Adjuvant Aspirin for Stage III Colorectal Cancer After Curative Resection: Primary Analysis of The Randomized Double-Blind Placebo-Controlled Phase III Trial (EPISODE-III: JCOG1503C)

• Adjuvant chemotherapy is the current standard treatment for stage III colorectal cancer after curative resection. However, the prognosis of stage III colorectal cancer is still poor even after curative resection and adjuvant chemotherapy.
•  Several observational studies suggested that the anti-tumor effect of aspirin. Therefore, they have planned a randomized double-blind placebo-controlled phase III trial, which commenced in Japan in March 2018, to confirm the superiority of aspirin over placebo added to adjuvant chemotherapy in terms of disease-free survival (DFS) for stage III colorectal cancer patients after curative resection. 
• A total of 880 patients will be accrued from 20 Japanese institutions within 3 years. The primary endpoint is DFS and the secondary endpoints are overall survival, relapse-free survival, relative dose intensity, adverse events, and serious adverse events. 

Reference: LBA3508 – ASCO 2026

BREAKWATER: Progression-Free and Overall Survival Analyses of First-Line (1L) Encorafenib + Cetuximab (EC) + FOLFIRI in BRAF V600E-mutant Metastatic Colorectal Cancer (mCRC)

• In Cohort 3, 147 pts were randomized. Baseline demographics and disease characteristics were similar between arms. At data cutoff, EC+FOLFIRI demonstrated a clinically meaningful and statistically significant improvement in confirmed ORR by BICR vs control, meeting the primary EP. 
• Responses observed with EC+FOLFIRI were rapid and durable. OS data were immature but suggested a potential survival benefit with EC+FOLFIRI vs control. The safety profile was consistent with that known for each agent. The addition of EC to FOLFIRI did not lead to substantial increases in FOLFIRI discontinuation. 
•  BREAKWATER Cohort 3 demonstrated a clinically meaningful and statistically significant improved response rate that was rapid and durable with EC+FOLFIRI vs control in 1L BRAF V600E-mutant mCRC, with manageable toxicities and no new safety signals. These data support EC+FOLFIRI as a potential new standard of care in BRAF V600E-mutant mCRC.

Reference: LBA3503 – ASCO 2026

Adjuvant Sintilimab-Capecitabine versus Capecitabine Alone in Locoregionally Advanced Nasopharyngeal Carcinoma with Suboptimal Response to Induction Chemotherapy: An Open-Label, Randomized, Controlled, Phase 2 Trial.

• This randomized clinical trial determining whether Sintilimab plus Capecitabine versus Capecitabine alone can improve the progression-free survival rate of NPC patients with unfavorable response to induction chemotherapy. 
• Patients whose plasma EBV DNA> 0 copy/mL or SD/PD according to RECIST1.1 after two cycles induction chemotherapy will have concurrent chemoradiotherapy. MRI, CT and EBV DNA will be assessed before the end of radiotherapy. 
• After concurrent chemoradiotherapy, eligible patients will be randomized to receive either adjuvant Sintilimab plus Capecitabine or Capecitabine alone.

Reference: LBA6005 – ASCO 2026

Ultra-Low-Dose Immunotherapy Plus Oral Metronomic Chemotherapy versus Paclitaxel-Carboplatin in Platinum-Sensitive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: A Randomized Phase III Trial.

• The regimens approved for the treatment of advanced head and neck squamous cell carcinoma are accessible to only 1%-3% of patients in low- and middle-income countries because of their cost.  
• Retrospective data suggest that a low dose of nivolumab may be efficacious.
• Limited data are available regarding the comparison of ultra low-dose immunotherapy when added to oral metronomic chemotherapy with conventional induction chemotherapy regimens in recurrent/metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC).

