Cancer immunotherapy and targeted therapy advances
Key Questions
What is the first CAR-T approval for a solid tumor?
The first CAR-T approval for a solid tumor (gastric cancer) occurred in China, expanding options beyond hematologic cancers.
How effective is daraxonrasib in pancreatic cancer?
Daraxonrasib nearly doubles pancreatic cancer survival, with the vopimetostat combo achieving 92% response rate.
What long-term data supports KEYNOTE-942?
KEYNOTE-942 5-year data shows 49% reduction in recurrence with the mRNA vaccine approach in melanoma.
What CAR-T results were seen in glioblastoma?
CAR-T delivered via spinal fluid led to complete tumor disappearance in glioblastoma cases.
Which new approvals occurred for NSCLC and bile duct cancer?
FDA approved zidesamtinib for ROS1+ NSCLC and rilafugratinib for FGFR2-mutated bile duct cancer.
How does the gut microbiome influence cancer immunotherapy?
Aggressive cancer patients had 82% less Bifidobacterium in the gut, and a gut bacteria molecule doubles lung cancer immunotherapy response.
What durable responses were achieved with allogeneic CAR-T in solid tumors?
ALLO-316 achieved first durable remissions in solid tumors like RCC with 31% response and 25% ORR in the TRAVERSE trial.
What repurposing opportunity exists for AMD3100 in fibrolamellar carcinoma?
FDA-approved AMD3100 shows potential to overcome T-cell exclusion in this rare liver cancer by targeting stellate cells, based on ex vivo data.
First CAR-T approval for solid tumor (gastric cancer) in China. Daraxonrasib nearly doubles pancreatic cancer survival (6.7→13.2 months) via molecular glue mechanism; FDA accelerated review expected 2026. CAR-T for glioblastoma via spinal fluid leads to complete tumor disappearance. TAA-T cell therapy for DIPG shows three children with no evidence of disease up to 5 years. Access barriers: only 20-25% of eligible lymphoma patients receive CAR-T. Off-the-shelf CAR-T developers target access gap; vispa-cel shows 82% ORR, 67% CR in 2L LBCL. Germline genetics influence CAR-T safety/efficacy. Teclistamab and cilta-cel show PFS/OS benefit in RRMM. SMARCA4-dNSCLC responds to ICI chemoimmunotherapy. Dual TIGIT/PD-1 blockade yields 17.2% ORR in ICI-refractory HCC. Phase III trial of live biotherapy MO-03 with immunotherapy underway. New: Enfortumab vedotin + pembrolizumab FDA approved for MIBC (47% lower risk of progression). New: Dato-DXd + pembrolizumab shows >50% response in treatment-naive NSCLC. New: amfAR commits $1.92M for HIV cure studies. New: Early CAR-T therapy in AML shows complete remissions. New: Sumitomo's enzomenib receives FDA orphan designation for ALL. New: Vaccine to prevent pancreatic cancer (mKRAS-VAX) shows 90% immune response, lesion resolution in early trial. New: Vista trial begins dosing ITOP1 precision cancer vaccine for esophageal adenocarcinoma. New: Adjuvant immunotherapy in early lung cancer continues to fail; field shifting to neoadjuvant (CheckMate 816, KEYNOTE-671). New: ICI+chemo outperforms bevacizumab+chemo in first-line non-squamous NSCLC (retrospective study). New: J&J options in vivo CAR-T maker Sail for $2.58B, signaling next-gen cell therapy. New: AI in cancer immunotherapy overview (LORIS, SCORPIO models). New: RP1 + nivolumab shows 33.6% ORR, 16.4% CR in anti-PD-1 refractory melanoma; FDA panel votes 10-3 for efficacy. New: In vivo CAR gene therapy review highlights promise and safety concerns. New: Immunogenomic classification of solid tumours refines patient selection for ICB therapy. New: First UK patient dosed with personalized lung cancer vaccine using Touchlight's dbDNA platform (Phase I). New: Kelun-Biotech's Sac-TMT gains NMPA review for first-line advanced TNBC, expanding ADC momentum. New: CAR NK therapy advance: immature cord blood NK subset drives trogocytosis; depleting it enhances function. New: NanoKar Therapeutics builds next-gen CAR-T platform for multiple cancers. New: CREATE acquires Monash's TP1107 LNP capture system to solve in vivo CAR-T liver tropism, 8-fold increase in target cell binding. New: clinTALL precision medicine tool for pediatric T-ALL using machine learning. New: Practical CAR T use in multiple myeloma preview highlights operational workflows, access barriers, and sequencing. New: CMC strategic priority: 74% of FDA CRLs from quality/manufacturing issues; early CMC planning and AI-driven process control critical for therapy access. New: CAR-T for T-ALL/T-LL: off-the-shelf, 91% ORR, 72.7% CR in heavily pretreated, enabling transplant access. New: Beyond PD-L1/TMB: TME, TLS, ctDNA emerging as biomarkers for immunotherapy response. New: Complement C3 local vs systemic role in immunotherapy; potential to identify patients and mimic effect. New: Clinical trial launched for KRAS G12D inhibitor VS-7375 at NYU for solid tumors. New: mRNA personalized vaccines for breast cancer emerging as potential paradigm shift. New: Therapeutic mRNA vaccines for HIV reviewed, highlighting self-amplifying RNA and LNP delivery innovations. New: FDA approved Pluvicto (177Lu-PSMA-617) for earlier use in PSMA-positive mHSPC, showing 28% reduction in progression/death risk, nearly doubling eligible patient population. New: PROTAC-controlled CAR T cells offer reversible safety switch, addressing on-target off-tumor toxicity. New: mRNA therapeutics beyond vaccines expanding into cancer and rare genetic diseases, reinforcing platform potential. New: CRISPR-edited donor stem cells (CD33 removal) combined with CD33-targeted maintenance therapy shows engraftment and stable counts in AML/MDS. New: Cevostamab bispecific antibody shows >40% response in Phase I multiple myeloma. New: Olomorasib (KRAS G12C inhibitor) gets second Breakthrough Therapy for pancreatic cancer. New: TUSC2 gene therapy in NSCLC shows TROP2 as predictive biomarker for nanoparticle uptake, enabling AI-guided patient selection. New: Checkpoint inhibitors not contraindicated in all interstitial lung disease, nuanced guidance. New: CLL CAR-T bridge therapy with pirtobrutinib shows real-world sequencing signal. New: IL-10–expressing CAR T-cell therapy in DLBCL shows 84.6% CR with ultra-low dosing in Phase I. New: Microbiome modulation with metronidazole boosts chemotherapy delivery via bile acid/Kupffer cell mechanism (preclinical). New: Inherited genetic variants (STXBP2, ADAMTSL3, PTPN22) influence CAR T toxicity and expansion, adding personalized medicine layer to cell therapy. New: R-Pola-Glo shows 90% response and 81% CR in frail older DLBCL with QoL improvements. New: Amplia Therapeutics partners with Lilly on FAK inhibitor narmafotinib to overcome KRAS G12C resistance in NSCLC. New: Endobronchial intratumoral delivery of immuno/gene therapies for NSCLC reviewed as potential local approach. Recent articles: Targeting FcRH5 in multiple myeloma (early CAR-T perspective) and TNBC immunotherapy guide (2026) reinforce momentum.