Janssen updates ASCO 2023 on oncology pipeline

Laboratory research

Janssen has presented new data from across its oncology pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

Talquetamab

Talquetamab is an investigational GPRC5D-directed bispecific antibody currently in clinical development.

Updated results from the Phase II MonumenTAL-1 study show that with a median of 13-19 months of follow-up, talquetamab continues to deliver durable responses in patients with relapsed and refractory multiple myeloma (RRMM), including in patients with prior T cell redirection therapy.

Talquetamab demonstrated overall response rates (ORR) of more than 70% across weekly and biweekly T-cell redirection naïve dosing cohorts and 65% in patients with prior T cell redirection therapy.

Based on these data, talquetamab is currently being reviewed under accelerated assessment by the European Medicines Agency (EMA).

Janssen has also revealed updated data from the Phase II TRIMM-2 study, which show that the ORR for a combination of talquetamab with Darzalex (daratumumab) was 71.4% and 84.0% in the two dosing cohorts – weekly and biweekly, respectively.

Tecvayli (teclistamab)

The first results were shared from the RedirecTT-1 study with teclistamab and talquetamab simultaneously targeting BCMA and GPRC5D in patients with RRMM.

Findings showed a 96% ORR with biweekly teclistamab plus talquetamab in eligible patients, competitive with the results for CAR-T cell therapies in this patient population.

Rybrevant (amivantamab) and lazertinib

New long-term data from the treatment-naïve cohort of the CHRYSALIS study showed the combination of amivantamab and lazertinib, as a first-line treatment in patients with common epidermal growth factor receptor (EGFR)*-mutated non-small cell lung cancer (NSCLC), was associated with sustained anti-tumour activity.

At a median follow-up of 33.6 months, 50% of patients remain progression free and on treatment.

Results from the CHRYSALIS-2 study show that MET positivity by immunohistochemistry (IHC) may be a predictive biomarker which can identify the patients most likely to benefit from amivantamab and lazertinib.

Erdafitinib

Erdafitinib is an oral pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor being evaluated for the treatment of advanced urothelial cancer (UC).

The interim analysis from Cohort 1 of the Phase III THOR study evaluated erafitinib versus chemotherapy in patients with metastatic or unresectable UC and select FGFR gene alterations (FGFRalt) who had received prior treatment with an anti-programmed death ligand 1 (PD-(L)1) monoclonal antibody.

In THOR, erdafitinib significantly extended overall survival (OS) (median OS of 12.1 months compared to 7.8 months in patients who received chemotherapy).

Treatment with erdafitinib also provided significantly longer progression free survival (PFS) and greater overall response rate (ORR) versus chemotherapy.

Data was also presented on the Phase II NORSE study, evaluating erdafitinib and cetrelimab combination therapy, and the Phase II RAGNAR study evaluating the efficacy and safety of erdafitinib.

Cilta-Cel

Cilta-cel is a dual-binding, BCMA-directed, genetically modified autologous T cell immunotherapy.

CARTITUDE-4 is an international, randomised, open-label Phase III study evaluating the efficacy and safety of cilta-cel versus standards of care (SOC), such as pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in adult patients with relapsed and refractory multiple myeloma, who have received one to three prior lines of therapy and are lenalidomide-refractory (RRMM).

At 16 months median follow-up with an ORR of 85% versus 67% for SOC treatments, a single infusion of cilta-cel significantly prolonged PFS compared to SOC, reducing risk of disease progression or death by 74% in earlier-line multiple myeloma treatment.

CARTITUDE-1 is a Phase Ib/II, open-label, multi-centre study evaluating cilta-cel for the treatment of patients with RRMM, who previously received a PI, an IMiD and an anti-CD38 monoclonal antibody, and who had disease progression on or after the last regimen.

In the final analysis of the study, at a median follow-up of nearly three years, an estimated 62.9% of patients were alive. In contrast, heavily pre-treated patients with RRMM who are treated with SOC therapy have a median OS of approximately 9-12 months.

Janssen submitted a Type II variation application to the European Medicines Agency (EMA) in May 2023, seeking approval of cilta-cel for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma in earlier lines of treatment.

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