Reference: LBA6007 – ASCO 2026

Event-Free Survival with Adjuvant Selpercatinib in Stage IB-IIIA Fusion-Positive NSCLC: Primary Results of The Phase 3 LIBRETTO-432 Trial

• LIBRETTO-432 is a Phase 3, global, multicenter, randomized, double-blind, controlled trial evaluating efficacy and safety of adjuvant selpercatinib v Placebo in pts with RET+ Stage IB-IIIA NSCLC following completion of definitive therapies with curative intent, and other adjuvant therapy if indicated (NCT04819100). 
• Pts (n≈170) will be randomized (1:1) to selpercatinib BID [160mg ≥50kg; 120mg <50kg], or Placebo, in continuous 28-day cycles for a maximum treatment duration of 3y. Stratification factors include disease stage (IB/II/IIIA) and prior definitive therapy. Treatment will continue until disease recurrence/progression, unacceptable toxicity, or another protocol-defined reason. Crossover is allowed for Placebo pts who experience disease recurrence/progression. Key eligibility criteria include age ≥18 y; histologically confirmed Stage IB/II/IIIA NSCLC; RET+ tumor by PCR/NGS; prior definitive locoregional therapy with curative intent (surgery, radiotherapy) for Stage IB/II/IIIA NSCLC; and ECOG performance status 0-1. Maximum time allowed from definitive therapy completion to randomization is 26 w. Key exclusion criteria are evidence of other known oncogenic drivers; SCLC; and disease recurrence/progression following definitive therapy. 
• Primary endpoint is investigator-assessed event-free survival (IAEFS) in the primary analysis population (pts with Stage II-IIIA). EFS is defined as time from randomization until locoregional disease recurrence with histopathological confirmation, distant disease recurrence per RECIST v1.1 or histopathological confirmation, or death. Gated secondary endpoints include IAEFS in the overall population (pts with Stage IB-IIIA) and OS in both primary analysis and overall populations. Non-gated secondary efficacy endpoints include BICR-assessed EFS, BICR and investigator-assessed time to distant disease recurrence in the CNS, and PFS on next line of treatment. 

Reference: LBA3 – ASCO 2026

Perioperative (Neoadjuvant and Adjuvant) Apalutamide (APA) + Androgen Deprivation Therapy (ADT) vs Placebo (PBO) + ADT with Radical Prostatectomy (RP) in High-risk Localized or Locally Advanced Prostate Cancer (HR LPC/LAPC): Final Analysis of the PROTEUS Phase 3 Study

• Evaluating perioperative intensification strategy: The phase 3 PROTEUS trial is assessing whether12 months of apalutamide (APA) + ADT given before and after radical prostatectomy (RP)improves outcomes vs placebo + ADT in patients withlocalized/locally advanced high‑risk prostate cancer.
• Dual primary endpoints targeting depth and durability of response: The study evaluatespathologic complete response (pCR)&metastasis‑free survival (MFS)(including PSMA‑PET–based assessment), aiming to demonstrate bothimproved tumor eradication at surgery and delayed disease progression.
• Large, global, rigorously designed study with evolving standard‑of‑care integration: ~2000patients across 18 countries are randomized 1:1, with 6‑month neoadjuvant + 6‑month adjuvant therapy, central blinded review, and protocol updates including PSMA‑PET imaging and perioperative CV/thrombotic risk management, ensuring contemporary relevance.

Reference: LBA1 – ASCO 2026

Ivonescimab Plus Chemotherapy versus Tislelizumab Plus Chemotherapy in Previously Untreated Advanced Squamous Non-Small Cell Lung Cancer: Overall Survival Results of The Phase 3 HARMONi-6 trial.

• Median progression-free survival was 11·1 months in the ivonescimab group and 6·9 months in the tislelizumab group. The progression-free survival benefit with ivonescimab plus chemotherapy was consistent regardless of PD-L1 status. 
• 170 (64%) patients in the ivonescimab group and 144 (54%) patients in the tislelizumab group had grade 3 or higher treatment-related adverse events, with grade 3 or higher immune-related adverse events occurring in 24 (9%) patients in the ivonescimab group and in 27 (10%) patients in the tislelizumab group. Grade 3 or higher treatment-related haemorrhage occurred in five (2%) patients in the ivonescimab group and in two (1%) patients in the tislelizumab group.
• In patients with untreated advanced squamous NSCLC, ivonescimab plus chemotherapy showed significantly improved progression-free survival compared with tislelizumab plus chemotherapy, regardless of PD-L1 status, as well as a manageable safety profile. This regimen could be used as a novel first-line treatment in this patient group.

