Johnson & Johnson's Two Innovative Bispecific Antibodies Approved in China for Multiple Myeloma and NSCLC

Feb 11, 2025 13:44 CST Updated 13:44

Johnson & Johnson

Medical Device R&D and Manufacturer

On February 11, Johnson & Johnson's 2 innovative bispecific antibodies were approved for marketing in China:「Taqiutumab」Monotherapy for patients who have received at least three prior treatments(Including a proteasome inhibitor, an immunomodulator, and an anti-CD38 antibody)Relapsed or Refractory Multiple Myeloma（R/R MM）Adults sufferPatient；"Amivantamab"First-line treatment for patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 20 insertion mutations.

Tarquetumab: The World's FirstCD3 × GPRC5D Bispecific Antibody

Screenshot source: Johnson & Johnson Official WeChat

Taqiutumab（Talquetamab）It is a T-cell engaging bispecific antibody targeting CD3 × GPRC5D, co-developed by Genmab and Johnson & Johnson.In August 2023, the FDA granted accelerated approval to talquetamab for the treatment of adult patients with R/R MM who have received at least four prior lines of therapy, marketed under the brand name Talvey. In the same month, the drug was also approved for marketing in the EU.

The overseas approval of Talquetamab is based on the results of the MonumenTAL-1 clinical trial.MonumenTAL-1 is a single-arm, open-label, multi-cohort, multi-center, dose-escalation Phase I/II clinical trial.(Phase I Registration Number:NCT03399799; Phase II Registration Number:NCT04634552）, including more than 300 patients.

In the Phase II study, enrolled patients had received ≥ 3 prior lines of therapy, including ≥ 1 proteasome inhibitor, ≥ 1 immunomodulatory drug, and ≥ 1 CD38 antibody.

Long-term efficacy and safety results presented at the 2024 EHA:

0.4 mg/kg Once WeeklyTime（QW）Cohort（n=143）ORR was 74.1%, CR rate was 32.9%，mDoR is 9.5 months（95%CI，6.7-13.4），mPFS was 7.5 months（95%CI，5.7-9.4）；
0.8 mg/kg Twice Weekly（Q2W）Cohort（n=154）ORR was 69.5%, CR rate was 40.3%, and mDoR was 17.5 months.（95%CI，12.5-NR），mPFS was 11.2 months（95%CI，8.4-14.6）。

MonumenTAL-1 Clinical Trial Results

Screenshot source: Insight Database Web Version

In China, Taqueptinumab was submitted for marketing authorization for the first time on February 8, 2024, and has been included in the priority review.

According to the Insight database, the drug currently has 3 Phase III clinical trials ongoing in China:

Registered in June 2022MonumenTAL-3Exploring the combination of Talquetamab and Daratumumab subcutaneous formulation（SC）And Pomalidomide（Tal-DP）、Talquetamab Combined with Daratumumab SC（Tal-D）、Daratumumab SC in combination with Pomalidomide and Dexamethasone（DPd）Three therapies are used for relapsed/refractory multiple myeloma patients in second-line and beyond treatment;
Registered in July 2022MajesTEC-7Exploring the Combination of CD3/BCMA Bispecific Antibody Teclistamab with Daratumumab + Lenalidomide（Tec-DR）CD3/GPRC5D Bispecific Antibody Talquetamab Combined with Daratumumab + Lenalidomide（Tal-DR）First-line treatment for newly diagnosed multiple myeloma patients;
Registered in December 2023 MonumenTAL-6, aimed to compare the combination of Tarquetimab and Pomalidomide（Tal-P）、Tarquetumab in combination with Telitacimab（Tal-Tec）, Elotuzumab + Pomalidomide + Dexamethasone Selected by the Researcher（EPd）Or Pomalidomide + Bortezomib + Dexamethasone（PVd）Treatment of relapsed or refractory multiple myeloma in patients who have received at least two prior lines of therapy.

Multiple myeloma has been a traditional area of strength for Johnson & Johnson over the years.Comprehensive layout of small-molecule drugs, monoclonal antibodies, bispecific antibodies, and CAR-T, covering different lines of therapy, different patient populations, and multiple technological approaches working in synergy.

