What's next in obstetrics and gynecology — October 22, 2026

This edition covers what is coming in obstetrics and gynecology between late October 2026 and March 2027: two phase 3 endometrial cancer trials in the ESMO 2026 presidential symposium, the European decision on a new PARP inhibitor for first-line ovarian maintenance, the FDA priority review of elinzanetant for hot flashes induced by breast cancer endocrine therapy, and the March SGO and SMFM meetings. For each item we state whether the date is confirmed or estimated.

1. Sacituzumab tirumotecan and pembrolizumab in endometrial cancer at the ESMO 2026 presidential symposium

[Congress] [Europe (Madrid); multinational trials] [Confirmed date: October 23–27, 2026 (congress); the exact session day is not stated in the official release]
What it is: TroFuse-005 (NCT06132958; LBA11) randomized 776 patients with advanced or recurrent endometrial carcinoma or carcinosarcoma, after platinum and anti-PD-1/PD-L1 therapy, to sacituzumab tirumotecan (an anti-TROP2 antibody-drug conjugate) versus physician's choice of doxorubicin or paclitaxel; per Merck, it met both primary endpoints (overall survival and progression-free survival) in certain patients with advanced or recurrent endometrial cancer, at a pre-specified interim analysis (release of May 18, 2026). The same session features KEYNOTE-C93 (LBA12): pembrolizumab monotherapy versus carboplatin-paclitaxel as first-line treatment for advanced or recurrent dMMR endometrial carcinoma.
What problem it solves: after platinum and immunotherapy, only single-agent chemotherapies with short responses remain today; and in dMMR disease, the question is whether immunotherapy alone can replace first-line chemotherapy rather than be added to it.
Critical take: both are company-sponsored trials, TroFuse-005's benefit has so far been announced only by press release without figures, and we will need the effect size, toxicity (stomatitis, cytopenias) and real-world access in our setting.
https://www.merck.com/news/merck-showcases-first-time-pivotal-phase-3-results-from-oncology-pipeline-and-continued-innovative-potential-of-existing-portfolio-at-esmo-2026/
https://clinicaltrials.gov/study/NCT06132958
https://www.merck.com/news/merck-announces-trofuse-005-trial-evaluating-sacituzumab-tirumotecan-sac-tmt-met-primary-endpoints-of-overall-survival-os-and-progression-free-survival-pfs-in-certain-patients-with-advanced-or-r/
https://esmo.org/meeting-calendar/esmo-congress-2026

2. Senaparib (Sepalna) as first-line maintenance in ovarian cancer: European Commission decision

[Pending regulatory decision] [European Union] [Estimated date: late November 2026, per the usual ~67-day interval between a CHMP opinion and the European Commission decision]
What it is: the EMA's CHMP issued a positive opinion on September 17, 2026, for senaparib monotherapy as maintenance in adults with FIGO stage III–IV high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy. In the FLAMES trial (NCT04169997; 404 patients, 2:1 versus placebo), median PFS was not reached versus 13.6 months (HR 0.43; 95% CI, 0.32–0.58), with a similar HR with and without a BRCA mutation.
What problem it solves: it adds another PARP inhibitor option for first-line maintenance, currently done with olaparib (alone or with bevacizumab) or niraparib.
Critical take: the trial was run in China, overall survival is immature, serious adverse events were far more frequent than with placebo (27.8% vs 3.8%), and there is no head-to-head comparison with the PARP inhibitors already available.
https://www.ema.europa.eu/en/medicines/human/EPAR/sepalna
https://www.onclive.com/view/eu-approval-reccomended-by-chmp-for-senaparib-in-advanced-ovarian-cancer

