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    Cancer immunotherapy tracker: approvals and trial results

    This tracker logs the milestones shaping cancer immunotherapy, from checkpoint inhibitors to CAR-T, bispecifics and personalised mRNA vaccines.[1] As of 10 October 2026 the latest entries are an FDA approval of adjuvant atezolizumab in dMMR colon cancer and positive survival data for the PD-1 x VEGF bispecific ivonescimab.[2][3]

    Editor reviewedStrict sourcingUpdated Cancer immunotherapyHealth and medicineLife sciences

    What we know

    • The first checkpoint inhibitor, ipilimumab, was approved by the FDA in 2011.[4]
    • A personalised mRNA vaccine plus Keytruda met its phase 3 endpoints in resected melanoma (August 2026).[7]
    • China approved satri-cel, described as the first CAR-T for a solid tumour, on 22 June 2026.[11]
    • The FDA eliminated REMS safety programmes for autologous CAR-T therapies on 26 June 2025.[26]
    • The first engineered T-cell receptor therapy, Tecelra, was FDA-approved for synovial sarcoma in August 2024.[10]
    • A subcutaneous form of pembrolizumab, Keytruda Qlex, was FDA-approved in September 2025.[15]
    • An FDA decision on ivonescimab in EGFR-mutated lung cancer is due by 14 November 2026.[22]

    What we don't know yet

    • The size of the INTerpath-001 recurrence-free survival benefit and whether overall survival improves.
    • Whether the FDA approves ivonescimab, and on what label.
    • Whether in vivo CAR-T can be made safe and durable enough for larger trials.
    • Whether solid-tumour CAR-T such as satri-cel will be approved outside China.
    • Whether personalised vaccines work in cancers other than melanoma, after the colorectal setback.
    Story status

    Story status

    State
    developing
    Started
    2011-03-25
    Timeline entries
    31
    Last entry

    Timeline data (JSON)

    This tracker follows cancer immunotherapy as a live field. Entries are dated to the regulatory action, publication or company announcement, and each is tagged by how well it is confirmed.[1] The modern era is dated from the first checkpoint inhibitor approval, of ipilimumab on 25 March 2011.[4][5] The discoveries behind checkpoint blockade won James P. Allison and Tasuku Honjo the 2018 Nobel Prize in Physiology or Medicine.[6]

    Where things stand (10 October 2026)

    Checkpoint inhibitors keep moving into earlier disease, most recently adjuvant atezolizumab in stage III dMMR colon cancer.[2] Personalised mRNA vaccines have their first phase 3 win, in melanoma, and a fresh setback in colorectal cancer.[7][8] PD-1 x VEGF bispecifics have reported overall-survival gains against PD-1 standards.[3][9]

    Cell therapy is edging into solid tumours. The US approved an engineered T-cell receptor product, Tecelra, for synovial sarcoma in 2024, and China approved the claudin-18.2 CAR-T satri-cel for gastric cancer on 22 June 2026.[10][11] In vivo CAR-T, which would skip lab manufacturing, has early myeloma data with serious toxicity, and a preclinical gene-editing route reported in Nature in March 2026.[12][13]

    Treatment is also shifting earlier and becoming easier to give. The NADINA trial showed that two doses of ipilimumab plus nivolumab before surgery improved event-free survival in stage III melanoma, and Keytruda Qlex lets pembrolizumab be injected under the skin.[14][15] In children with high-risk B-cell leukaemia, the T-cell engager blinatumomab replaced two chemotherapy cycles and improved event-free survival in a 2026 NEJM trial.[16]

    Scale and limits

    Checkpoint inhibitors are now big medicine: Merck’s pembrolizumab recorded $31.7 billion in sales in 2025.[17] But benefit is narrower than use. A 2019 study estimated that 43.6% of US cancer patients were eligible for a checkpoint inhibitor in 2018 and only about 12.5% would respond.[18] Combinations are one answer: enfortumab vedotin plus pembrolizumab roughly doubled median overall survival in untreated advanced bladder cancer (31.5 vs 16.1 months).[19] Toxicity is the recurring cost. In MajesTEC-3, teclistamab-daratumumab brought more serious adverse events than standard therapy (70.7% vs 62.4%), and in the satri-cel trial 99% of treated patients had grade 3 or higher events.[20][21]

