Shots:
Merck has reported the P-III (KEYNOTE‑C93) trial assessing Keytruda (400mg, IV, Q6W for ~18 cycles) vs carboplatin + paclitaxel in pts (n=299) with dMMR advanced or recurrent endometrial cancer who have not previously been treated with systemic CT
Trial met its 1EP of improved PFS, & showed improvements across ORR, CRR, & DoR; OS (1EP)…
Shots:
Merck has reported global P-III (TroFuse-005) trial data assessing sac-TMT (4 mg/kg, Q2W) vs doxorubicin/paclitaxel in 776 pts with endometrial carcinoma & carcinosarcoma who have received prior Pt-based CT & anti-PD-1/anti-PD-L1 immunotherapy either together or separately
Trial met its 1EP of improved OS & PFS in the above pts, plus it also reached its key…
Shots:
Sensei Biotherapeutics has dosed the first patient in P-Ib/II (FTH-PIK-101) trial assessing PIKTOR (serabelisib & sapanisertib) + fulvestrant &/or other anticancer therapies in pts with HR+/HER2- advanced or metastatic breast cancer
PIKTOR was evaluated in the P-Ib study in heavily pretreated advanced breast, endometrial, & ovarian cancers, where PIKTOR + paclitaxel achieved a 47%…
Shots:
Utepreva has launched the Utepreva Endometrial Sampler, a single-use device designed to improve tissue capture & enable early diagnostic evaluation of endometrial cancer, with availability expected in Oct 2026
The device combines three mechanisms for single-pass sampling: a sponge tip absorbs tissue & fluid, a plunger-driven suction aspirates cells & prevents loss, & the…
Shots:
BioNTech reported positive results from a P-II study cohort of trastuzumab pamirtecan (BNT323/DB-1303) in HER2-expressing recurrent endometrial cancer, meeting its 1EP of ORR
The study cohort (n=145) demonstrated a confirmed ORR of 47.9% (n=96; central testing) and 49.3% in pts. (n=73) previously treated with checkpoint inhibitors, with a mPFS of 8.1mos., showing consistent efficacy…
Shots:
Daiichi Sankyo has dosed the first patient with Enhertu ± radiotherapy in the P-III (DESTINY-Endometrial02) trial, conducted in collaboration with The GOG Foundation & ENGOT, with the GINECO as the lead ENGOT group
The trial will evaluate the efficacy and safety of Enhertu (5.4mg/kg) ± radiotherapy vs SoC CT (carboplatin & paclitaxel) ± radiotherapy…
Shots:
FDA approved Inluriyo (200mg; PO) for treating adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after ≥1L of endocrine therapy; US availability expected in the coming wks.
Approval was based on P-III (EMBER-3) trial (N=874: 32% in 1L & 64% in 2L treatment post progression) assessing Inluriyo ± abemaciclib vs fulvestrant/exemestane…
Shots :
Daiichi reported the first patient dosing in a P-III (DESTINY-Endometrial01) study evaluating ENHERTU (trastuzumab deruxtecan) + rilvegostomig or pembrolizumab vs Pt. chemotx. (carboplatin and paclitaxel) + pembrolizumab as 1L therapy, in HER2-expressing (IHC 3+/2+), pMMR advanced or recurrent endometrial cancer pts
The study is assessing the efficacy and safety of ENHERTU (5.4 mg/kg)…
Shots:
The EC has approved Jemperli + CT (carboplatin & paclitaxel) as a 1L treatment of primary advanced or recurrent endometrial cancer in adults eligible for systemic therapy
Approval was based on part 1 of P-III (RUBY) study assessing Jemperli + CT followed by Jemperli vs CT + PBO followed by PBO and part…
Shots:
The EMA approved 3 BLA while 4 New Chemical Entities in December 2023, leading to treatments for patients and advances in the healthcare industry
In December 2023, the major highlighted drugs were Jempreli to treat dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer and Zilbrysq for the treatment of Generalized Myasthenia Gravis
PharmaShots has compiled a list of a…

