in the source [3].

What is the regulatory status of ITM-11 for GEP-NETs?

FDA accepted the NDA with a PDUFA date of 28 Aug 2026; COMPETE met its primary endpoint vs everolimus and showed higher ORR [5].

What changed for Libtayo and KEYTRUDA in Europe?

EC approved Libtayo as adjuvant therapy in high-risk CSCC with a DFS benefit, and approved KEYTRUDA SC across all adult indications with comparable PK to IV [7][8].

What did MHRA and FDA provide to BetaGlue and Hamlet?

MHRA approved BetaGlue’s UK CTA for YntraDose in unresectable LA-PDAC, and FDA provided pivotal-design alignment for Alpha1H in low-risk NMIBC [4][6].

Entities / Keywords

Avenzo Therapeutics; AVZO-1418; EGFR/HER3 bispecific ADC; NSCLC.
Bayer; HYRNUO; sevabertinib; HER2 TKD mutations; NSCLC.
Celcuity; gedatolisib; PAM pathway; VIKTORIA-1; HR+/HER2-; PIK3CA-WT.
BetaGlue Therapeutics; YntraDose; Y-90 microspheres; LA-PDAC; MHRA CTA.
ITM Isotope Technologies Munich; 177Lu-edotreotide; ITM-11; COMPETE; GEP-NETs; PDUFA.
Hamlet BioPharma; Alpha1H; NMIBC; FDA pivotal design.
Regeneron; Libtayo; cemiplimab; C-POST; adjuvant CSCC; EC approval.
Merck, MSD; KEYTRUDA; pembrolizumab; KEYTRUDA SC; 3475A-D77; subcutaneous.