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About · curated by Nick Boehling, MD · @nb2276

    2026-11-04 ESMO Congress 2026

    digest generated 2026-11-05

    PE-PE: adding 1y perioperative pembrolizumab to SABR/surgery MDT in omRCC gave mRFS 25.4 vs 11.0mo, HR 0.47 (0.24-0.92), randomized phase II.
    TL;DR
    Organ preservation carried GI: AZUR-1 dostarlimab alone in dMMR/MSI-H LARC gave cCR12 68% (INV), single-arm interim; SANO surveillance after cCR to nCRT gave 5y OS 50% vs 54% but distant mets 46% vs 29%. PE-PE added pembrolizumab to MDT in omRCC (mRFS HR 0.47); PAM50 luminal-B predicted STADT benefit in RTOG 0534.

    Prostate

    Post-RP salvage RT biomarkers: Decipher prognostic in 9601, PAM50 luminal-B a candidate predictor of STADT benefit.

    Decipher and PAM50 in NRG/RTOG 9601 and 0534

    TL;DRASTRO 2026 secondary analyses: Decipher prognostic in 9601 but not formally predictive; PAM50 luminal-B predicted STADT benefit with salvage RT in 0534.

    Reported via UroToday →

    Trials discussed

    NRG/RTOG 9601NRG/RTOG 0534NRG-GU006NRG GU-009

    Why it mattersRadiation oncology

    The actionable split is early salvage with low Decipher: no significant 15-yr PCSM benefit from bicalutamide, while late salvage benefited regardless of score. PAM50 luminal-B status, reported on the Decipher grid, adds a predictive read for STADT. The PLNRT-by-subtype MFS trend is exploratory and should not yet move pelvic nodal coverage decisions.

    Monday clinic

    In a post-RP pt with early salvage PSA and Decipher ≤0.6, this questions the PCSM value of adding hormone therapy to salvage RT; it does not extend to late salvage pts, who benefited regardless of score. The longer read

    11 details
    Design

    Two ASTRO 2026 secondary biomarker analyses of randomized salvage trials, discussed in a UroToday interview. RTOG 9601: salvage RT ± bicalutamide 24 mo. RTOG 0534: PBRT vs PBRT + STADT vs PBRT + STADT + PLNRT, PAM50 on a subset.

    Population & inclusion

    Post-prostatectomy salvage pts. 9601 enrolled PSA 0.2 to 4.0, early and late salvage. The 0534 PAM50 subset showed no significant baseline differences across arms.

    Results

    Decipher was prognostic for OS, PCSM and DM, including early salvage, but not predictive by the statistical criterion. In 0534, luminal-B pts gained a large FFP benefit from STADT vs much less in non-luminal-B, with a significant interaction p.

    Salvage settingDecipherPCSM benefit at 15 yr
    Early salvage>0.6>5%
    Late salvageAny>5%
    Early salvageLow (≤0.6)No significant benefit
    vs leading data

    The PAM50 finding matches NRG-GU006, where luminal-B tumors benefited from apalutamide, so the signal holds across bicalutamide, leuprolide-based STADT and an ARPI. NRG GU-009/010 used a Decipher cut of 0.85 in the intact setting, vs 0.6 here post-op.

    Applies to
    post-prostatectomy pts receiving salvage prostate bed RT with a decision about adding hormone therapy
    Does not represent the intact-prostate definitive setting or the decision about pelvic nodal RT.
    Limitations

    No HRs, interaction p-values or absolute rates are given in the source interview. The PSA threshold separating early from late salvage is not stated. Decipher and PAM50 can be discordant, and the source offers no data on how to resolve that.

    Discussion

    Presenters frame both tests as one input to shared decision-making with pts, not a gate. Decipher reports PAM50 subtype on the same grid, so a single order yields both.

