Watch-and-wait (W&W) strategy for dostarlimab in localized deficient dMMR/MSI-H gastroesophageal adenocarcinoma (GEA): Results from the first interim analysis of the GERCOR-GONO DEWI phase II study
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ESMO Congress 2026
October 23–27, 2026 · Madrid · 2677 items
dostarlimab
20 people · 20 posts · 1 abstract
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Dostarlimab is a PD-1-targeting monoclonal antibody, one of the ten approved anti-PD-1 antibodies worldwide[2], and it received marketing approval in the United States or European Union in 2021[6]. The pivotal published phase 3 evidence for this asset comes from a randomized, double-blind, placebo-controlled trial in primary advanced or recurrent endometrial cancer: among 494 randomized patients, 23.9% (118) had dMMR/MSI-H tumors, with progression-free survival among the primary endpoints in this population[3]; earlier, in a phase 1 single-arm study, single-agent dostarlimab (500 mg every 3 weeks for 4 doses, then 1000 mg every 6 weeks) was evaluated for clinical activity and safety in recurrent or advanced dMMR endometrial cancer[5]. The precedent most directly relevant to this readout is the phase 2 study in dMMR locally advanced rectal cancer: single-agent dostarlimab every 3 weeks for 6 months, with patients achieving clinical complete response (cCR) proceeding without chemoradiotherapy and surgery, and sustained cCR at 12 months after completion among the primary endpoints[1].
What is being presented at ESMO26 is the first interim analysis of the GERCOR-GONO DEWI phase II study, presented by Thierry André: patients with localized dMMR/MSI-H gastroesophageal adenocarcinoma (GEA) received dostarlimab, and those achieving cCR entered watch-and-wait, with the primary endpoint being 1-year cCR without surgery. Per the OncoAlert abstract, among 24 evaluable patients the 1-year cCR was 62.5% (15/24); at a median follow-up of 16.20 months, no relapse or death occurred among those with 1-year cCR; grade 3-4 dostarlimab-related AEs were 21% (5/24); 9/24 underwent surgery, all with R0 resection. It should be noted that the numbers across the on-site posts are inconsistent: other posts report on 43 patients, with 1-year cCR with organ preservation of 67.4% (29/43), no relapse or death among these 29 W&W patients, surgery in 14/43 (32.5%), and follow-up of 14.9 months; yet another post cites 25 pts enrolled, 33% cCR at 1 year, 1 pt with PD, and that the study continues. The exact figures await confirmation from the formal presentation.
Placing this readout against existing knowledge, the step forward lies in extending the path of deferring surgery after immunotherapy-induced cCR from dMMR localized rectal cancer[1] to another dMMR/MSI-H solid tumor site - gastroesophageal adenocarcinoma - as one on-site comment put it, 'after rectal, this is the next frontier.' The underlying rationale builds on the sensitivity of dMMR/MSI-H tumors to PD-1 blockade, supported in both endometrial cancer and rectal cancer[1][3][5]. The on-site discussion suggested its significance goes beyond efficacy numbers, toward a potential shift in treatment philosophy: from 'treat, then operate' to 'treat, assess deeply, and preserve the organ when oncologically safe'; the challenges are how confidently true complete responders can be identified and how durable the response remains over time.
The limitations are equally clear: small sample size (24 evaluable patients; 43 by the full-cohort reading), short follow-up (median 14.9-16.2 months), a single-arm phase II interim analysis, and the inconsistencies across posts themselves suggest the data are still evolving; roughly one-third of patients still underwent surgery (9/24 or 14/43), surgery omission remains an investigational strategy, and longer follow-up is needed to verify the durability of responses.
- 1.PD-1 Blockade in Mismatch Repair-Deficient, Locally Advanced Rectal Cancer · N Engl J Med 2022
- 2.Combination strategies with PD-1/PD-L1 blockade: current advances and future directions · Mol Cancer 2022
- 3.Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer · N Engl J Med 2023
- 4.Antibodies to watch in 2020 · MAbs 2020
- 5.Clinical Activity and Safety of the Anti-Programmed Death 1 Monoclonal Antibody Dostarlimab for Patients With Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer: A Nonrandomized Phase 1 Clinical Trial · JAMA Oncol 2020
- 6.Antibodies to watch in 2022 · MAbs 2022
OncoAlert@OncoAlert OncoAlert 4Sight Abstracts to be Presented at #ESMO26
Arndt Vogel@ArndtVogel Vilma P. Barcia MD, PhD, MSc@DrVilmaPBarcia Dra. María Natalia Gandur Quiroga@nataliagandur 🧬 When immunotherapy produces a complete response, should surgery still be automatic?
