Janssen‘s Imbruvica (ibrutinib) – an approved therapy for relapsed or refractory mantle cell lymphoma – continues to show promising survival outcomes in these patients, particularly among those who received the treatment after the first relapse and those who achieved a complete response.
The findings will be presented at the upcoming 59th American Society of Hematology (ASH) Annual Meeting & Exhibition, Dec. 9-12 in Atlanta, Georgia. The oral presentation, titled “Median 3.5-Year Follow-up of Ibrutinib Treatment in Patients with Relapsed/Refractory Mantle Cell Lymphoma: A Pooled Analysis,” will reveal results of long-term Imbruvica use in mantle cell lymphoma patients followed for a median of 3.5 years.
“This year’s ASH meeting promises important updates for approved and investigational compounds across our hematology portfolio,” Peter Lebowitz, MD, PhD, global therapeutic area head of oncology, Janssen Research & Development, said in a press release.
In previous clinical trials – Phase 2 SPARK (NCT01599949), Phase 3 RAY (NCT01646021), and Phase 2 PCYC-1104 (NCT01236391) studies – Janssen researchers evaluated Imbruvica’s efficacy in 370 patients with relapsed or refractory mantle cell lymphoma.
Patients enrolled in these studies received 560 mg of oral Imbruvica, once a day. Treatment continued until they showed signs of disease progression or unacceptable toxicity.
Then, the Phase 3b open-label CAN3001 study (NCT01804686) enrolled those who, at the end of the previous studies, continued to benefit from Imbruvica therapy. In total, 87 entered the CAN3001 trial.
To examine the long-term effectiveness of Imbruvica in relapsed or refractory mantle cell lymphoma, researchers pooled data from the four trials. In the pooled analysis, patients received Imbruvica for a median period of 11.1 months and were followed for a median of 3.5 years.
Eighty-three patients received Imbruvica for more than three years, and 40 patients for more than four years. Currently, 54 patients in the CAN3001 study (62.1 percent) remain on Imbruvica.
The pooled analysis was limited to patients who received Imbruvica since entry into the study, excluding those treated previously with a comparator therapy before crossing over to Imbruvica.
Researchers determined the time to disease progression or death and overall survival (OS), based on the number of prior lines of therapy and best tumor response. Patients had a median of two prior lines of therapy before receiving Imbruvica.
After 3.5 years of follow up, the proportion of patients achieving complete response – the disappearance of all signs of cancer in response to treatment – increased to 26.5 percent. In the second and third year, 36 percent and 26 percent of the patients were progression-free, with a median progression-free survival of 13 months.
Patients who received one prior line of therapy had a median progression-free survival of 33.6 months, while those with more than one prior line of therapy had a median of 8.4 months before seeing their disease progress.
Median overall survival of the 370 patients was 26.7 months. And 37 percent of patients were alive at year five. However, for patients who achieved a complete response, more than half were still alive at the time of the analysis. And they took a median 46.2 months before seeing their disease progress.
Treatment-emergent adverse events of grade 3 or higher occurred in 79.7 percent of the patients, but decreased over time. The most common treatment-emergent adverse events were low levels of a type of immune cells, low platelet counts, pneumonia, anemia, heart problems, and hypertension.
Overall, the results show that “more than a quarter of patients remained progression free and nearly half were alive at 3 years,” the researchers said.