    Open questions
    • Does PAM50 luminal-B status predict benefit from pelvic nodal RT?
    • How to act on discordant Decipher and PAM50 results
    • Optimal Decipher cut point for de-intensifying ADT in early salvage
    📚 Sources · 📄 1 paper
    📄 PAPER · UroToday
    Genomic Biomarkers to Guide Hormone Therapy With Salvage Radiation: Decipher and PAM50 in NRG/RTOG 9601 and 0534 - Krishnan Patel & Shuang (George) Zhao
    article →
    Abstract
    UroToday - GU OncToday brings coverage of the clinically relevant content needed to stay at the forefront of the dynamic field of GU oncology and urology.
    📝 https://www.urotoday.com/video-lectures/genomic-classifier-in-prostate-cancer-post-radical-prostatectomy/video/5950-pam50-molecular-subtypes-in-prostate-cancer-trials-krishnan-patel-george-zhao.html?mtm_campaign=Patel_Zhao_SocialVideo_ID5950

    Combined Curative

    GI Lower

    dMMR/MSI-H LARC moving toward PD-1 blockade alone, with RT and surgery omitted in responders.

    Early signal

    AZUR-1 NCT05723562

    FordMMR/MSI-H locally advanced rectal cancer, treatment-naive

    TL;DRcCR12 68% (investigator) and cCR12+pCR 76% with dostarlimab alone in dMMR/MSI-H LARC, no recurrences to date at 26.3mo median f/u.

    Why it mattersRadiation oncology

    The RT-omission read hinges on the assessor: investigator cCR12 is 68%, central review 47% (54/116) with 38 pts still pending. Either figure exceeds the 21-41% post-TNT cCR range the source cites, which supports MMR testing before any pelvic RT is planned in LARC.

    Monday clinic

    In dMMR/MSI-H LARC, this supports checkpoint-first, organ-preservation discussion before committing to chemoRT or TNT; it does not extend to pMMR/MSS rectal cancer. The longer read

    10 details 2 trials watching
    Design

    Global single-arm phase II, registrational. Interim analysis, N=154 enrolled, median f/u 26.3 mo (range 2-36).

    Population & inclusion

    dMMR/MSI-H locally advanced rectal cancer. 144 pts had ≥12 mo f/u for investigator-assessed cCR12.

    Regimen

    Dostarlimab 500 mg IV q3w for 9 cycles as monotherapy; chemotherapy, radiation and surgery reserved for non-responders.

    Endpoints

    Key endpoints: sustained cCR for 12 months (cCR12) after end of treatment by investigator and independent central review, and composite cCR12 (INV) + pCR.

    Results

    cCR12 68% (INV) vs 47% (54/116) (ICR); composite cCR12+pCR 76%. Of 15 resected pts, 12 (80%) had pCR; no recurrences to date after cCR or pCR.

    AssessorEvaluablecCR12
    Investigator14468%
    Independent central review11654/116 (47%)
    Safety

    88% completed all 9 cycles. G≥3 immune-mediated AEs in 4 pts.

    vs leading data

    Post-TNT cCR is cited at 21-41% in LARC broadly; AZUR-1 exceeds that in a biomarker-selected group. It scales up the earlier small dostarlimab study that first showed durable cCR in dMMR LARC.

    Applies to
    dMMR/MSI-H locally advanced rectal cancer treated with PD-1 monotherapy first
    Does not represent pMMR/MSS rectal cancer, where TNT and chemoRT remain the backbone.
    Limitations

    Investigator and central review diverge on cCR12, and ICR evaluability lagged because cCR was confirmed later. cCR12 is a surrogate for durable organ preservation; local regrowth risk beyond 3 years is unmeasured.

    Discussion

    Durable cCR with no recurrences so far makes RT omission a realistic default question in dMMR LARC. Open: how long surveillance must run, and what salvage looks like for late regrowth.

    Rationale

    Single-arm interim analysis without a randomised comparator; investigator vs central review cCR12 diverge, and durability beyond 26.3mo median f/u is unproven.

