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companiesCompany
Gilead Sciences (incl. Kite)
Gilead owns Trodelvy (via the $21B Immunomedics deal) and the Kite CAR-T franchise.
Overview
Gilead Sciences, based in Foster City, California, and listed as GILD, owns Trodelvy through its 21 billion dollar purchase of Immunomedics and the Kite CAR-T franchise. Sacituzumab govitecan is approved in triple-negative breast cancer, with first-line use from 2026, and in HR-positive breast cancer; Yescarta and Tecartus are its CAR-T products, proved in ZUMA-1, ZUMA-2 and ZUMA-7; anitocabtagene autoleucel, a BCMA CAR-T from Arcellx, is in registration; and domvanalimab, its TIGIT antibody, largely failed. OnCo links it to the ASCENT paper, to the TROP2 ADC roadmap, to magrolimab and idelalisib, to the CD73 adenosine axis, and to partners including Arcellx, Kymera, Tubulis and Tmunity. Whether an oncology business built by acquisition can generate its own next products is the open question. Sacituzumab govitecan and axicabtagene ciloleucel have their own pages.
Headquarters
Foster City, CA, US
Scorecard
All companies#25of 1244 companies, score 96
- approved products +24
- phase 3 +9
- targets +10
- modalities +10
- regions +6
- 24-month regulatory events +10
- registry trials +30
- failures -3
4 approved, 3 in phase 3, 0 earlier, 5 targets, 283 registry studies. Formula on the scorecards page.
Financial snapshot, FY2024
- Oncology revenue
- $3.3bn
- Total revenue
- $28.8bn
- R&D spend
- $5.9bn
- Cash
- $10.0bn
Oncology as Gilead reports it: Trodelvy plus Cell Therapy (Yescarta and Tecartus). Cash includes marketable securities. Gilead Sciences Form 10-K, FY2024 (SEC EDGAR)
Deals
Deal map| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2020-09-13 | Immunomedics to Gilead Sciences (incl. Kite) Sacituzumab govitecan (Trodelvy), TROP2 ADC | Acquisition | not disclosed | $21bn | source |
| 2020-03-02 | Forty Seven to Gilead Sciences (incl. Kite) Magrolimab, anti-CD47 antibody | Acquisition | not disclosed | $4.9bn | source |
Catalysts
What is due next- 2027expectedASCENT-07: sacituzumab govitecan versus chemotherapy, first-line HR-positive HER2-negative metastatic breast cancer
Tests the ADC as the first chemotherapy after endocrine therapy. Timing is a registry-based estimate. Source
Manufacturing
Capacity map- Kite El Segundo El Segundo, California, USCell therapy
- Kite Frederick Frederick, Maryland, USCell therapy, Viral vector
- Kite Hoofddorp Hoofddorp, NLCell therapy
- Cellares Smart Factory South San Francisco, California, US · CellaresCell therapy
Type
Large pharma · GILD
Stage
Public
Website
ApprovedADC
Sacituzumab govitecan · Trodelvy
The first TROP2-targeted ADC. It delivers a strong chemotherapy directly to breast and bladder cancer cells and is now a first-line option in triple-negative breast cancer.
ApprovedCAR-T (CD19)
Axicabtagene ciloleucel · Yescarta
A CD19 CAR-T that cures about 40% of patients with large B-cell lymphoma who had failed everything, and beat transplant in second line.
Phase 3monoclonal antibody
Domvanalimab is an experimental monoclonal antibody from Gilead Sciences in phase 3 trials for non-small-cell lung cancer, bladder & urothelial cancer and head and neck squamous cell carcinoma, with its target not yet stated publicly.
Phase 3not stated (registered as a drug or biological on ClinicalTrials.gov)
Quemliclustat is an experimental investigational agent whose form is not stated in the registry from Arcus Biosciences in phase 3 trials for pancreatic ductal adenocarcinoma and non-small-cell lung cancer, with its target not yet stated publicly.