引用@OncoAlert 4Sight Abstracts to be Presented at #ESMO26 Watch-and-Wait Strategy for Dostarlimab in Localized dMMR/MSI-H Gastroesophageal Adenocarcinoma: Results From the First Interim Analysis of the GERCOR-GONO DEWI Phase II Study 🔬 Phase II, first interim analysis (24 evaluable patients): dostarlimab with a watch-and-wait strategy in localized dMMR/MSI-H gastroesophageal adenocarcinoma. Primary endpoint: 1-year cCR without surgery. ➡️ 1-year cCR: 62.5% (15/24) ➡️ No relapse or death in patients with 1-year cCR (median follow-up 16.20 mo) ➡️ Grade 3–4 dostarlimab-related AEs: 21%; 9/24 underwent surgery, all R0 ✅ dostarlimab led to a 62.5% 1-year cCR at the first interim analysis, enabling organ preservation. 🎙️ Thierry André 👥 Christelle de la Fouchardière (4Sight Made from Abstracts publicly available at the ESMO website) @CathyEngMD, @BenWestphalen, @graokane, @NiuSanford, , @GillSharlene, @pashtoonkasi, @DrVilmaPBarcia, @Erman_Akkus, @GIMedOnc, @UOzkerim, @MarioBalsaMD, @p_ciracimd, @DraMartinezLago, @DaisukeKotani, @Aiims1742, @ARosen380, @realbowtiedoc, @KoheiShitara,
Same topic dostarlimab · 20 people#GICANCER#MSIHIGH#DMMR#ORGANPRESERVATION178 views6 likes2 reposts0 repliesGil Morgan, MD@weoncologists Organ preservation in gastroesophageal cancer is no longer hypothetical 👀
引用@OncoAlert 4Sight Abstracts to be Presented at #ESMO26 Watch-and-Wait Strategy for Dostarlimab in Localized dMMR/MSI-H Gastroesophageal Adenocarcinoma: Results From the First Interim Analysis of the GERCOR-GONO DEWI Phase II Study 🔬 Phase II, first interim analysis (24 evaluable patients): dostarlimab with a watch-and-wait strategy in localized dMMR/MSI-H gastroesophageal adenocarcinoma. Primary endpoint: 1-year cCR without surgery. ➡️ 1-year cCR: 62.5% (15/24) ➡️ No relapse or death in patients with 1-year cCR (median follow-up 16.20 mo) ➡️ Grade 3–4 dostarlimab-related AEs: 21%; 9/24 underwent surgery, all R0 ✅ dostarlimab led to a 62.5% 1-year cCR at the first interim analysis, enabling organ preservation. 🎙️ Thierry André 👥 Christelle de la Fouchardière (4Sight Made from Abstracts publicly available at the ESMO website) @CathyEngMD, @BenWestphalen, @graokane, @NiuSanford, , @GillSharlene, @pashtoonkasi, @DrVilmaPBarcia, @Erman_Akkus, @GIMedOnc, @UOzkerim, @MarioBalsaMD, @p_ciracimd, @DraMartinezLago, @DaisukeKotani, @Aiims1742, @ARosen380, @realbowtiedoc, @KoheiShitara,
Nieves Martinez Lago MD PhD@DraMartinezLago Memorial Sloan Kettering Cancer Center@MSKCancerCenter ESMO - Eur. Oncology@myESMO OsmanKostekMD@OncologyMarwarD Evelyn Wong@EvelynWongYT Organ preservation beyond the rectum? 👀
ScienceLink@sciencelinkonco #ScienceLink #Madrid2026 #ESMO26 #DEWI #Dostarlimab
Same topic dostarlimab · 20 people#SCIENCELINK#MADRID2026#DEWI#DOSTARLIMAB46 views0 likes0 reposts0 repliesmp.weixin.qq.com FDA Grants Accelerated Approval to GSK's Dostarlimab for Stage II-III MSI-H/dMMR Locally Advanced Rectal Cancer
The FDA has granted accelerated approval to GSK's PD-1 inhibitor dostarlimab (Jemperli) as monotherapy for adult patients with stage II or III MSI-H/dMMR locally advanced rectal cancer. In China, the drug is in phase III trials for colon cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer, and is not yet approved.