    Open questions

    Sourced from Andrea Cercek

    📚 Sources · 📄 2 papers
    📄 PAPER Andrea Cercek · ESMO Congress 2026 (2026-10)
    Clinical complete response with dostarlimab monotherapy in dMMR/MSI-H locally advanced rectal cancer (LARC): First results from the global registrational AZUR-1 trial
    article →
    Abstract
    ESMO Congress 2026 abstract LBA87 · Proffered paper: Gastrointestinal tumours, lower digestive · 2026-10-25 · presented by Andrea Cercek (New York, United States of America, NY) · NCT05723562<br/><br/>Background: Multimodal treatment with chemotherapy, radiation and surgery is a standard of care (SOC) for LARC associated with significant toxicity/morbidity. After TNT, the range of clinical complete response (cCR) is 21–41%. dMMR/MSI-H tumours are exceptionally responsive to PD-1 blockade: in a small study, neoadjuvant dostarlimab treatment led to durable cCRs and eliminated the need for SOC in most patients (pts) with LARC. AZUR-1 (NCT05723562) is a global single-arm trial and the first registrational study evaluating the clinical benefit of dostarlimab monotherapy in pts with dMMR/MSI-H LARC.<br/>Methods: Dostarlimab 500 mg was administered IV every 3 weeks for 9 cycles. Key endpoints include rate of sustained cCR for 12 months (cCR12) following end of treatment (EOT) with dostarlimab alone by investigator (INV) and independent central review (ICR), and composite rate of cCR12 (INV) + pathological CR (pCR).<br/>Results: At data cutoff (DCO, 20 April 2026), 154 pts were enrolled and median follow-up was 26.3 months (range 2–36). Of 144 pts with ≥12 months follow-up, 68% achieved cCR12 (INV). Of 15 pts who underwent surgery after dostarlimab alone, 12 (80%) had pCR, resulting in a cCR12+pCR rate of 76%. Fewer pts were cCR12-evaluable by ICR, primarily due to cCR being confirmed later by ICR after initial EOT evaluation. Of pts evaluable by ICR, 47% (54/116) achieved cCR12, with 38 pts in cCR and being followed for cCR12 at DCO. 98% of pts who achieved cCR remained in cCR for ≥12 months by INV or ICR, with no recurrences to date for pts who achieved cCR or pCR. Overall, 93% of patients are in surveillance with no evidence of disease progression after treatment (dostarlimab ± SOC) and 71% achieved this outcome with dostarlimab alone. The safety profile was acceptable: 88% of pts completed all 9 cycles of dostarlimab and Grade ≥3 immune-mediated AEs occurred in 4 pts.<br/>Conclusions: In this AZUR-1 interim analysis, 68% of pts achieved cCR12 and 76% achieved cCR12+pCR with dostarlimab alone with no disease recurrences to date. These durable responses indicate the potential to eliminate the need for chemotherapy, radiation and surgery, and redefine the curative-intent treatment paradigm for pts with dMMR/MSI-H LARC.<br/>Clinical trial identification: NCT05723562.
    📄 PAPER · Oncodaily - Oncology News, Insights, Stories (2026-10)
    AZUR-1 at ESMO 2026: Dostarlimab monotherapy in dMMR/MSI-H Locally Advanced Rectal Cancer - OncoDaily
    article →
    Abstract
    AZUR-1 at ESMO 2026: Dostarlimab monotherapy in dMMR/MSI-H Locally Advanced Rectal Cancer / AZUR-1 trial, cancer, cancer care, Cancer research, cancer

    Systemic Curative Phase 2 trial Early signal ESMO Congress 2026

    GI Upper

    Surveillance after cCR to nCRT spares oesophagectomy at the cost of a distant mets excess.

    Confirmatory

    SANO

    ForLocally advanced oesophageal cancer, cCR after nCRT

    TL;DR5y OS 50% vs 54%, HR 1.17 (0.77-1.77) active surveillance vs surgery after cCR to nCRT; distant mets 46% vs 29%, P<.01.

    Why it mattersRadiation oncology

    The RT read is that nCRT alone was the definitive treatment for 43% of the surveillance arm, but distant mets rose to 46% vs 29% without immediate surgery. That makes cCR after nCRT a reasonable organ-preservation endpoint for selected pts. Whether early oesophagectomy suppresses distant spread, or the gap comes from how surveillance detects disease, is the open question.

    Monday clinic

    In locally advanced oesophageal cancer with cCR on biopsies, EUS and PET-CT after nCRT, this supports active surveillance with surgery as needed as a discussable option; it does not address pts without cCR or nCRT regimens other than those used in SANO. The longer read

    9 details 1 trial watching
    Design

    Multicentre stepped-wedge cluster-randomised non-inferiority trial, 2017-2021, Netherlands Trial Register NTR-6803. This report covers 5y outcomes at median f/u 76 mo (IQR 67-86).