Phase 3CAR-T (BCMA, D-domain binder)
Anitocabtagene autoleucel is a BCMA CAR-T whose binder is a small synthetic D-domain protein rather than an antibody fragment, a design chosen for low immunogenicity. In heavily pretreated myeloma it produced responses in 97% of patients with mostly low-grade cytokine release syndrome and no delayed parkinsonism reported, and an FDA decision is due on 27 December 2026.
ApprovedAutologous CD19 CAR-T (CD28 costimulatory domain)
Brexucabtagene autoleucel · Tecartus
Brexucabtagene autoleucel is the CAR-T therapy for mantle cell lymphoma and adult acute lymphoblastic leukaemia, giving long remissions after BTK inhibitors fail.
ApprovedSmall-molecule PI3Kδ inhibitor
Idelalisib · Zydelig
Idelalisib was the first PI3K inhibitor for blood cancers; it is effective in CLL with rituximab but so toxic (colitis, hepatitis, pneumonitis, infections) that the class has largely been abandoned.
WithdrawnMonoclonal antibody (anti-CD47)
The first 'don't eat me' signal blocker. Gilead paid $4.9B for it; it was stopped in 2024 after trials showed more deaths, not fewer.
rctLancet Oncology 2022changed practice
Axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trial
Axicabtagene ciloleucel as an option in relapsed follicular and marginal zone lymphoma. Compared with tisagenlecleucel in ELARA, the response rates are higher and the neurological toxicity substantially greater, which is the trade-off a patient and centre weigh.
rctNew England Journal of Medicine 2022changed practice1,342 citations
ZUMA-7: axi-cel CAR-T instead of salvage chemotherapy and transplant for large B-cell lymphoma that relapses early
ZUMA-7 rewrote second-line treatment for aggressive lymphoma: patients whose disease returns within a year of R-CHOP should be offered CAR-T rather than salvage chemotherapy and transplant. It is also one of the few cell-therapy trials to show an overall survival benefit despite crossover. Patients relapsing later than 12 months were not studied and transplant remains standard for them if chemosensitive.
rctNew England Journal of Medicine 2021changed practice1,360 citations
ASCENT: sacituzumab govitecan doubles survival in heavily pretreated metastatic triple-negative breast cancer
Sacituzumab govitecan is a standard second-line or later treatment for metastatic triple-negative breast cancer, roughly doubling survival compared with the chemotherapies it was tested against. Patients should expect neutropenia and diarrhoea, which are manageable with growth factor support and loperamide. Trials are now testing it earlier, in first-line combinations with pembrolizumab and after surgery for residual disease.
rctAnnals of Oncology 2021285 citations
Biomarker analyses in the phase III ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer
TROP2 IHC does not gate sacituzumab govitecan: the label requires no test, and the corpus records TROP2 as an expression readout without a threshold.
translationalNew England Journal of Medicine 2020changed practice1,496 citations
ZUMA-2: brexu-cel CAR-T for mantle cell lymphoma that has failed BTK inhibitors
ZUMA-2 gave patients with BTK-inhibitor-refractory mantle cell lymphoma, who previously had a median survival under a year, a therapy with durable remissions in a substantial fraction. Brexu-cel is now standard after BTK inhibitor failure and CAR-T is being tested earlier in the disease. Neurotoxicity rates are higher than in other lymphoma CAR-T trials.
translationalNew England Journal of Medicine 2017changed practice4,884 citations
ZUMA-1: axicabtagene ciloleucel for refractory large B-cell lymphoma, the first CAR-T approved for lymphoma
ZUMA-1 showed that CAR-T can cure a meaningful fraction of adults whose aggressive lymphoma no longer responds to chemotherapy, a group with a historical median survival of about six months (SCHOLAR-1). Axi-cel became the first CAR-T approved for lymphoma and later the first to beat standard second-line therapy in ZUMA-7. The comparatively high neurotoxicity of CD28-costimulated products was also first characterised here.