    What to watch next

    • 14 November 2026: FDA goal date for ivonescimab in EGFR-mutated lung cancer.[22]
    • INTerpath-001 full data: presentation at a medical meeting and regulatory filings were promised.[23]
    • Autogene cevumeran in pancreatic cancer: the IMcode003 trial continues.[8]
    • In vivo CAR-T: peer-reviewed data and larger trials for KLN-1010 and others.[24]
    • Satri-cel outside China: whether the first solid-tumour CAR-T is filed or approved elsewhere.[11]
    • Confirmatory evidence: the accelerated approval of vusolimogene oderparepvec requires post-approval trials.[25]

    How entries are tagged

    Confirmed entries rest on regulator notices, peer-reviewed papers or the sponsor’s own announcement of its trial. The REMS removal is dated to the FDA’s own notice of 26 June 2025.[26] Reported entries rest on conference data covered by trade media and not yet peer-reviewed.[24]

    Timeline

    30 confirmed1 reported

    1. confirmed

      FDA approves adjuvant atezolizumab plus chemotherapy in stage III dMMR colon cancer[2]

    2. confirmed

      Ivonescimab beats pembrolizumab on overall survival in HARMONi-2[3]

    3. confirmed

      Blinatumomab replacing chemotherapy improves event-free survival in children with high-risk B-ALL (NEJM)[16]

    4. confirmed

      BioNTech ends colorectal trial of autogene cevumeran after overall-survival imbalance[8]

    5. confirmed

      Personalised mRNA therapy intismeran autogene meets phase 3 endpoints in melanoma[7]

    6. confirmed

      FDA grants accelerated approval to oncolytic virus vusolimogene oderparepvec with nivolumab in melanoma[25]

    7. confirmed

      FDA approves sacituzumab govitecan with pembrolizumab in first-line triple-negative breast cancer[41]

    8. confirmed

      China approves satri-cel, first CAR-T for a solid tumour[11][40]

    9. reported

      Kelonia reports MRD-negative responses in 18 patients with in vivo CAR-T KLN-1010 at ASCO[24]

    10. confirmed

      Ivonescimab beats tislelizumab-chemotherapy on overall survival in HARMONi-6[9]

    11. confirmed

      Phase 1 report of in vivo CAR-T ESO-T01 in myeloma published in Nature Medicine[39][12]

      Four of five patients responded; all had grade 3 or higher adverse events and one died.

    12. confirmed

      In vivo CRISPR insertion of a CAR gene generates CAR-T cells in mice (Nature)[13]

    13. confirmed

      FDA approves teclistamab plus daratumumab in earlier-line myeloma[38]

    14. confirmed

      Individualised mRNA vaccine shows durable T-cell responses in triple-negative breast cancer (Nature, single arm)[29]

    15. confirmed

      FDA accepts ivonescimab application with 14 November 2026 goal date[22]

    16. confirmed

      Shared-neoantigen vaccine Nous-209 induces immune responses in Lynch syndrome carriers (Nature Medicine)[28]

    17. confirmed

      MajesTEC-3 teclistamab-daratumumab results published in NEJM[20]

    18. confirmed

      FDA approves first CAR-T therapy for marginal zone lymphoma[37]

    19. confirmed

      FDA approves subcutaneous pembrolizumab (Keytruda Qlex)[15]

    20. confirmed

      Tarlatamab improves overall survival in phase 3 DeLLphi-304 (NEJM)[36]

    21. confirmed

      FDA eliminates REMS requirements for autologous CAR-T therapies[26][35]

    22. confirmed

      Randomised trial of claudin-18.2 CAR-T satri-cel in gastric cancer published in The Lancet[34]

    23. confirmed

      FDA approves Tecelra, the first engineered T-cell receptor therapy, in synovial sarcoma[10]

    24. confirmed

      NADINA shows neoadjuvant ipilimumab plus nivolumab improves event-free survival in stage III melanoma (NEJM)[14]

    25. confirmed

      FDA grants accelerated approval to tarlatamab, a DLL3 x CD3 T-cell engager, in small cell lung cancer[33]

    26. confirmed

      FDA requires boxed warning for T-cell malignancies on CAR-T products[32]

    27. confirmed

      FDA approves lifileucel, the first tumour-derived T-cell therapy, for advanced melanoma[31]

    28. confirmed

      KEYNOTE-942 phase 2b results for mRNA-4157 plus pembrolizumab published in The Lancet[30]

    29. confirmed

      FDA approves enfortumab vedotin plus pembrolizumab in advanced urothelial cancer (EV-302)[27][19]

    30. confirmed

      Allison and Honjo win the Nobel Prize for checkpoint-blockade cancer therapy[6]

    31. confirmed

      FDA approves ipilimumab (Yervoy), the first immune checkpoint inhibitor, for advanced melanoma[5][4]

    Questions readers ask

    What is the most important recent cancer immunotherapy result?

