Phase 3 SWOG S1826 trial showed nivolumab-AVD achieved 91% three-year progression-free survival in EBV-positive patients versus 70% with brentuximab vedotin-AVD, and overcame poor outcomes in non-nodular sclerosis histologic subtypes. This matters because these subtypes have historically had worse prognosis.
Oncology Breakthroughs
The cancer results that change treatment: new approvals, phase 3 trials that extend survival, remarkable remissions, cell and gene therapies, cancer vaccines, early detection and precision oncology. Each find with the numbers that matter and who it could help. Topics and rules ↓
Nivolumab-AVD and personalized mRNA vaccines drive major advances across lymphoma, solid tumors, and melanoma.
Everything it found
Newest firstA 3-year-old with chemo-resistant hepatoblastoma metastasized to lungs and bones showed no remaining cancer after two doses of GPC3-CAR T-cell therapy, with no signs of disease after one year of follow-up. This demonstrates CAR-T efficacy against a solid tumor, a challenge that has limited this approach.
Five-year results showed over two-thirds of melanoma patients receiving a personalized mRNA vaccine combined with Keytruda remained cancer-free, compared to those receiving Keytruda alone. The vaccine trains T cells to target neoantigens unique to each patient's tumor.
The PaedNEO-VAX study began enrolling children and teenagers with treatment-resistant or relapsed high-grade brain tumors across eight Australian pediatric hospitals, with custom vaccines delivered approximately ten weeks after enrollment. The trial received 2.58 million Australian dollars in federal funding.
Phase 3 TAISHAN-302 randomized 451 Chinese patients with relapsed small-cell lung cancer and found tambotatug pelitecan achieved median overall survival of 13.3 months versus 9.4 months with topotecan. The antibody-drug conjugate targeting B7-H3 addresses a disease with limited second-line treatment options.
The FDA approved atezolizumab combined with modified FOLFOX6 for adjuvant treatment of stage III mismatch repair-deficient colon cancer based on phase 3 ATOMIC trial showing disease-free survival of 86.3% at 3 years versus 76.2% with chemotherapy alone (HR 0.50, P=0.0001). The approval may improve access and reimbursement for a regimen already in guidelines.
Armenia's Ministry of Health granted marketing authorizations for botensilimab and balstilimab in combination for previously treated microsatellite stable metastatic colorectal cancer without active liver metastases, based on phase 1b two-year survival findings and randomized phase 2 data. The approvals are effective as of October 2, 2026.
Phase 3 BRUIN CLL-322 trial showed pirtobrutinib combined with venetoclax and rituximab reduced progression-free survival risk versus venetoclax-rituximab alone in 639 patients with relapsed or refractory CLL, with median follow-up of 27.3 months. This is the first randomized phase 3 evidence for a fixed-duration BTK inhibitor-containing regimen in relapsed CLL.
The FDA approved atezolizumab combined with chemotherapy as adjuvant treatment for deficient mismatch repair colon cancer. This precision approach targets a molecular subtype to improve early-stage disease outcomes.
The FDA approved tucatinib combined with trastuzumab and pertuzumab for maintenance treatment of unresectable locally advanced or metastatic HER2-positive breast cancer on October 7, 2026, based on phase 3 HER2CLIMB-05 showing 35.9% reduction in disease progression or death. This expands first-line maintenance options to all HER2-positive patients regardless of hormone receptor status.
China's NMPA approved the antibody-drug conjugate Dato-DXd for metastatic triple-negative breast cancer in patients ineligible for PD-(L)1 inhibitor therapy. This expands treatment options for a difficult-to-treat cancer subtype.
Gotistobart, an anti-CTLA-4 antibody, achieved 18.5 months median overall survival versus 10.0 months for docetaxel in phase 3 PRESERVE-003 (388 patients, HR 0.58, p=0.0001), presented at WCLC 2026. This result revives the anti-CTLA-4 class after 15 years of dormancy in a tumor type resistant to most novel therapies.
Erdafitinib achieved 12.1 months median overall survival and 46.9% response rate versus 8.7 months and 12.6% for chemotherapy in phase 3 THOR cohort 1 (FGFR3/2-altered metastatic urothelial cancer after anti-PD-(L)1 failure). This precision result supports erdafitinib use in biomarker-selected patients with limited post-immunotherapy options.
Ivonescimab plus chemotherapy met overall survival primary endpoint versus durvalumab plus chemotherapy in phase 3 HARMONi-GI1 for first-line advanced biliary tract cancer, selected as late-breaking abstract for ESMO 2026 (October 23–27). Beating an active immunotherapy standard rather than placebo represents a materially harder regulatory test.
In NEOPRISM-CRC, 32 patients with a specific genetic form of stage 2–3 bowel cancer received pembrolizumab for up to nine weeks before surgery; after nearly three years, none experienced recurrence, including those with residual disease. This durable protection from neoadjuvant immunotherapy alone challenges the standard post-surgery chemotherapy approach in this biomarker-selected population.
The FDA approved Roche's Tecentriq (atezolizumab) for colon cancer, its first indication in this disease.
Guardant360 CDx, a blood test detecting ESR1 mutations, received European approval as a companion diagnostic for camizestrant in ER-positive, HER2-negative advanced breast cancer. In phase 3 SERENA-6, patients switched to camizestrant achieved median progression-free survival of 16.0 months versus 9.2 months with continued aromatase inhibition.
The FDA granted breakthrough device designation to Natera's multi-cancer early detection assay, a blood test analyzing cell-free DNA across 12 cancer types. Breakthrough designation enables prioritized review but does not constitute approval.
The FDA granted fast track designation to PSV359, a lead-212 alpha radiopharmaceutical targeting FAP-positive tumors, for locally advanced unresectable or metastatic solitary fibrous tumors. A phase 1/2a study reported no dose-limiting toxicities and only grade 1–2 adverse effects in 17 patients across three dose cohorts.
GPC3-CAR T-cell therapy achieves complete remission in pediatric hepatoblastoma
Oncology Breakthroughs · today, 09:04A 3-year-old with chemo-resistant hepatoblastoma that had metastasized to lungs and bones achieved complete remission after two doses of GPC3-CAR T-cell therapy, with no signs of disease after one year of follow-up. The experimental treatment genetically engineers the patient's T cells to target glypican-3, a protein on hepatoblastoma cells. This case demonstrates CAR-T efficacy against a solid tumor, a challenge that has limited this approach historically. The CARE study at Baylor College of Medicine is continuing to test GPC3-CAR treatment in pediatric patients with recurrent solid tumors, offering a potential new path for children with liver cancer who fail conventional chemotherapy and surgery.