CD38 monoclonal antibody approved in 2015DaratumumabIn 2023, global annual sales have reached $9.744 billion, still maintaining a high growth rate, and it is expected to enter the billion-dollar club in 2024; the BCMA CAR-T introduced from Legend Biotech.Cilta-celHas also become one of the best-performing CAR-T products in the market, with steady growth expected to break the $1 billion mark; the layout ofTwo bispecific antibody productsSuch as targeting CD3/BCMATelituximab, Targeting CD3/GPRC5DTaqiutumab, and is now gradually rolling out in major markets worldwide.

From the perspective of the CD3/GPRC5D bispecific antibody,According to the Insight database, currently, apart from TarquetumabOnly 4 active projects globally have entered the clinical stage., and all are in the early clinical stage, with the highest progress only at Phase I/II clinical trials. Talquetamab is clearly far ahead. The four research projects of similar bispecific antibodies are all from companies in China, respectively fromV立志博, 正大天晴, 齐鲁制药, 康诺亚。

Compared to bispecific antibodies, trispecific antibody drugs are even more promising newcomers.Tian Guangshi, Innovent Biologics, Simcere PharmaceuticalHas already started the layout of CD3/BCMA/GPRC5D in sync with Johnson & Johnson.Three AntibioticsDrug, SIM0500 from Sinopharm has gained the favor of MNCs and reached an agreement with AbbVie on January 13, 2025, for the highest10.55 Billion US dollarsCooperation.

Amivantamab: The World's FirstEGFR/cMET Bispecific Antibody

Screenshot source: Official WeChat account of the company

Amivantamab isThe world's first and only approved EGFR/cMET bispecific antibody. Based on Phase I study in May 2021（CHRYSALIS）Positive ResultsGranted FDA Accelerated Approval, for the treatment of locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations that have progressed after platinum-based chemotherapy.(NSCLC) Adult patients.

In March 2024, the FDA hadFull approval of the indication, and approved amivantamab in combination with carboplatin and pemetrexed for the first-line treatment of patients with locally advanced or metastatic NSCLC carrying EGFR exon 20 insertion mutations.

2023 European Lung Cancer Congress（ELCC）At the conference, Johnson & Johnson announced positive results regarding the long-term efficacy and safety of amivantamab monotherapy in patients with advanced NSCLC harboring EGFR exon 20 insertion mutations whose disease had progressed after platinum-based chemotherapy.

The study enrolled a total of 114 patients.Median follow-up of 19.2 months, 48 patients (42%) Patient Survival. Investigator-assessedORR was 37%，Median DoR was 12.5 months，Median PFS was 6.9 months ，Median OS was 23 months。

In different subgroups, alsoClinical efficacy was observed in all cases:

In the elderly,Age ≥ 65 years and ≥ 75 yearsORR were 32% and 33%, respectively.；
In patients who have undergone extensive treatment,>2 prior treatmentsORR was 53%, Previous ImmunotherapyORR is 42%, previous EGFR TKI therapyORR was 52%；
In patients who were previously sensitive or resistant to platinum-based chemotherapy,ORR were 36% and 31%, respectively.。

In terms of safety, no new safety signals were found, rash(All levels, 89%)Infusion-related reactions（67%）It remains the most common toxicity.

Insight database shows,Besides AmivantamabIn addition, currentlyGlobally, 11 bispecific antibody drugs targeting EGFR/cMET are still in active status., the fastest progressing research isPumisHS-20117 has entered Phase III clinical trials.

BesidesHS-20117. In addition, there are7 ItemsChinese-produced New Drug Under Research：

There are 2 products in clinical Phase I/II, respectively.HengruiSHR-9839 andShoreStepEMB-01;
One has been approved for clinical use, which isHengruiSHR-9839Subcutaneous Formulations；
Four products are still in the preclinical stage, respectively belonging toKangyuan Bochuang, Dongcheng Pharmaceutical, Fuhong Hanlin, and Junshi。

Screenshot source: Insight database (Statistics as of: February 6, 2025)

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