    Several compete. In August 2026 a personalised mRNA vaccine plus Keytruda met phase 3 endpoints in melanoma, and in September 2026 ivonescimab beat pembrolizumab on overall survival in HARMONi-2.[7][3]

    What regulatory decision is coming next?

    The FDA's decision on ivonescimab plus chemotherapy in EGFR-mutated non-squamous lung cancer after TKI therapy, with a goal date of 14 November 2026.[22]

    Have there been setbacks?

    Yes. BioNTech ended a colorectal trial of its personalised vaccine in August 2026, and in the in vivo CAR-T trial of ESO-T01, which was stopped early in 2025, all five patients had grade 3 or higher adverse events and one died.[8][12]

    Sources

    Each numbered claim is a statement we checked against the sources listed with it. Status shows how well established it is.

    1. [1]

      NCI lists the main types of cancer immunotherapy as immune checkpoint inhibitors, T-cell transfer therapy, monoclonal antibodies, treatment vaccines and immune system modulators. confirmedas of 2026-10-10

    2. [2]

      On 8 October 2026 the FDA approved atezolizumab plus chemotherapy as adjuvant treatment for stage III mismatch repair deficient colon cancer, based on the ATOMIC trial (disease-free survival hazard ratio 0.50). confirmedas of 2026-10-08

    3. [3]

      Akeso reported in September 2026 that its PD-1 x VEGF bispecific ivonescimab extended median overall survival to 30.8 months versus 22.6 months with pembrolizumab in first-line PD-L1-positive non-small cell lung cancer in the HARMONi-2 trial (hazard ratio 0.73). confirmedas of 2026-09-13

    4. [4]

      Ipilimumab (Yervoy), which blocks CTLA-4, became the first immune checkpoint inhibitor approved by the FDA, in 2011, for unresectable or metastatic melanoma. confirmedas of 2026-10-10

    5. [5]

      Drugs@FDA records the original approval of Yervoy (ipilimumab), BLA 125377, on 25 March 2011. confirmedas of 2011-03-25

    6. [6]

      The 2018 Nobel Prize in Physiology or Medicine was awarded jointly to James P. Allison and Tasuku Honjo for their discovery of cancer therapy by inhibition of negative immune regulation, the basis of CTLA-4 and PD-1 checkpoint blockade. confirmedas of 2018-10-01

    7. [7]

      Merck and Moderna announced on 19 August 2026 that the 1,137-patient phase 3 INTerpath-001 trial of intismeran autogene plus Keytruda in resected stage IIB-IV melanoma met its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival versus Keytruda alone. confirmedas of 2026-08-19

    8. [8]

      On 28 August 2026 BioNTech ended a phase 2 trial of autogene cevumeran monotherapy in resected colorectal cancer after its data monitoring board saw a numerical overall-survival imbalance between arms; the pancreatic cancer trial IMcode003 continues. confirmedas of 2026-08-28

    9. [9]

      Akeso reported that in the 532-patient phase 3 HARMONi-6 trial in squamous non-small cell lung cancer, ivonescimab plus chemotherapy reduced the risk of death by 34% versus tislelizumab plus chemotherapy (hazard ratio 0.66); results were presented at the ASCO 2026 plenary. confirmedas of 2026-05-31

    10. [10]

      In August 2024 the FDA approved Tecelra (afamitresgene autoleucel) for adults with unresectable or metastatic synovial sarcoma expressing the MAGE-A4 antigen after prior chemotherapy, the first FDA-approved T-cell receptor (TCR) gene therapy. confirmedas of 2024-08-02

    11. [11]

      CARsgen announced on 22 June 2026 that China's NMPA had approved satri-cel that day for Claudin18.2-positive, HER2-negative advanced gastric or gastro-oesophageal junction adenocarcinoma after at least two prior lines of therapy. confirmedas of 2026-06-22

    12. [12]

      All five ESO-T01 patients had grade 3 or higher adverse events, four had cytokine release syndrome, one patient died from lesion-related spinal cord compression, and the trial was stopped early in 2025. confirmedas of 2026-04-01

    13. [13]

      A 2026 Nature study used CRISPR-Cas9 delivered in vivo with a DNA template to insert a CAR gene at a T-cell-specific site, generating therapeutic levels of CAR-T cells in humanised mouse models; it was a preclinical study. confirmedas of 2026-03-18