    Population & inclusion

    Locally advanced oesophageal cancer with a complete clinical response after nCRT, defined as no tumour on endoscopic biopsies, endoscopic ultrasound, or PET-CT. N=309: 198 active surveillance, 111 standard surgery.

    Radiotherapy

    nCRT was the common backbone. The regimen, dose and fractionation are not stated in source, so whether the result transfers to a given chemoRT protocol cannot be judged from this abstract.

    Endpoints

    The earlier report showed non-inferiority on two-year OS with improved QoL under surveillance. This analysis compares 5y OS and DFS by Cox regression and estimates distant metastasis incidence with competing-risk analysis.

    Results

    OS and DFS were not significantly different, but distant mets were higher under surveillance (P<.01). 85/198 (43%) were spared non-beneficial oesophagectomy.

    EndpointActive surveillance (n=198)Standard surgery (n=111)Effect
    5y OS50% (95%CI 34-57)54% (95%CI 46-64)HR 1.17 (95%CI 0.77-1.77)
    DFSnot reported per armnot reported per armHR 1.39 (95% CI 0.94-2.06)
    5y cumulative incidence distant mets46% (95%CI 39-53)29% (95%CI 21-37)P<.01
    vs leading data

    This extends SANO's own 2y non-inferiority result and follows the preSANO cCR-assessment framework. It parallels the watch-and-wait paradigm in rectal cancer (OPRA). The randomised definitive-CRT question is being tested separately in NEEDS.

    Applies to
    locally advanced oesophageal cancer with cCR on biopsies, EUS and PET-CT after nCRT
    Does not represent pts with residual disease after nCRT or those not fit for salvage oesophagectomy.
    Limitations

    The 43% spared figure counts pts with distant mets within 6 mo of nCRT, which inflates the organ-preservation benefit. At 5y, no NI margin is reported, and an OS HR upper bound of 1.77 cannot exclude clinically relevant harm.

    Discussion

    Survival parity holds at 5y, but the distant-mets excess is the signal to explain. It could reflect micrometastatic seeding during delayed resection, or disease surfacing on surveillance imaging that resection would have found later. The abstract cannot separate the two.

    Rationale

    Long-term f/u of a cluster-randomised NI trial supporting emerging organ preservation; wide OS CI and a significant distant-mets excess stop short of practice-changing.

    Open questions

    Sourced from Sanjiv S. Gangaram-Panday

    📚 Sources · 📄 2 papers
    📄 PAPER Sanjiv S. Gangaram-Panday · ESMO Congress 2026 (2026-10)
    Active surveillance versus standard surgery after neoadjuvant chemoradiotherapy for oesophageal cancer: Long-term results of a cluster-randomised controlled trial (SANO)
    article →
    Abstract
    ESMO Congress 2026 abstract LBA78 · Proffered paper 1: Gastrointestinal tumour, upper digestive · 2026-10-23 · presented by Sanjiv S. Gangaram-Panday (Rotterdam, Netherlands)<br/><br/>Background: The Surgery As Needed for Oesophageal cancer (SANO)-trial demonstrated that active surveillance is non-inferior to standard surgery in terms of two-year overall survival in patients with a complete clinical response after neoadjuvant chemoradiotherapy (nCRT). Active surveillance resulted in improved quality of life. Here, we report 5-year outcomes.<br/>Methods: From 2017 to 2021, a multicentre stepped-wedge cluster-randomised non-inferiority trial was conducted. Patients with locally advanced oesophageal cancer who achieved complete clinical response (defined as no tumour detected on endoscopic biopsies, -ultrasound, or PET-CT) underwent active surveillance or standard surgery. Cox regression was used to compare 5-year overall and disease-free survival, and the cumulative incidence of distant metastases was estimated using competing risk analysis.<br/>Results: A total of 309 patients were included, 198 underwent active surveillance and 111 underwent standard surgery. Median follow-up was 76 months (IQR 67–86). Five-year overall survival was not statistically significantly different between active surveillance and standard surgery (50%, 95%CI 34-57 vs. 54%, 95%CI 46-64; HR 1.17, 95%CI 0.77-1.77) with similar results across histologic subtypes. Disease-free survival was not statistically significantly different (HR 1.39, 95% CI 0.94-2.06). The cumulative incidence of distant metastases at five years was significantly higher in the active surveillance group compared to the standard surgery group (46%, 95%CI 39-53 vs. 29%, 95%CI 21-37; P<.01). Overall, 85 of 198 patients (43%) were spared non-beneficial oesophagectomy, including those with sustained complete clinical response at last follow-up or distant metastases detected within six months after nCRT.<br/>Conclusions: Overall survival at 5 years is not statistically significantly different between active surveillance and standard surgery in patients with oesophageal cancer and a complete clinical response after nCRT, despite a higher incidence of distant metastases in the active surveillance group. These findings support active surveillance as a feasible treatment strategy in these patients.<br/>Clinical trial identification: The Netherlands Trial Register (NTR-6803).
    📄 PAPER · Oncodaily - Oncology News, Insights, Stories (2026-10)
    Can Surgery Be Avoided After Chemoradiotherapy for Esophageal Cancer? Long-Term SANO Trial Results - OncoDaily
    article →
    Abstract
    Can Surgery Be Avoided After Chemoradiotherapy for Esophageal Cancer? Long-Term SANO Trial Results / chemoradiotherapy, esmo 2026, ESMO 26, esophageal cancer,

