JOHNSON & JOHNSON Preliminary findings suggest robust clinical activity and depth of response in patients treated with BALVERSA in combination with cetrelimab.1 The overall safety of treatment with BALVERSA in combination with cetrelimab was generally consistent with BALVERSA monotherapy and aligned with the known safety profile of approved anti-PD-1 therapies.1 At the time of analysis, the investigator-assessed objective response rate (ORR) in 19 patients treated with BALVERSA in combination with cetrelimab was 68 percent (95 percent confidence interval [CI]; 43-87), of which 21 percent (n=4) were complete responses (CR) and 47 percent were partial responses (PR).1 The disease control rate (DCR) was 90 percent (95 percent CI; 67-99) for evaluable patients using the Response Evaluation Criteria in Solid Tumors Version 1.1* (RECIST v1.1) criteria.1 The ORR in 18 patients treated with BALVERSA monotherapy was 33 percent (95 percent CI; 13-59), in which one patient showed a CR and 28 percent (n=5) were partial responses. The DCR was 100 percent (95 percent CI; 82-100).1
'PD-1 inhibitors have become treatment options for many types of solid tumors, including bladder cancer. Now, as we learn more about the genetic factors that impact treatment outcomes, we are exploring new treatment approaches that may help patients with specific mutations, including FGFR-alterations and fusions,' said
Fibroblast growth factor receptors are a family of receptor tyrosine kinases that can be activated by genetic alterations in a variety of tumor types, potentially leading to increased tumor cell growth and survival.2 Approximately 20 percent of patients diagnosed with mUC have an FGFR genetic alteration.3,4 A current standard of care for mUC is cisplatin-based chemotherapy, however, more than 50 percent of patients with mUC may be ineligible for cisplatin treatment, underscoring a need for new treatment options.5 Alternative options for patients with newly diagnosed mUC include different chemotherapy regimens or PD-1 inhibitors, which enhance T-cell immune responses against the tumor cells.6
The findings presented at ESMO build upon the growing set of BALVERSA data. In 2019 the
The safety profile of BALVERSA in combination with cetrelimab (n=24) was generally similar to that of BALVERSA monotherapy (n=24), with the most common treatment-emergent adverse events (AEs) being hyperphosphatemia (BALVERSA in combination with cetrelimab vs BALVERSA monotherapy, 58 percent vs 58 percent), stomatitis (54 percent vs 63 percent), diarrhea (42 percent vs 50 percent), dry mouth (58 percent vs 21 percent), dry skin (38 percent vs 21 percent) and anemia (25 percent vs 25 percent).1 Grade 3-4 AEs occurred in 12 patients (50 percent) in the BALVERSA in combination with cetrelimab arm and 9 patients (38 percent) in the BALVERSA arm.1 In the BALVERSA in combination with cetrelimab arm, the most frequent Grade 3-4 AEs were stomatitis (n=3 [12.5 percent]), lipase increased (n=3 [12.5 percent]), and fatigue (n=2 [8.3 percent]); in the BALVERSA arm, these were anemia (n=3 patients [12.5 percent]) and general physical health deterioration (n=3 [12.5 percent]).1
'As the first targeted treatment approved for patients with locally advanced or metastatic bladder cancer and FGFR3 or FGFR2 genetic alterations after platinum-based chemotherapy, we are encouraged by the data that continue to support the safety and efficacy of BALVERSA and its benefit for these patients with high unmet medical need. By investigating two active classes of drugs with BALVERSA and cetrelimab, our aim is to maximize the potential benefits of this combination approach for these patients,' said
RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumors respond to treatment and is based on whether tumors shrink, remain the same or increase in size.8
About the NORSE Study9
NORSE (NCT03473743) is an open-label, Phase 1b/2 multicenter study of BALVERSA in combination with cetrelimab in patients with locally advanced or metastatic urothelial cancer and FGFR3 or FGFR2 gene alterations. Participants enrolled in Phase 1b may have received any number of lines of prior therapy, and participants enrolled in Phase 2 had no prior systemic therapy for metastatic disease and are ineligible for cisplatin-based chemotherapy, currently the standard of care. Phase 1b established the recommended Phase 2 dose (RP2D) for BALVERSA in combination with cetrelimab, and Phase 2 evaluates the safety and efficacy of the RP2D. The study is being conducted in three phases: screening phase, treatment phase and follow-up phase. Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers and safety. Enrollment of the Phase 2 part of the NORSE study is currently ongoing.
About Urothelial Carcinoma
Urothelial carcinoma, also known as transitional cell carcinoma, starts in the innermost lining of the bladder.10 It is the most common and frequent form of bladder cancer, representing more than 90 percent of all bladder cancers.11 Approximately one in five patients (20 percent) diagnosed with mUC have an FGFR genetic alteration.4,5 Fibroblast growth factor receptors are a family of receptor tyrosine kinases that can be activated by genetic alterations in a variety of tumor types, and these alterations may lead to increased tumor cell growth and survival.3 In the
About BALVERSA
BALVERSA (erdafitinib) is a once-daily, oral FGFR kinase inhibitor that is approved by the
BALVERSA is being studied in multiple clinical trials including the Phase 3 THOR (NCT03390504) study evaluating BALVERSA versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations with disease progression following one prior line of therapy; the Phase 2 THOR-2/BLC2003 study (NCT04172675) study examining BALVERSA versus investigator choice of intravesical chemotherapy in participants who received Bacillus Calmette-Guerin and recurred with high risk non-muscle-invasive bladder cancer; and the Phase 2 RAGNAR (NCT04083976) study assessing BALVERSA in patients with advanced solid tumors and FGFR genetic alterations.16,17,18
In 2008, Janssen entered into an exclusive worldwide license and collaboration agreement with
For more information, visit www.BALVERSA.com.
About Cetrelimab
Cetrelimab is a Janssen discovered and developed investigational programmed cell death receptor-1 (PD-1) monoclonal antibody being studied in the treatment of bladder cancer, prostate cancer, and multiple myeloma as a combination treatment. Cetrelimab is also being evaluated in multiple combination regimens across the Janssen oncology portfolio.
About the Janssen Pharmaceutical Companies of
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of
Cautions Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of BALVERSA (erdafitinib) and cetrelimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of
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