Similar pages
- TermCytokine release syndrome and ICANS: grading and management
Shares ZUMA-2, ZUMA-1, ZUMA-5, Brexucabtagene autoleucel.
- TreatmentZimberelimab
Shares A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies, Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Subst, Study With Various Immunotherapy Treatments in Participants With Lung Cancer, Study of Novel Treatment Combinations in Patients With Lung Cancer.
- TermICANS (neurotoxicity)
Shares Brexucabtagene autoleucel, ZUMA-2: brexu-cel CAR-T for mantle cell lymphoma that has failed BTK inhibitors, Axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trial, ZUMA-1: axicabtagene ciloleucel for refractory large B-cell lymphoma, the first CAR-T approved for lymphoma.
- TargetTROP2
Shares TROPiCS-02, Biomarker analyses in the phase III ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer, ASCENT, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET.
- IdeaTROP2 PET to choose and sequence TROP2 ADCs
Shares ASCENT-03, ASCENT-04 / KEYNOTE-D19, ASCENT, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET.
- TermThe CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting
Shares Brexucabtagene autoleucel, ZUMA-7, Autologous CAR-T manufacturing, batch by batch, Axicabtagene ciloleucel.
- PersonSattva S. Neelapu
Shares ZUMA-1, ZUMA-1: axicabtagene ciloleucel for refractory large B-cell lymphoma, the first CAR-T approved for lymphoma, ZUMA-7, Axicabtagene ciloleucel.
- PersonAditya Bardia
Shares Biomarker analyses in the phase III ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer, ASCENT, ASCENT: sacituzumab govitecan doubles survival in heavily pretreated metastatic triple-negative breast cancer, Sacituzumab govitecan.
cancers
fronts
technologies
targets
drugs
Phase 3CAR-T (BCMA, D-domain binder)
ApprovedCAR-T (CD19)
Axicabtagene ciloleucel · Yescarta
ApprovedAutologous CD19 CAR-T (CD28 costimulatory domain)
Brexucabtagene autoleucel · Tecartus
Phase 3monoclonal antibody
ApprovedSmall-molecule PI3Kδ inhibitor
Idelalisib · Zydelig
WithdrawnMonoclonal antibody (anti-CD47)
Phase 3not stated (registered as a drug or biological on ClinicalTrials.gov)
ApprovedADC
Sacituzumab govitecan · Trodelvy
companies
trials
A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract MalignanciesA Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple MyelomaA Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast CancerA Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast CancerASCENTASCENT-03ASCENT-04 / KEYNOTE-D19Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular LymphomaStudy of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal CancerStudy of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic LStudy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been TreatedStudy of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid LeukemiaStudy of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; SubstStudy of Novel Treatment Combinations in Patients With Lung CancerStudy of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid TumorsStudy of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)Study of Sacituzumab Govitecan in Chinese Patients With Metastatic Triple-negative Breast Cancer Who Received at Least Two Prior TreatmentsStudy of Sacituzumab Govitecan in Participants With Metastatic Solid TumorsStudy of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has SpreadStudy of Sacituzumab Govitecan in Patients With Solid TumorStudy of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung CancerStudy of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and ImStudy of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine TherapyStudy With Various Immunotherapy Treatments in Participants With Lung CancerTROPiCS-02Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung CancerZUMA-1ZUMA-2ZUMA-5ZUMA-7
roadmaps
Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruitingTriple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problemTROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET
ideas
key papers
ASCENT: sacituzumab govitecan doubles survival in heavily pretreated metastatic triple-negative breast cancerAxicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trialBiomarker analyses in the phase III ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancerZUMA-1: axicabtagene ciloleucel for refractory large B-cell lymphoma, the first CAR-T approved for lymphomaZUMA-2: brexu-cel CAR-T for mantle cell lymphoma that has failed BTK inhibitorsZUMA-7: axi-cel CAR-T instead of salvage chemotherapy and transplant for large B-cell lymphoma that relapses early