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- Week 24–30 November 2025
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Top Stories Covered in This Video
Chapters
0:00 Introduction
0:08 FDA Fast Track for AVZO-103 Nectin4–TROP2 bispecific ADC in post–enfortumab urothelial cancer
0:31 Swissmedic approval of lurbinectedin plus atezolizumab as first-line maintenance in ES-SCLC after ACE induction
1:09 Imfinzi plus FLOT approved as first perioperative immunotherapy for resectable stage II–IVA gastric and GEJ cancers
1:47 Sacituzumab tirumotecan Phase 2 monotherapy shows 31 percent ORR in heavily pretreated urothelial cancer
2:37 Astrin Biosciences launches Certitude Breast blood-based early detection test with 92 percent sensitivity and 93 percent specificity 3:13 S1609 DART nivolumab plus ipilimumab shows similar benefit with or without prior PD-1 or PD-L1 exposure in rare cancers
4:02 FDA clears FOLR1 CAR T trial for relapsed or refractory osteosarcoma NCT07227571 enrolling ages 1–75
4:30 Evorpacept plus rituximab and lenalidomide achieves 92 percent CR and 100 percent ORR in frontline indolent B-cell NHL
5:08 How to reach us
Transcript
Welcome to the latest edition of Oncology Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.
The FDA granted Fast Track to AVZO-103, a Nectin4 and TROP2 bispecific antibody drug conjugate, for adults with locally advanced or metastatic urothelial cancer previously treated with enfortumab vedotin. This targets a post–enfortumab setting with no approved ADCs.
Swissmedic approved lurbinectedin plus atezolizumab as first line maintenance for extensive stage small cell lung cancer without CNS metastases after induction with atezolizumab, carboplatin, etoposide. IMforte reduced risk of progression or death by 46 percent and death by 27 percent versus atezolizumab alone. Median overall survival 13.2 vs 10.6 months and progression free survival 5.4 vs 2.1 months, with safety consistent.
Imfinzi, durvalumab, plus FLOT was approved as the first perioperative immunotherapy for resectable stage II–IVA gastric and gastroesophageal junction cancers. MATTERHORN showed event free survival HR 0.71 and overall survival HR 0.78 versus FLOT, benefits regardless of PD L1, with similar rates of grade 3 or higher adverse events. Sequence: neoadjuvant Imfinzi with FLOT, adjuvant Imfinzi with FLOT, then Imfinzi monotherapy.
Phase 2 monotherapy of sacituzumab tirumotecan at 5 mg per kg every two weeks in metastatic urothelial cancer after chemotherapy and checkpoint inhibitors. Among 49 patients, confirmed objective response rate was 31 percent overall, 50 percent in second line, disease control rate 71 percent, median progression free survival 5.5 months, and median duration of response not reached with a 53 percent probability of sustained response at 12 months. Safety was manageable, mainly hematologic toxicities and stomatitis, no febrile neutropenia, and no grade 5 treatment related adverse events.
Astrin Biosciences launched Certitude Breast, a non imaging, blood based early detection test using deep proteomics and artificial intelligence. In a study of 1,242 women, sensitivity was 92 percent and specificity 93 percent across stages and subtypes, with negative predictive value greater than 99.9 percent. Positioned as a supplemental option, especially for women with dense breasts where imaging has limitations and higher false positive rates.
The NCI and SWOG S1609 DART basket trial tested nivolumab 240 mg every two weeks plus ipilimumab 1 mg per kg every six weeks in rare cancers, allowing prior anti PD 1 or PD L1 therapy. Clinical benefit rate was 26 percent in both those with and without prior exposure, with no significant differences in progression free survival, multivariable hazard ratio 1.18 with 95 percent confidence interval 0.83 to 1.68, or overall survival, hazard ratio 1.11 with 95 percent confidence interval 0.76 to 1.63.
The FDA cleared a trial of FOLR1 CAR T for relapsed or refractory osteosarcoma, NCT07227571, enrolling ages 1 to 75. First used in infants with CBF or GLIS acute myeloid leukemia, the platform may expand to other FOLR1 positive malignancies based on expression and preclinical efficacy.
An investigator sponsored phase 2 at MD Anderson added the CD47 blocker evorpacept to rituximab and lenalidomide in previously untreated indolent B cell NHL, follicular and marginal zone. In 24 patients, complete responses were 92 percent and partial responses 8 percent, overall response rate 100 percent. One year progression free survival was 91 percent and one year overall survival 100 percent, well tolerated in a frontline, non chemotherapy setting.
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Why It Matters
- Post–enfortumab urothelial cancer: AVZO-103 and sac-TMT underscore how ADCs are moving into resistant UC, potentially redefining lines of therapy.
- ES-SCLC maintenance: Swissmedic’s decision sets a precedent for lurbinectedin + atezolizumab as a more active maintenance backbone.
- Perioperative IO in GI: Imfinzi + FLOT shifts the standard in early gastric/GEJ cancers toward integrated IO from diagnosis through surgery.
- Screening innovation: Certitude Breast exemplifies how proteomics + AI may complement imaging, especially for women with dense breasts.
- IO sequencing & eligibility: S1609/DART provides real-world-like evidence to keep PD-1/L1-pretreated patients eligible for combo IO trials.
