Strong cancer trial data for Janssen at ASH 2015
pharmafile | December 8, 2015 | News story | Research and Development | Cancer, Janssen, darzalex, imbruvica, oncology
Janssen presented new cancer trial data at the 57th Annual American Society of Haematology (ASH) meeting Orlando, Florida – with study results for Darzalex (daratumumab) proving a highlight.
New daratumumab data
New data from the ongoing Phase I/III GEN503 investigational study showed daratumumab, in combination with Celgene’s Revlimid (lenalidomide) and dexamethasone, yielded an overall response rate (ORR) of 81% in relapsed or refractory multiple myeloma patients who had received two prior therapies. Overall survival (OS) rate at 18 months was 90%, with 72% of patients experiencing progression-free survival (PFS).
The GEN503 study enrolled 32 patients who had received a median of two prior treatments. Stringent complete response was reported in eight patients, while complete response was reported in three, very good partial response was reported in nine, and partial response was reported in six.
Janssen is co-developing daratumumab with Genmab, which originally developed the compound.
Imbruvica
The J&J pharmaceutical subsidiary also had good news to report for Imbruvica (ibrutinib), which it co-develops with AbbVie’s Pharmacyclics.
Data from the Phase III RESONATE-2 trial showed Imbruvica was superior to GSK’s Leukeran (chlorambucil) in all efficacy endpoints measured in patients with treatment-naive chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) aged 65 or older. At 24 months, Imbruvica achieved a 98% OS rate, versus 85% for Leukeran.
Additionally, Imbruvica was associated with a significantly higher overall response rate, at 86% versus Leukeran’s 35%; and significantly increased the rate of sustained improvements in both haemoglobin and platelets.
Mantle cell lymphoma
Imbruvica also performed well in treating the aggressive blood cancer mantle cell lymphoma (MCL). In the Phase III RAY trial, it was shown to significantly improve progression-free survival versus Pfizer’s intravenous Torisel (temsirolimus). Imbruvica was associated with a 57% reduction in the risk of disease progression or death with a median follow-up of 20 months.
The median PFS for the 139 patients in RAY who received Imbruvica was 14.6 months, compared with 6.2 months for the 141 who received Torisel. At two years, patients receiving Imbruvica had a 41 percent PFS rate, compared with 7% in those receiving Torisel.
Imbruvica also demonstrated a significantly higher overall response rate versus Torisel (72% versus 40%), and 26 patients who received Janssen’s drug achieved a complete response, while only two patients who received Torisel experienced such a response.
Joel Levy
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