Johnson & Johnson Unveils First-in-Class KLK2/CD3 Bispecific and BCMA/GPRC5D/CD3 Trispecific Antibody Data at ASCO 2025

At the 2025 ASCO Annual Meeting, Johnson & Johnson presented new data on its portfolio and pipeline of hematologic malignancies and solid tumor products, including 5 oral presentations, 2 rapid oral presentations, and 7 posters.

This article will select some for specific introduction, for readers' reference.*Due toWenDue to limited space, it is difficult to include all important research results. Welcome to use the Insight database for reference (press and hold the QR code at the end of the article).Free TrialOh~).

Product: JNJ-78278343

Molecular Mechanism: KLK2/CD3 Bispecific Antibody

Registration Number: NCT04898634

Presentation Type: Rapid Oral Report

Abstract No.: 5017

As of October 7, 2024, 174 patients were enrolled and received ≥1 dose of JNJ-78278343 treatment. The median number of prior treatment lines was 4.(99.4% received androgen receptor pathway inhibitors, 78.2% received taxane chemotherapy, 17.2% received lutetium [177Lu]-texiveptide)。

In the RP2D efficacy population(n=33; 3.5 mg [Day 1], 18 mg [Day 8], 300 mg Q6W IV)，PSA50 Response(PSA levels decreased by at least 50%)For 42.4%，Median rPFS was 6.77 months（95% CI 2.89, NE）, of which 39.4% of patients are still under treatment.

Among 85 patients with measurable lesions, lymph node metastasis(+/- Bone Metastasis)Patient'sORR was 16.1% (n=5/31), Patients with visceral metastasesORR is 3.7% (n=2/54)，Median DOR was 11.27 months（95% CI 3.58, NE）。

In terms of safety, there were no JNJ-78278343-related deaths. One patient experienced dose-limiting endocrinopathy, specifically transient Gr 3 ALT/AST elevation, after receiving a 50 mg dose escalation subcutaneous injection. Although the majority of patients reported ≥1 TRAE.(Overall 82.2%; Intravenous injection 68.1%; Subcutaneous injection 92.2%), but most of these TRAEs were low-grade, with only 9.2% of patients(Intravenous injection 6.9%; Subcutaneous injection 10.8%)≥3 Grade TRAE occurred.

Screenshot source: Insight database

The researchers concluded that JNJ-78278343 was extremely well-tolerated and demonstrated favorable anti-tumor activity, providing proof of concept that KLK2 can serve as a T-cell redirecting target. These results are clinically significant for mCRPC.Phase III clinical trials are in the planning stage.。

Product: JNJ-79635322

Molecular Mechanism: BCMA/CD3/GPRC5D Trispecific Antibody

Registration Number: NCT05652335

Presentation Type: Oral Report

Abstract No.: 7506

As of2025 Year1 Month15 Day,126 Example: Patients receivedJNJ-79635322 Treatment（36 Example Acceptance100 mg，Q4W）, the median follow-up time was8.2 months. In patients with evaluable efficacy,RP2D Dose Group（n=36）ORR For86%（75% ≥Very Good Partial RemissionVGPR），Overall（n=124）ORR For73%（66%≥VGPR）。

Among them, in those who have not received anti-BCMA/GPRC5D Among the treated patients,RP2D Dose Group（n=27） ORR Achieve100%（89%≥VGPR），And all patients continued to experience relief.(Median follow-up8.5 Months)The median time to first remission was 1.2 months.

In terms of safety,99% The patient experienced ≥1 NextAE, the most common including cytokine release syndrome（CRS，59%；None ≥3 Level), Nail-relatedAE（1/2 Level56%）, Abnormal taste（1/2 Level56%）、Neutropenia（48%；3/4 Level41%）And non-rash skinAE（47%；3/4 Level1%）。16% of patientsWeight loss occurs(No ≥3 Level)，16% Rash appears(No ≥3 Level)，2% OccurrenceICANS(All are1 Level)，75% Infection Occurs（3/4 Level28%）。5 NamesThe patient experienced dose-limiting toxicity,4 NamesDue toAE Death.

Registration Number: NCT04181827

Presentation Type: Poster

Abstract No.: 7539

In addition to the aforementioned drugs, if you wish to learn more clinical data from Johnson & Johnson at this year’s ASCO conference, you can scan the QR code at the end of the article and visit the "Clinical Trial Results" module in the Insight database for inquiries.