- Next-gen immunotherapies: FOLR1-CART and evorpacept combinations highlight parallel advances in cellular and myeloid-targeting IO strategies.
🗓️ Explore weekly details and sources
- Week 24–30 November 2025
- Week 1–7 November 2025
📚 See the full Oncology archive on our research hub page.
FAQ
What did FDA grant to AVZO-103 and for which patients?
Fast Track designation for AVZO-103 in adults with locally advanced or metastatic urothelial cancer previously treated with enfortumab vedotin, where no approved ADCs currently exist [1].
What exactly did Swissmedic approve in ES-SCLC and on what data?
Zepzelca (lurbinectedin) + atezolizumab as first-line maintenance for ES-SCLC without CNS metastases whose disease has not progressed after induction with atezolizumab, carboplatin, and etoposide, based on IMforte risk reductions in PFS and OS vs atezolizumab maintenance alone [2].
What defines the new Imfinzi perioperative regimen in gastric/GEJ cancers?
Neoadjuvant Imfinzi + FLOT before surgery, followed by adjuvant Imfinzi + FLOT, then Imfinzi monotherapy, with MATTERHORN showing significant improvements in EFS and OS vs FLOT alone [3].
What were the key efficacy signals for sac-TMT in UC?
In heavily pretreated advanced/metastatic UC, sac-TMT 5 mg/kg Q2W achieved a 31% ORR (50% second-line), 71% DCR, median PFS 5.5 months, and durable responses with a manageable safety profile [4].
How might Certitude change screening for women with dense breasts?
With 92% sensitivity, 93% specificity, and NPV >99.9%, Certitude offers a blood-based supplemental option that may reduce unnecessary imaging and biopsies and help close gaps in detection for dense-breast populations [5].
Does prior PD-1/L1 exposure preclude benefit from nivolumab + ipilimumab in rare cancers?
In S1609/DART, clinical benefit, PFS, and OS were similar regardless of prior PD-1/L1 exposure, suggesting such patients can reasonably be included in future nivo + ipi trials [6].
What is the status of FOLR1-CART in osteosarcoma and who can enroll?
FDA has cleared a trial of FOLR1-CART for relapsed/refractory osteosarcoma (NCT07227571) enrolling patients 1–75 years old, with future expansion to other FOLR1-positive malignancies anticipated [7].
What did evorpacept add to R2 in frontline indolent B-cell NHL?
The addition of evorpacept to rituximab + lenalidomide produced a 92% CR rate and 100% ORR with encouraging 1-year PFS and OS, exceeding historical CR rates for R2 alone [8].
Entities / Keywords
Avenzo Therapeutics; AVZO-103; Nectin4/TROP2 bispecific ADC; urothelial carcinoma; post-enfortumab.
PharmaMar; Zepzelca; lurbinectedin; atezolizumab; Tecentriq; ES-SCLC; IMforte; Swissmedic.
AstraZeneca; Imfinzi; durvalumab; FLOT; MATTERHORN; perioperative; gastric cancer; GEJ cancer.
Kelun-Biotech; sacituzumab tirumotecan; sac-TMT; TROP2 ADC; urothelial carcinoma; MK-2870-001; KL264-01.
Astrin Biosciences; Certitude Breast; deep proteomics; AI classifier; dense breasts; SABCS.
NCI; SWOG; S1609; DART; nivolumab; ipilimumab; rare cancers; prior PD-1/L1 exposure.
Fred Hutch; FOLR1-CART; osteosarcoma; CBF/GLIS AML; NCT07227571.
ALX Oncology; evorpacept (ALX148); rituximab; lenalidomide; R2; indolent B-cell NHL; follicular lymphoma; marginal zone lymphoma.
References
- https://avenzotx.com/press-releases/avenzo-therapeutics-granted-fast-track-designation-for-avzo-103-a-potential-best-in-class-nectin4-trop2-bispecific-antibody-drug-conjugate-for-the-treatment-of-patients-with-urothelial-cancer-previo/
- https://pharmamar.com/en/swiss-medical-authority-approves-pharmamars-zepzelca-lurbinectedin-and-atezolizumab-tecentriq-combination-as-first-line-maintenance-therapy-for-extensive-stage-small-cell-lung/
- https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-us-as-first-and-only-perioperative-immunotherapy-for-patients-with-early-gastric-and-gastroesophageal-cancers.html
- https://www.prnewswire.com/apac/news-releases/the-annals-of-oncology-publishes-results-of-phase-ii-study-of-sacituzumab-tirumotecan-monotherapy-for-urothelial-carcinoma-302627886.html
- https://uk.finance.yahoo.com/news/astrin-biosciences-launches-certitude-breast-154200645.html
- https://ascopubs.org/doi/10.1200/OA-25-00110
- https://oncodaily.com/voices/soheil-meshinchi-420814
- https://www.globenewswire.com/news-release/2025/12/07/3201128/0/en/ALX-Oncology-Announces-Positive-Results-from-Ongoing-Investigator-Sponsored-Phase-2-Trial-Evaluating-Evorpacept-in-Combination-with-Standard-of-Care-Treatment-in-Patients-with-Indo.html