Johnson & Johnson and Eli Lilly Report Breakthrough Phase 3 Results for Novel Oncology Therapies

Johnson & Johnson's Dual-Antibody Combination Therapy Phase 3 Trial Impressive Results Published in The New England Journal of Medicine

Johnson & Johnson announced today that the combination of its B-cell maturation antigen (BCMA) and CD3-targeted bispecific antibody Tecvayli (teclistamab) with the anti-CD38 antibody Darzalex (daratumumab) significantly reduced the risk of disease progression or death in a Phase 3 clinical trial for relapsed or refractory multiple myeloma (RRMM). The Phase 3 MajesTEC-3 study enrolled 587 RRMM patients who had received 1 to 3 prior lines of therapy but still experienced disease progression, aiming to compare the efficacy of Tecvayli combined with Darzalex versus the current standard triplet regimens (DPd or DVd).The trial results were simultaneously published in The New England Journal of Medicine.

The analysis shows,During the nearly 3-year follow-up period, compared with the active control group, the risk of disease progression or death was reduced by 83.4% in the Tecvayli and Darzalex combination treatment group.（HR=0.17；95% CI：0.12-0.23；P<0.0001）。Among patients with no disease progression at the 6th month, over 90% (n=249) maintained no disease progression by the 3rd year.In terms of overall survival (OS), this combination therapy also demonstrated superiority, reducing the risk of death by 54% (HR=0.46; 95% CI: 0.32-0.65; P<0.0001). At the 3-year mark, the overall survival rate in the Tecvayli+Darzalex group reached 83.3%, significantly higher than 65.0% in the active control group. This combination has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of RRMM.

Lilly Announces Positive Results from Phase 3 Trial of Non-Covalent BTK Small Molecule Anticancer Drug

Eli Lilly and Company recently announced the results of the Phase 3 BRUIN CLL-314 clinical trial. The study compared the efficacy and safety of the non-covalent Bruton's tyrosine kinase (BTK) inhibitor Jaypirca (pirtobrutinib) with approved covalent BTK inhibitors in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The enrolled participants were either treatment-naive or had not previously received BTK inhibitor therapy.

The results showed that, in the intent-to-treat (ITT) population, pirtobrutinib achieved the primary endpoint of non-inferiority compared to the active control drug in terms of overall response rate (ORR), and was numerically superior.The ORR of patients in the pirtobrutinib group and the active control group were 87.0% (95% CI: 82.90-90.44) and 78.5% (95% CI: 73.73-82.85), respectively, with a statistically significant difference between the two groups (p<0.0001).Moreover, pirtobrutinib demonstrated higher ORR across all subgroups and showed a favorable trend in progression-free survival (PFS). In the ITT population, pirtobrutinib has exhibited a trend of reducing the risk of disease progression or death by 43%, while in the treatment-naïve subgroup with the longest follow-up, this risk reduction further increased to 76% (HR=0.239, 95% CI: 0.098-0.586).

Novartis Antibody Combination Therapy Phase 3 Trial Results Positive

Novartis today announced positive results from its VAYHIT2 Phase 3 clinical trial. The trial evaluated the efficacy of ianalumab in combination with the oral thrombopoietin receptor agonist Promacta (eltrombopag) in patients with primary immune thrombocytopenia (ITP) who had previously received corticosteroid treatment. The results showed,In terms of the primary endpoint, time to treatment failure (TTF), ianalumab (9 mg/kg) combined with eltrombopag extended ITP disease control by 45%., that is, the time for patients to maintain a safe platelet level during treatment and after discontinuation of the drug was significantly prolonged. Compared with the placebo combined with eltrombopag treatment, the median TTF in the ianalumab combination therapy group was extended to 2.8 times (13.0 months vs 4.7 months), suggesting that this regimen has significant advantages in disease control.

Further data shows,Sixty-two percent of patients receiving ianalumab in combination with eltrombopag achieved sustained platelet response at 6 months., while the proportion in the placebo combined with eltrombopag group was 39%. Novartis plans to submit the data from the Phase II ITP trial VAYHIT2 along with the results from the ongoing Phase I ITP trial VAYHIT1 to regulatory authorities in 2027, to promote further review and potential approval of this regimen.

Ianalumab is an antibody therapy that blocks the BAFF receptor. While blocking BAFF signaling, it can deplete B cells through enhanced antibody-dependent cellular cytotoxicity (ADCC)., has the potential to bring about more lasting disease relief.Ianalumab in ITP treatment with a regimen of once monthly for four consecutive doses, which is expected to achieve long-term disease control through short-course treatment. Currently, the drug is also being studied for other B-cell-driven autoimmune diseases, including ongoing Phase 3 clinical trials for frontline ITP and relapsed/refractory warm antibody-type autoimmune hemolytic anemia.

References:

[1] Novartis ianalumab significantly extends disease control in patients with immune thrombocytopenia with only four once-monthly doses. Retrieved December 9, 2025 from https://www.globenewswire.com/news-release/2025/12/09/3202247/0/en/Novartis-ianalumab-significantly-extends-disease-control-in-patients-with-immune-thrombocytopenia-with-only-four-once-monthly-doses.html

[2] Unprecedented results from the Phase 3 MajesTEC-3 study support TECVAYLI®▼ (teclistamab) plus DARZALEX® (daratumumab) subcutaneous formulation as a potential standard of care as early as second line for patients with relapsed/refractory multiple myeloma. Retrieved December 9, 2025 from https://www.globenewswire.com/news-release/2025/12/09/3202484/0/en/Unprecedented-results-from-the-Phase-3-MajesTEC-3-study-support-TECVAYLI-teclistamab-plus-DARZALEX-daratumumab-subcutaneous-formulation-as-a-potential-standard-of-care-as-early-as-.html

[3] Lilly's Jaypirca (pirtobrutinib) met its primary endpoint in first-of-its-kind, head-to-head Phase 3 study versus Imbruvica (ibrutinib). Retrieved December 9, 2025 from https://investor.lilly.com/news-releases/news-release-details/lillys-jaypirca-pirtobrutinib-met-its-primary-endpoint-first-its

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