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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 ↓

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Today’s batch · 10h ago · 3 of 19 shown

Nivolumab-AVD and personalized mRNA vaccines drive major advances across lymphoma, solid tumors, and melanoma.

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Oct 138 finds
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Nivolumab-AVD achieves 91% three-year PFS in advanced Hodgkin lymphoma

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.

Phase 3 winsPrecision oncologyashpublications.org · Oct 13
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GPC3-CAR T-cell therapy achieves complete remission in pediatric hepatoblastoma

A 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.

Cell & gene therapyRemarkable responsesolympiachoral.org · Oct 12
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Personalized mRNA vaccine plus Keytruda keeps melanoma patients cancer-free

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.

Cancer vaccinesvaldorge.com · Oct 12Also in wearehealthy.org, fitnesshealthandnutrition.com
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Australia launches pediatric personalized mRNA vaccine trial for brain tumors

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.

Cancer vaccinesokevt.org · Oct 11
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Tambotatug pelitecan improves survival in relapsed small-cell lung cancer

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.

Phase 3 winsnowpossible.eu · Oct 11
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FDA approves atezolizumab plus chemotherapy for stage III mismatch repair-deficient colon cancer

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.

ApprovalsPhase 3 winsonclive.com · Oct 11
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Pirtobrutinib-venetoclax-rituximab reduces progression risk in relapsed chronic lymphocytic leukemia

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.

Phase 3 winsoncodaily.com · Oct 11
Oct 1111 finds
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FDA approves atezolizumab plus chemotherapy for dMMR colon cancer

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.

ApprovalsPrecision oncologyTargeted Oncology · Oct 9Also in onclive.com
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FDA approves tucatinib maintenance for HER2-positive breast cancer

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.

ApprovalsPhase 3 winsonclive.com · Oct 9Also in news.google.com
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China's NMPA approves Dato-DXd for triple-negative breast cancer

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.

ApprovalsPrecision oncologyonclive.com · Oct 8
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Gotistobart cuts death risk 42% in squamous lung cancer

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.

Phase 3 winsPractice-changingbiosciencedesk.com · Oct 4
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Erdafitinib beats chemotherapy in FGFR-altered urothelial cancer

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.

Phase 3 winsPrecision oncologyesmoopen.com · Oct 1
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Ivonescimab meets overall survival in biliary tract cancer

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.

Phase 3 winsPractice-changingpienomial.com · Sep 29
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Pembrolizumab before surgery prevents recurrence in bowel cancer

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.

Remarkable responsessciencedaily.com · Oct 10
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Guardant360 CDx approved in EU for breast cancer selection

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.

Precision oncologyEarly detectiononclive.com · Oct 9
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FDA grants breakthrough designation to Natera multi-cancer blood test

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.

Early detectiononclive.com · Oct 9
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FDA fast track for PSV359 in solitary fibrous tumors

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.

Precision oncologyPractice-changingonclive.com · Oct 9
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