    14. [14]

      In the phase 3 NADINA trial of 423 patients with resectable stage III melanoma, two cycles of neoadjuvant ipilimumab plus nivolumab before surgery gave 12-month event-free survival of 83.7% versus 57.2% with surgery followed by adjuvant nivolumab (hazard ratio 0.32). confirmedas of 2024-06-02

    15. [15]

      On 19 September 2025 the FDA approved Keytruda Qlex, pembrolizumab with berahyaluronidase alfa for subcutaneous injection, for the solid-tumour indications of intravenous pembrolizumab in adults and children 12 and older, based on a 377-patient lung cancer trial showing comparable drug exposure. confirmedas of 2025-09-19

    16. [16]

      In a 2026 NEJM trial of 709 children with newly diagnosed high-risk B-cell acute lymphoblastic leukaemia, replacing two chemotherapy cycles with the CD19 x CD3 T-cell engager blinatumomab gave estimated 4-year event-free survival of 83.0% versus 70.3% at a planned interim analysis (hazard ratio 0.51), with fewer treatment-related infections (23.9% vs 69.4%) but more neurotoxic events (12.0% vs 3.2%). confirmedas of 2026-09-01

    17. [17]

      Merck reported 2025 worldwide sales of $31.7 billion for its PD-1 inhibitor Keytruda (pembrolizumab), including the subcutaneous Keytruda Qlex. confirmedas of 2026-02-03

    18. [18]

      A 2019 study estimated that 43.6% of US patients with cancer were eligible for checkpoint inhibitors in 2018 but only about 12.5% would respond to them. confirmedas of 2019-05-03

    19. [19]

      In the phase 3 EV-302 trial of 886 patients with previously untreated advanced urothelial cancer, enfortumab vedotin plus pembrolizumab roughly doubled median overall survival versus platinum chemotherapy (31.5 vs 16.1 months; hazard ratio 0.47) and progression-free survival (12.5 vs 6.3 months). confirmedas of 2024-03-01

    20. [20]

      In the phase 3 MajesTEC-3 trial (NEJM, December 2025), estimated 36-month progression-free survival was 83.4% with teclistamab-daratumumab versus 29.7% with standard daratumumab-based regimens; serious adverse events occurred in 70.7% versus 62.4%, and death from adverse events in 7.1% versus 5.9%. confirmedas of 2025-12-09

    21. [21]

      In the satri-cel trial, grade 3 or higher adverse events occurred in 99% of satri-cel patients versus 63% of controls, and cytokine release syndrome in 95% of treated patients. confirmedas of 2026-06-22

    22. [22]

      The FDA accepted Summit Therapeutics' application for ivonescimab plus chemotherapy in EGFR-mutated non-squamous non-small cell lung cancer after TKI therapy, with a decision goal date of 14 November 2026. confirmedas of 2026-01-29

    23. [23]

      Merck and Moderna reported no new safety signals in INTerpath-001 and said they plan to present the data at a medical meeting and engage regulators on filings; full results had not been published as of the announcement. confirmedas of 2026-08-19

    24. [24]

      Conference data on Kelonia's in vivo BCMA CAR-T candidate KLN-1010 reported minimal residual disease negativity at one month in every myeloma patient presented, four at ASH 2025 and 18 at ASCO 2026; the data are early and not yet peer-reviewed. reportedas of 2026-06-02

    25. [25]

      On 6 August 2026 the FDA granted accelerated approval to Replimune's oncolytic virus vusolimogene oderparepvec (Tudriqev) with nivolumab for advanced melanoma that progressed on PD-1 therapy; 24.2% of 91 evaluable patients responded, and confirmatory trials are required. confirmedas of 2026-08-06

    26. [26]

      On 26 June 2025 the FDA announced that the REMS programmes for approved BCMA- and CD19-directed autologous CAR-T therapies had been eliminated, saying a REMS was no longer necessary to ensure their benefits outweigh their risks. confirmedas of 2025-06-26

    27. [27]

      On 15 December 2023 the FDA approved enfortumab vedotin with pembrolizumab for locally advanced or metastatic urothelial cancer, based on EV-302. confirmedas of 2023-12-15

    28. [28]

      In a 2026 phase 1b/2 trial in 45 people with Lynch syndrome, a hereditary cancer syndrome, the off-the-shelf neoantigen vaccine Nous-209, which encodes 209 frameshift neoantigens shared across mismatch-repair-deficient tumours, caused no intervention-related serious adverse events and induced neoantigen-specific immune responses in all 37 evaluable participants, still detectable at one year in 85%. confirmedas of 2026-01-16