Same topic dostarlimab · 20 peopleNo engagement yetmp.weixin.qq.com GSK dostarlimab wins FDA accelerated approval for MSI-H/dMMR locally advanced rectal cancer
GSK announced on October 19 that dostarlimab has received FDA accelerated approval for adults with stage II and III MSI-H/dMMR locally advanced rectal cancer. The approval is based on single-arm results from the phase 2 AZUR-1 study, in which most patients achieved a sustained complete clinical response.
Same topic dostarlimab · 20 peopleNo engagement yetmp.weixin.qq.com GSK Anti-PD-1 Antibody Dostarlimab Wins FDA Accelerated Approval for Locally Advanced MSI-H/dMMR Rectal Cancer
GSK announced that the FDA has granted accelerated approval to its anti-PD-1 antibody dostarlimab for adults with stage II and III MSI-H/dMMR locally advanced rectal cancer. The company described it as the first immunotherapy approved in the United States for this population. The approval is based on data from the phase 2 AZUR-1 trial. Dostarlimab generated global sales of $1.136 billion in 2025.
Same topic dostarlimab · 20 peopleNo engagement yetmp.weixin.qq.com FDA Grants Accelerated Approval to Dostarlimab for Organ Preservation in Untreated Stage II/III MSI-H/dMMR Locally Advanced Rectal Cancer
The FDA has granted accelerated approval to dostarlimab for previously untreated stage II/III MSI-H/dMMR locally advanced rectal cancer. Of 154 patients, 110 no longer required surgery, radiotherapy, or chemotherapy. The approval gives some patients who would otherwise need a permanent stoma an option to avoid surgery, radiotherapy, and chemotherapy.
Same topic dostarlimab · 20 peopleNo engagement yetFDA DrugsPick FDA grants accelerated approval to dostarlimab for locally advanced rectal cancer
On October 19, 2026, the FDA granted accelerated approval to dostarlimab (Jemperli, GSK) for adults with previously untreated, MSI-H or dMMR Stage II/III locally advanced rectal cancer, based on single-arm trial data.
Why it matters: The article gives specific values and confidence intervals for cCR12 and ORR, letting readers compare neoadjuvant immunotherapy regimens for dMMR rectal cancer.
Same topic dostarlimab · 20 peopleNo engagement yetbiocentury.com GSK’s Jemperli gains rectal cancer approval as rivals advance across colorectal settings
FDA granted accelerated approval to GSK's Jemperli (dostarlimab) for dMMR/MSI-H locally advanced rectal cancer, based on interim results from the Phase II AZUR-1 trial in which nearly three-fourths of patients avoided surgery at a median follow-up of two years. The approval gives Jemperli an indication outside Keytruda's label, and ESMO will present data on other checkpoint inhibitors across lines of colorectal cancer therapy.
Same topic dostarlimab · 20 peopleNo engagement yetmedicalxpress.comPick New drug could let some rectal cancer patients skip chemotherapy, radiation and surgery
The FDA granted accelerated approval to dostarlimab-gxly (Jemperli) for previously untreated stage 2/3 dMMR rectal cancer, based on a 154-patient trial in which about 75% of patients avoided surgery, radiation and chemotherapy within two years of follow-up. An earlier MSKCC study of 50 patients found no evidence of cancer in any of them, and of 27 followed for three years only one relapsed. Patient Jessica Acosta, 29, with a 6 cm tumor, achieved no evidence of disease after treatment. GSK must continue tracking long-term benefit.
Why it matters: FDA accelerated approval of dostarlimab for dMMR rectal cancer spares about three quarters of patients surgery, radiation and chemotherapy within two years, offering a new organ-preservation option.
Same topic dostarlimab · 20 peopleNo engagement yetFDA Drugs FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery
On October 19, the FDA granted accelerated approval to Jemperli (dostarlimab-gxly) as a single agent for adults with previously untreated dMMR or MSI-H stage II or III locally advanced rectal cancer.
Same topic dostarlimab · 20 peopleNo engagement yet