    Surgery Curative Confirmatory ESMO Congress 2026

    Kidney

    Randomized phase II signal that IO adds RFS to SABR-dominant MDT in oligometastatic RCC.

    Early signal

    PE-PE NCT05578664

    ForOligometastatic RCC, ≤3 mets within 5y of prior nephrectomy, MDT-eligible

    Relapse-free survival surrogate

    HR 0.47

    95% CI 0.24-0.92, p=0.024; mRFS 25.4 vs 11.0 mo

    TL;DRmRFS 25.4 vs 11.0 mo, HR 0.47 (0.24-0.92), p=0.024, adding 1y perioperative pembrolizumab to SABR/surgery MDT in omRCC.

    Why it mattersRadiation oncology

    SABR was the MDT in 73% vs 72% of pts, so this is mostly pembrolizumab plus SABR vs SABR alone. Dose/fractionation and the local relapse secondary aren't in the abstract, so it can't yet show whether P changes in-field control or only cuts distant events. The decision it moves is whether SABR to all sites goes ahead with or without IO.

    Monday clinic

    In post-nephrectomy omRCC with ≤3 mets within 5y planned for SABR or metastasectomy, this supports discussing 1y of perioperative pembrolizumab with MDT; it does not extend to >3 mets or relapse beyond 5y of nephrectomy. The longer read

    10 details
    Design

    Randomized 2:1, open-label, multicenter phase II, N=85 (56 P+MDT, 29 MDT alone). Median follow-up 17.5 mo.

    Population & inclusion

    omRCC after prior nephrectomy, ≤3 metastases within 5 years of Nx or prior metastasectomy, candidates for MDT to all metastatic sites. Baseline characteristics reported as balanced.

    Regimen

    Pembrolizumab 400 mg q6w × 9 cycles (1 year), first dose before MDT. Median cycles delivered 6.6.

    Radiotherapy

    MDT was SABR in 73% vs 72% and surgery in 23% vs 28%. Dose, fractionation and target definition not reported in source.

    Endpoints

    Primary: relapse-free survival. Secondary: distant RFS, local relapse, OS, safety; only safety secondaries are reported in the abstract.

    Safety

    Any AE 80% vs 21%, G3 7% vs 3%. P-related AEs 59%, led by hypothyroidism 23%; no G4/5.

    vs leading data

    KEYNOTE-564 established adjuvant pembrolizumab after Nx and for M1NED within 1 year of Nx. PE-PE moves that into unresected oligomets ablated by SABR or surgery, including relapse up to 5 years out.

    Applies to
    post-nephrectomy omRCC with ≤3 metastases within 5 years, all sites treatable by SABR or surgery
    Does not represent pts with >3 metastases, no prior nephrectomy, or relapse beyond 5 years.
    Limitations

    No local vs distant relapse split, so the site of benefit is unknown. RFS assessor blinding not stated in an open-label trial, and 2 of the 9 planned cycles went undelivered at the median.