    29. [29]

      In a 2026 Nature report on 14 patients with triple-negative breast cancer given an individualised neoantigen mRNA vaccine after standard treatment, vaccine-induced T-cell responses persisted for years and 11 patients remained relapse-free for up to six years; the study had no control group. confirmedas of 2026-02-18

    30. [30]

      In the randomised phase 2b KEYNOTE-942 trial of 157 patients with resected melanoma, mRNA-4157 plus pembrolizumab lengthened recurrence-free survival versus pembrolizumab alone (hazard ratio 0.561), with 18-month recurrence-free survival of 79% versus 62%. confirmedas of 2024-02-01

    31. [31]

      On 16 February 2024 the FDA approved lifileucel (Amtagvi), the first tumour-derived T-cell therapy, for advanced melanoma after PD-1 treatment; 31.5% of 73 patients at the recommended dose responded. confirmedas of 2024-02-16

    32. [32]

      In April 2024 the FDA required a boxed warning on six approved BCMA- or CD19-directed autologous CAR-T products for the risk of T-cell malignancies, and said patients should be monitored life-long for secondary cancers. confirmedas of 2024-04-18

    33. [33]

      On 16 May 2024 the FDA granted accelerated approval to tarlatamab (Imdelltra), a DLL3 x CD3 bispecific T-cell engager, for extensive-stage small cell lung cancer after platinum chemotherapy; 40% of 99 patients responded. confirmedas of 2024-05-16

    34. [34]

      In a randomised phase 2 trial of 156 patients with previously treated claudin-18.2-positive gastric or gastro-oesophageal junction cancer, the CAR-T therapy satri-cel extended median progression-free survival to 3.25 months versus 1.77 months with physician's choice (hazard ratio 0.37). confirmedas of 2025-06-01

    35. [35]

      In June 2025 the FDA removed the REMS safety programmes for approved autologous CAR-T therapies, cutting the recommended stay near a treatment centre from four weeks to two and the driving restriction from eight weeks to two. confirmedas of 2025-10-02

    36. [36]

      In the phase 3 DeLLphi-304 trial of 509 patients, tarlatamab extended median overall survival to 13.6 months versus 8.3 months with chemotherapy (hazard ratio 0.60), with fewer grade 3 or higher adverse events (54% vs 80%). confirmedas of 2025-07-24

    37. [37]

      On 4 December 2025 the FDA approved lisocabtagene maraleucel (Breyanzi) as the first CAR T-cell therapy for marginal zone lymphoma; 95.5% of 66 treated patients responded. confirmedas of 2025-12-04

    38. [38]

      On 5 March 2026 the FDA approved teclistamab, a BCMA x CD3 bispecific antibody, with daratumumab for relapsed or refractory myeloma after one prior line, based on the 587-patient MajesTEC-3 trial (progression-free survival hazard ratio 0.17). confirmedas of 2026-03-05

    39. [39]

      In a phase 1 study of ESO-T01 in five patients with relapsed or refractory multiple myeloma, four responded, including three stringent complete remissions. confirmedas of 2026-04-01

    40. [40]

      In June 2026 China's NMPA approved CARsgen's satri-cel for claudin-18.2-positive, HER2-negative advanced gastric or gastro-oesophageal junction cancer, described as the first CAR T-cell therapy approved for a solid tumour. confirmedas of 2026-09-01

    41. [41]

      On 24 June 2026 the FDA approved the Trop-2-directed ADC sacituzumab govitecan with pembrolizumab for first-line PD-L1-positive metastatic triple-negative breast cancer; median progression-free survival was 11.2 versus 7.8 months in ASCENT-04. confirmedas of 2026-06-24

    Revision history (2)
    1. Page created.
    2. Refresh: added earlier landmark entries (ipilimumab approval date, 2018 Nobel, EV-302, NADINA, Tecelra, Keytruda Qlex), 2026 vaccine, in vivo CAR-T and blinatumomab papers; corrected the REMS removal date to 26 June 2025 per the FDA notice; added CARsgen's satri-cel announcement.

    Created Oct 10, 2026. Last reviewed by an editor on Oct 10, 2026. Next scheduled review: Dec 10, 2026.

    Cite this page

    "Cancer immunotherapy tracker: approvals and trial results." ContentLora, updated Oct 10, 2026. https://contentlora.com/events/cancer-immunotherapy-tracker

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