3. Elinzanetant (Lynkuet) for hot flashes caused by breast cancer endocrine therapy: FDA decision

[Pending regulatory decision] [United States] [Estimated date: between late 2026 and early 2027, per the FDA's six-month priority review clock counted from receipt of the application; Bayer has not published the target action date]
What it is: the FDA accepted Bayer's supplemental application with priority review (announced September 28, 2026) for elinzanetant, a neurokinin-1 and -3 receptor antagonist, for moderate to severe vasomotor symptoms caused by endocrine therapy to treat or prevent HR+ breast cancer. It rests on OASIS-4: phase 3, 474 women aged 18 to 70, 2:1 randomization versus placebo, with a significant reduction in hot-flash frequency at weeks 4 and 12.
What problem it solves: these patients cannot take estrogen and are treated today with SSRIs/SNRIs, gabapentin or oxybutynin, with modest efficacy and side effects that limit adherence; the European Union, the United Kingdom, Switzerland and Canada have already approved this indication.
Critical take: the study was sponsored by Bayer and run outside the United States; long-term safety data in this population are lacking, and patients should be warned about sleepiness, one of the most frequent adverse events in the trial.
https://www.bayer.com/media/en-us/bayers-lynkuet-elinzanetant-granted-priority-review-by-us-fda-for-additional-indication/

4. March meetings: SGO 2027 and SMFM 2027

[Congress] [United States] [Confirmed date: March 19–22, 2027 (SGO, Phoenix) and March 21–26, 2027 (SMFM, National Harbor, Maryland)]
What it is: the Society of Gynecologic Oncology Annual Meeting and the Society for Maternal-Fetal Medicine Pregnancy Meeting, two forums where the year's gynecologic oncology and maternal-fetal medicine trials are usually first presented.
What problem it solves: they concentrate the spring's practice-changing results (screening, surgery, systemic therapy, prevention of preterm birth and preeclampsia).
Critical take: only the dates are confirmed so far; late-breaking abstracts have not been announced, so there is no specific result to expect yet.
https://www.sgo.org/events/annual-meeting/
https://www.smfm.org/events/2027-pregnancy-meeting

*What's next in obstetrics and gynecology — October 22, 2026*

1. ESMO 2026 (Madrid, Oct 23–27): sacituzumab tirumotecan after platinum and immunotherapy (TroFuse-005) and pembrolizumab alone vs chemo in dMMR endometrial cancer (KEYNOTE-C93), in the presidential symposium.
2. EU, decision estimated for late November: senaparib as first-line ovarian maintenance (positive CHMP opinion Sep 17).
3. FDA, decision estimated between late 2026 and early 2027: elinzanetant for hot flashes from breast cancer endocrine therapy (priority review).
4. March 2027: SGO (Phoenix, 19–22) and SMFM (National Harbor, 21–26); no late-breakers announced yet.

Each item with its official source and a critical take.

Full text and audio: https://boletinesmedicos.com/en/obgyn/2026-10-22-viene.html
MedBulletins · boletinesmedicos.com

What's next in obstetrics and gynecology (October 2026 – March 2027):

• ESMO 2026 (October 23–27): two phase 3 endometrial cancer trials in the presidential symposium, TroFuse-005 (sacituzumab tirumotecan after platinum and immunotherapy) and KEYNOTE-C93 (pembrolizumab alone vs chemotherapy in dMMR disease).
• European Union: decision estimated for late November on senaparib as first-line maintenance in ovarian cancer.
• FDA: priority review of elinzanetant for hot flashes induced by breast cancer endocrine therapy; decision estimated between late 2026 and early 2027.
• March 2027: SGO and SMFM, dates confirmed.

Each item carries its official source, how firm the date is, and a critical take.

Full text and audio: https://boletinesmedicos.com/en/obgyn/2026-10-22-viene.html

#Gynecology #Obstetrics #GynecologicOncology #Menopause #EvidenceBasedMedicine

What's next in OB/GYN: TroFuse-005 and KEYNOTE-C93 at ESMO (Oct 23–27), EU decision on senaparib (est. Nov), FDA on elinzanetant for endocrine-therapy hot flashes (est. late 2026–early 2027). https://boletinesmedicos.com/en/obgyn/2026-10-22-viene.html