Elinzanetant: A Novel Non-Hormonal Neurokinin 1 and 3 Receptor Antagonist Transforming Menopausal Vasomotor Symptom Management

Elinzanetant: A Novel Non-Hormonal Neurokinin 1 and 3 Receptor Antagonist Transforming Menopausal Vasomotor Symptom Management

Elinzanetant, approved in the UK in July 2025 and by the FDA in October 2025, is the first non-hormonal NK1 and NK3 receptor antagonist for moderate-to-severe menopausal vasomotor symptoms, demonstrated effective and safe in pivotal phase 2b/3 trials with added benefits on sleep and quality of life.
Elinzanetant for Menopausal Hot Flashes: A 52‑Week Phase 3 Trial Shows Modest, Durable Benefit and Acceptable Safety Profile

Elinzanetant for Menopausal Hot Flashes: A 52‑Week Phase 3 Trial Shows Modest, Durable Benefit and Acceptable Safety Profile

OASIS‑3 evaluated once‑daily oral elinzanetant 120 mg vs placebo for 52 weeks in postmenopausal women with moderate–severe vasomotor symptoms. At 12 weeks elinzanetant reduced daily moderate–severe VMS frequency by a least‑squares mean difference of −1.6 vs placebo (P < .001); numerical advantages persisted through 50–52 weeks with no signal for hepatotoxicity or endometrial hyperplasia.
ctDNA-Guided Adjuvant Therapy in Stage III Colon Cancer: DYNAMIC-III Validates Prognosis but Questions Intensification

ctDNA-Guided Adjuvant Therapy in Stage III Colon Cancer: DYNAMIC-III Validates Prognosis but Questions Intensification

The randomized phase 2/3 DYNAMIC-III trial shows that postoperative circulating tumor DNA (ctDNA) strongly stratifies recurrence risk in stage III colon cancer. ctDNA-guided de-escalation reduced oxaliplatin exposure and hospitalizations with outcomes close to standard care; escalation for ctDNA-positive disease did not improve recurrence-free survival.
Dual TIGIT/PD‑1 Blockade with Domvanalimab + Zimberelimab Plus FOLFOX Shows Promising Activity in First‑Line Advanced Gastric and GEJ Adenocarcinoma

Dual TIGIT/PD‑1 Blockade with Domvanalimab + Zimberelimab Plus FOLFOX Shows Promising Activity in First‑Line Advanced Gastric and GEJ Adenocarcinoma

A phase 2 arm of the EDGE‑Gastric trial reports a 59% confirmed objective response rate and median PFS 12.9 months with domvanalimab (anti‑TIGIT) plus zimberelimab (anti‑PD‑1) combined with FOLFOX in untreated HER2‑negative advanced gastric/GEJ/esophageal adenocarcinoma, with a manageable safety profile.
Dolutegravir + Lamivudine Is Non‑Inferior to Bictegravir/FTC/TAF for Maintenance Therapy at 48 Weeks: PASO‑DOBLE Randomised Trial

Dolutegravir + Lamivudine Is Non‑Inferior to Bictegravir/FTC/TAF for Maintenance Therapy at 48 Weeks: PASO‑DOBLE Randomised Trial

In PASO‑DOBLE, switching virologically suppressed adults to dolutegravir/lamivudine maintained viral suppression at 48 weeks and was non‑inferior to switching to bictegravir/emtricitabine/tenofovir alafenamide, supporting shared decision‑making for maintenance regimen selection.
Early Clinical Evaluation of Novel Broadly Neutralising Monoclonal Antibodies for HIV-1: Safety, Pharmacokinetics, and Neutralisation Profiles of N6LS, PGDM1400LS, and PGT121.414.LS

Early Clinical Evaluation of Novel Broadly Neutralising Monoclonal Antibodies for HIV-1: Safety, Pharmacokinetics, and Neutralisation Profiles of N6LS, PGDM1400LS, and PGT121.414.LS

This review summarizes early-phase clinical trials assessing the safety, pharmacokinetics, and neutralisation activity of three innovative broadly neutralising monoclonal antibodies—N6LS, PGDM1400LS, and PGT121.414.LS—for HIV-1 prevention and therapy.
Once‑Daily Dolutegravir/Lamivudine Fixed‑Dose Tablets Achieve Robust Pediatric Exposures and Reassuring Safety in the D3/PENTA 21 PK Sub‑Study

Once‑Daily Dolutegravir/Lamivudine Fixed‑Dose Tablets Achieve Robust Pediatric Exposures and Reassuring Safety in the D3/PENTA 21 PK Sub‑Study

A nested PK and safety sub‑study of D3/PENTA 21 shows once‑daily DTG/3TC dispersible and film‑coated fixed‑dose tablets deliver adequate drug exposures across WHO weight bands in children 2–<15 years, with no drug‑related discontinuations and comparable PK to historical pediatric data.