Janssen debuts promising new cancer data at ASCO

Janssen took the opportunity at the American Society of Clinical Oncology (ASCO) annual event to present promising new Phase 2 and 3 data on two of its candidates: erdafitinib in metastatic urothelial cancer, and Imbruvica (ibrutinib) combined with rituximab in the treatment of Waldenström’s Macroglobulinemia, a rare and incurable form of non-Hodgkin’s lymphoma, in relapsed/refractory or treatment-naïve patients.

Phase 3 Data from a pre-planned interim analysis of Imbruvica and rituximab showed that the drug met its primary endpoint of clinically and statistically improved progression-free survival (PFS), reducing the risk of disease progression or death by 82% compared to placebo and rituximab after 30 months of treatment. All secondary endpoints, including response rate, timte to next treatment, rate of sustained haemoglobin improvement and number of participants with adverse events, supported the primary endpoint. The Imbruvica combo also showed greater overall response and major response rates, with 92% and 72% compared to 47% and 32%.

"These important data demonstrate ibrutinib plus rituximab resulted in marked improvement in progression-free survival across all lines of therapy in Waldenström’s macroglobulinemia regardless of patient subtypes, compared to placebo plus rituximab," commented Dr Meletios A Dimopoulos, Professor and Chairman of the Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine in Athens, Greece, and lead study investigator. "Not only was there marked statistical and clinical difference in the efficacy compared to rituximab monotherapy, but the combination of ibrutinib and rituximab did not result in any unanticipated safety signals."

The second candidate, once-daily pan-FGFR inhibitor erdafitinib, demonstrated an overall response rate of 40% in its 99 trial participants with a median PFS rate of 5.5 months and a median overall survival rate of 13.8 months. The findings bode well for Janssen’s future efforts in a disease subtype which affects 90% of the 124,000 annual cases of bladder cancer in Western Europe.

"These study results are very promising, particularly as this is an area of high unmet need with patients who otherwise have very limited treatment options remaining. We hope that the response rates shown by erdafitinib could eventually give patients with metastatic or surgically unresectable urothelial cancer a new treatment option," remarked Dr Ivo Winiger-Candolfi, EMEA Oncology Therapeutic Area Lead at Janssen. "The successful development of new oncology therapies, such as erdafitinib, is an example of our precision medicine approach: providing the right patient, with the right treatment, at the right time. We recognise that every patient is unique and that by accounting for individual differences in people’s genes, environments and lifestyles, we can optimise the therapeutic benefit for particular groups of patients. We look forward to understanding the potential efficacy and broader safety profile of erdafitinib in both Phase 3 development as well as in combination with anti-PD1 therapy."

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