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Single-Agent Ibrutinib Promising in MCL and CLL, Improves Patient Well-Being

Surabhi Dangi-Garimella, PhD
Three studies presented at the ongoing 59th Annual Meeting and Exposition of the American Society of Hematology in Atlanta, Georgia, shared progress on the oral Bruton’s tyrosine kinase inhibitor, ibrutinib, in the treatment of relapsed/refractory mantle cell lymphoma (MCL) and as a single agent in chronic lymphocytic leukemia (CLL).
Three studies presented at the ongoing 59th Annual Meeting and Exposition of the American Society of Hematology (ASH), Atlanta, Georgia, shared progress on the oral Bruton’s tyrosine kinase inhibitor, ibrutinib, in the treatment of relapsed/refractory mantle cell lymphoma (MCL) and as a single agent in chronic lymphocytic leukemia (CLL).

The MCL results were a 3.5-year follow-up of a pooled analysis of 370 patients with relapsed/refractory MCL who were treated with ibrutinib as part of 3 open-label studies: SPARK, RAY, and PCYC-1104. This longer-term follow-up, which included additional exposure to treatment, was conducted in 87 patients across the 3 studies who enrolled in the long-term access study CAN3001—a phase 3b open-label study.1

Patients received 560 mg ibrutinib orally, once daily, until progressive disease or unacceptable toxicity. Patients in the SPARK study were required to have received both rituximab and bortezomib, while those in the RAY study required prior treatment with rituximab. Only those patients who continued to benefit from ibrutinib therapy at end of the study could enroll in CAN3001. Crossover patients were excluded from the final pooled analysis. The study evaluated investigator-assessed tumor response, progression-free survival (PFS), and overall survival (OS). The median duration of follow-up in the pooled data set was 41.1 months (95% CI, 37.3-42.5); median treatment exposure was 11.1 months (range, 0.03-72.1). Fifty-four of the 87 (62.1%) patients enrolled in CAN3001 remain on ibrutinib, and had received at least 2 prior lines of treatment (LOT)

At 41-months follow-up, 26.5% patients achieved complete response (CR). Median PFS was 13.0 months in the overall patient population; in patients with 1 prior LOT, PFS was 33.6 months (range, 19.4-42.1) and in patients achieving CR, PFS was 46.2 months (range, 42.1-not estimable). Median OS was 26.7 months:
  • 53% patients were alive at 2 years (95% CI, 0.47-0.58)
  • 45% patients were alive at 3 years (95% CI, 0.39-0.50)
  • 37% patients were alive at 5 years (95% CI, 0.25-0.49)
Grade 3 or greater treatment-related adverse events occurred in 295 (79.7%) patients, with the new onset events decreasing after the first year, the authors reported. The most common grade ≥ 3 TEAEs were neutropenia (17.0%), thrombocytopenia (12.2%), pneumonia (11.9%), anemia (9.5%), atrial fibrillation (5.9%), and hypertension (5.1%)—a majority were more common during the first year of ibrutinib treatment. Treatment-emergent severe adverse events (SAEs) occurred in 229 (61.9%) patients and new-onset SAEs decreased over time.

Another presentation at the meeting reported results from a crossover study that compared single-agent ibrutinib (RESONATE-2) and chemoimmunotherapy regimens in treatment-naïve patients with CLL from published studies with the following regimens:2                    
  • Fludarabine + cyclophosphamide + rituximab (FCR) from CLL8 (FCR-CLL8), published in The Lancet3
  • Bendamustine + rituximab (BR) and FCR from CLL10 (FCR-CLL10), published in Lancet Oncology4
  • Obinutuzumab + Clb (G-Clb) and R-Clb from CLL11, published in The New England Journal of Medicine5
  • Ofatumumab + Clb (Ofa-Clb) from COMPLEMENT-1, published in The Lancet6


 
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