Reference: LBA4 – ASCO 2026

Daraxonrasib, a RAS(ON) Multi-Selective Inhibitor vs Chemotherapy in Previously Treated Metastatic Pancreatic Adenocarcinoma (mPDAC): Primary and Final Analysis from the Phase 3 RASolute 302 Study

• The global, randomized RASolute 302 trial enrolled approximately 501 adult patients with histologically or cytologically confirmed metastatic PDAC. Eligible patients were required to have an ECOG performance status of 0 or 1, measurable disease per RECIST v1.1 guidelines, and adequate organ function. The study protocol included patients with documented RAS mutations at codon 12, 13, or 61. Study patients were randomly assigned in a 1:1 ratio to receive either 300 mg of daraxonrasib administered orally once daily or investigator’s choice of standard cytotoxic chemotherapy. 
• This trial has met its primary and key secondary end points, demonstrating a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) for patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). 
• The oral agent approximately doubled the median OS compared with investigator’s choice of standard-of-care chemotherapy. This survival benefit was observed across the intent-to-treat population, which included patients with various RAS mutations and those with RAS wild-type disease.

Reference: LBA5 – ASCO 2026

Palbociclib Plus Tamoxifen ± Goserelin in Women with Hormone Receptor (HR)-Positive, HER2-Negative Advanced Breast Cancer (BC): PATHWAY, An Asian International Double-Blind Randomized Phase 3 Trial Final Overall Survival (OS) Analysis

• Clinically meaningful PFS benefit with P + TAM: The study met its primary endpoint, with median PFS 24.4 months vs 11.1 months for placebo + TAM, supporting palbociclib intensification with tamoxifen in HR+/HER2− ABC across menopausal status.
• Benefit consistent and notable in pre/peri‑menopausal subgroup: PFS hazard ratios favored P + TAM across stratification factors—1st‑line ET HR 0.52 and 2nd‑line ET HR 0.71; by menopausal status pre/peri‑M HR 0.38 (stronger effect) and post‑M HR 0.68—suggesting the combination is particularly impactful in pre/peri‑M patients receiving OFS.
• Safety consistent with known palbociclib profile; OS immature but encouraging: Grade ≥3 TEAEs were higher with P + TAM (93.4% vs 20.4%), driven mainly by neutropenia (89.0% vs 1.1%); no grade 5 TEAEs. OS was not reached in both arms at primary analysis, with an early favorable trend (HR 0.73).

Reference: LBA1018 – ASCO 2026

Subgroup Analyses by Disease Volume and De Novo Recurrent mHSPC in the PSMAddition Study of Lu-PSMA-617

• In the phase 3 PSMAddition study (NCT04720157), combining [¹⁷⁷Lu]Lu-PSMA-617 (¹⁷⁷Lu-PSMA-617) with ADT + ARPI significantly improved rPFS in patients with PSMA+ mHSPC vs ADT + ARPI at rPFS interim analysis (data cut off Jan 13, 2025), with a HR of 0.72 (95% CI 0.58, 0.90; p = 0.002).
• Of 572 patients randomized to the ¹⁷⁷Lu-PSMA-617 arm and 572 to the control arm, 68.0% and 68.2% had high DV, and 52.1% and 47.9% had de novo mHSPC. Efficacy and PRO HRs for the ¹⁷⁷Lu-PSMA-617 arm vs control arm were generally similar in the overall population and DV and mHSPC subgroups. Incidences of AEs, grade ≥3 AEs, serious AEs, and selected safety topics of interest (cytopenias, dry mouth) were similar across subgroups within each treatment arm.
• In patients with PSMA+ mHSPC, combining ¹⁷⁷Lu-PSMA-617 with ADT + ARPI improved rPFS vs ADT + ARPI across high/low DV and de novo/recurrent mHSPC subgroups. Other efficacy outcomes, PROs, and the safety profile were generally consistent across subgroups.

Reference: ABS5020 – ASCO 2026