Johnson & Johnson

Biomarkers

• EGFR exon 19 deletion / L858R7
• EGFR exon 20 insertion4
• NPM1 mutation3
• MET exon 14 skipping1

Drugs in these trials

Targeted, immune and antibody-drug-conjugate therapies named in the company's active biomarker-selected trials (including other companies' drugs used in combination).

amivantamab 11lazertinib 9erdafitinib 6bleximenib 3venetoclax 2osimertinib 1pembrolizumab 1

Upcoming readouts

Active phase 2 and 3 trials whose primary completion date falls in the next 12 months, according to the sponsor.

• 2027-01 A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer Phase 1/2 · EGFR exon 19 deletion / L858R
• 2027-02 A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1) Phase 1/2 · NPM1 mutation
• 2027-05 Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib Phase 2 · EGFR exon 19 deletion / L858R
• 2027-08 A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer Phase 2 · EGFR exon 19 deletion / L858R, EGFR exon 20 insertion

Trials

20 of 28 trials shown

1. A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

   Recruiting Phase 3 Johnson & Johnson Started 2025Primary completion 2029-06 NCT06852222

   bleximenibvenetoclaxazacitidine

   …d lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (\> or =) 10% bone marrow bla…

   NPM1 mutationLeukemia, Myeloid, Acute

2. A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

   Recruiting Phase 3 Johnson & Johnson Started 2025Primary completion 2028-04 NCT06919965

   erdafitinib FDA EUMitomycin Cgemcitabine

   Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue) as determin…

   FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementNon-Muscle Invasive Bladder Neoplasms

3. A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

   Recruiting Phase 3 Johnson & Johnson Started 2024Primary completion 2028-06 NCT06319820

   erdafitinib FDA EUgemcitabineMMC

   Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determi…

   FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementNon-Muscle Invasive Bladder Neoplasms

4. A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

   Active, not recruiting Phase 3 Johnson & Johnson Started 2022Primary completion 2024-01 NCT05388669

   lazertinib FDA EUamivantamab FDA EU

   …cell lung cancer (NSCLC), characterized by either epidermal growth factor receptor (EGFR) Exon 19 deletion (Exon 19del) or Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) mutation by …

   EGFR exon 19 deletion / L858RAdvanced or Metastatic Non-small Cell Lung Cancer

5. A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

   Active, not recruiting Phase 3 Johnson & Johnson Started 2021Primary completion 2023-07 NCT04988295

   lazertinib FDA EUamivantamab FDA EUpemetrexedcarboplatin

   …dvanced or metastatic disease diagnosis by either epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R mutation

   EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung

6. A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

   Active, not recruiting Phase 3 Johnson & Johnson Started 2020Primary completion 2023-08 NCT04487080

   amivantamab FDA EUosimertinib FDA EUlazertinib FDA EU

   The tumor harbors exon 19 deletions (Exon 19del) or Exon 21 L858R substitution, as detected by an food and drug administrati…

   EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung

7. A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

   Active, not recruiting Phase 3 Johnson & Johnson Started 2020Primary completion 2023-05 NCT04538664

   amivantamab FDA EUpemetrexedcarboplatin

   … cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation

   EGFR exon 20 insertionCarcinoma, Non-Small-Cell Lung

8. A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

   Active, not recruiting Phase 3 Johnson & Johnson Started 2018Primary completion 2024-04 NCT03390504

   erdafitinib FDA EUVinfluninedocetaxelpembrolizumab

   …ticipants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

   FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementUrothelial Cancer

9. A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

   Recruiting Phase 2 Johnson & Johnson Started 2024Primary completion 2029-05 NCT06667076

   amivantamab FDA EUlazertinib FDA EUpemetrexedcarboplatin

   …Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

   EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung

10. Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib

    Active, not recruiting Phase 2 Johnson & Johnson Started 2024Primary completion 2027-05 NCT06120140

    amivantamab FDA EUlazertinib FDA EUDoxycyclineMinocyclineClindamycinChlorhexidineZinc gluconatePropranololTimololClobetasol

    Have a tumor that harbors an epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution, as detected by an Food and Drug Administration (FDA)-appro…

    EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung

11. A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer

    Active, not recruiting Phase 1/2 Johnson & Johnson Started 2023Primary completion 2027-01 NCT05908734

    Cetrelimabamivantamab FDA EU

    Cohort A: Participant's tumor must have an EGFR exon19del or L858R mutation, as determined by local molecular testing, Cohort B: Participants must …

    EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung

12. Premedication to Reduce Amivantamab Associated Infusion Related Reactions

    Active, not recruiting Phase 2 Johnson & Johnson Started 2023Primary completion 2024-03 NCT05663866

    dexamethasoneMontelukastmethotrexateamivantamab FDA EUlazertinib FDA EU

    Previously identified EGFR-mutated non-small cell lung cancer (NSCLC) (EGFR Exon19 deletion or L858R) (identified locally in a Clinical Laboratory Improvement Amendments \[CLIA\]-ce…

    EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung

13. A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

    Recruiting Phase 2 Johnson & Johnson Started 2022Primary completion 2027-08 NCT05498428

    amivantamab FDA EUlazertinib FDA EUcarboplatinpemetrexedDirect Oral Anticoagulant (DOAC)Low Molecular Weight Heparin (LMWH)

    …quirements include: Cohorts 1, 3, 3b, 5, 6 and 7: epidermal growth factor receptor (EGFR) exon 19 deletion (Exon19del) or Exon 21 L858R mutation

    EGFR exon 19 deletion / L858REGFR exon 20 insertionCarcinoma, Non-small-Cell Lung

14. Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

    Active, not recruiting Phase 1/2 Johnson & Johnson Started 2022Primary completion 2028-03 NCT05316155

    erdafitinib FDA EU

    For selected Cohorts: Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, approved by the sponsor prior to th…

    FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementNon-Muscle Invasive Bladder Neoplasms

15. A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)

    Recruiting Phase 1/2 Johnson & Johnson Started 2021Primary completion 2027-02 NCT04811560

    bleximenib

    AML harboring KMT2A-r (gene rearrangement/translocation) or NPM1 mutations only

    NPM1 mutationAcute Leukemia

16. An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer

    Active, not recruiting Phase 2 Johnson & Johnson Started 2015Primary completion 2022-09 NCT02365597

    erdafitinib FDA EUmidazolammetformin

    …NJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic Alterations

    FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementUrothelial Cancer

17. A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer

    Active, not recruiting Phase 1 Johnson & Johnson Started 2023Primary completion 2025-03 NCT05567185

    erdafitinib FDA EU

    At least 1 of the study protocol defined activating fibroblast growth factor receptors (FGFR) mutation or fusion, as determined by local or central testing using either tumor tissue or urine s…

    FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementUrinary Bladder Neoplasms, Receptors, Fibroblast Growth Factor

18. A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies

    Active, not recruiting Phase 1 Johnson & Johnson Started 2022Primary completion 2026-10 NCT05453903

    bleximenibvenetoclaxazacitidinecytarabinedaunorubicinidarubicin

    c) harboring KMT2A, NPM1, NUP98, or NUP214 alterations

    NPM1 mutationLeukemia, Myeloid, Acute

19. A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer

    Active, not recruiting Phase 1 Johnson & Johnson Started 2019Primary completion 2027-02 NCT04077463

    lazertinib FDA EUamivantamab FDA EUcarboplatinpemetrexed

    …Cohort D, E, and F: Participant must have advanced or metastatic EGFR-mutated NSCLC (EGFR Exon19 deletion or L858R) that has progressed on prior treatment with osimertinib in the first or second …

    EGFR exon 19 deletion / L858REGFR exon 20 insertionCarcinoma, Non-Small-Cell Lung

20. Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

    Active, not recruiting Phase 1 Johnson & Johnson Started 2016Primary completion 2026-12 NCT02609776

    amivantamab FDA EUlazertinib FDA EUcarboplatinpemetrexed

    …ion Dose Escalation with lazertinib only: Participants must have been diagnosed with EGFR Exon 19del or L858R activating mutation and (a) be treatment naïve for metastatic disease, without a…

    EGFR exon 19 deletion / L858REGFR exon 20 insertionMET exon 14 skippingNon-Small-Cell Lung Cancer

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