    Discussion

    The RFS gain is large but rests on 35 events, with a CI upper bound of 0.92. It does not settle whether IO at MDT beats IO deferred to relapse, which is the comparison that decides treatment-free intervals.

    Results
    EndpointP+MDT (n=56)MDT alone (n=29)Effect
    Median RFS25.4 mo11.0 moHR 0.47 (95% CI 0.24-0.92), p=0.024
    RFS events191635 total
    Any AE80%21%n/a
    G3 AE7%3%n/a
    Enrolment
    CONSORT flow
    Randomized85
    ↓
    P+MDT
    allocated 56
    mRFS 25.4 mo
    MDT alone
    allocated 29
    mRFS 11.0 mo
    Rationale

    Randomized phase II met its RFS primary, but N=85 with a 29-pt control arm, 17.5-mo median f/u, open-label, and only 2 deaths; abstract-only.

    Open questions
    • Local vs distant relapse split: where does pembrolizumab add benefit?
    • OS benefit vs deferring IO until relapse after MDT
    • SABR dose/fractionation interaction with perioperative IO

    Sourced from Roberto Iacovelli

    📚 Sources · 📄 1 paper
    📄 PAPER Roberto Iacovelli · ESMO Congress 2026 (2026-10)
    PErioperative PEmbrolizumab (P) plus metastasis-directed therapy (MDT) versus MDT alone in patients (pts) with oligometastatic renal cell carcinoma (omRCC): The randomized phase II PE-PE trial
    article →
    Abstract
    ESMO Congress 2026 abstract LBA88 · Proffered paper 2: Genitourinary tumours, renal and urothelial · 2026-10-25 · presented by Roberto Iacovelli (Rome, Italy) · NCT05578664<br/><br/>Background: Adjuvant P is the standard of care for pts with intermediate-high/high risk of relapse after nephrectomy (Nx), as well as for those with M1NED within 1y of previous Nx. Although omRCC pts may receive anti-PD-1-based combos, the optimal management of those eligible for MDT remains uncertain.<br/>Methods: The PE-PE trial (NCT05578664) is a randomized, open-label, multicenter phase II study evaluating the efficacy of P in delaying tumor progression for omRCC pts candidates for MDT, including surgery or SABR to all metastatic sites. Eligible pts had undergone prior Nx and presented with ≤3 metastases within 5 years of Nx or previous metastasectomy. Pts were randomized 2:1 to receive P 400 mg every 6 weeks for 9 cycles (1 year) plus MDT (P+MDT) or MDT alone. The first dose of P was administered before MDT. The primary endpoint was relapse-free survival (RFS), while others included distant RFS, local relapse, OS, and safety.<br/>Results: 85 pts were randomized between March 2023 and February 2026: 56 to the P+MDT arm and 29 to the MDT-alone arm. Baseline characteristics were well balanced between treatment groups. SABR was selected in 73% vs. 72% of pts, while surgery was performed in 23% vs. 28%, respectively. The median number of P cycles administered was 6.6. The most frequent reasons for P discontinuation were disease progression (11 pts) and adverse events (AE, 4 pts). After a median follow-up of 17.5 mos, 35 RFS events were observed (19 vs.16), with two deaths (one in each arm). Median RFS was 25.4 mos in the P+MDT arm vs. 11.0 mos in the MDT-alone arm (HR 0.47; 95% CI, 0.24-0.92; p=0.024). Regarding safety, 80% vs. 21% of pts experienced at least one AE, while G3 AEs occurred in 7% vs. 3% of pts in the P+MDT and MDT-alone arms, respectively. P-related AEs of any G occurred in 59%, the most common being hypothyroidism (23%), fatigue (18%), and diarrhea (16%). Two pts experienced G3 toxicity without G4 or 5.<br/>Conclusions: The PE-PE trial supports the use of 1 year of perioperative P in pts with omRCC eligible for MDT, demonstrating a statistically significant and clinically meaningful improvement in RFS with a manageable and consistent safety profile.<br/>Clinical trial identification: NCT05578664.

    Combined Phase 2 trial Early signal ESMO Congress 2026