Provider Perceptions of Shine and Ibrutinib, Bendamustine, and Rituximab in the First-Line Setting

Background:

According to the National Cancer Care Network guidelines, chemoimmunotherapy with bendamustine + rituximab (BR) is considered standard first-line (1L) therapy for mantle cell lymphoma (MCL), followed by autologous hematopoietic cell transplant (ASCT) consolidation. Most MCL patients who are refractory to BR therapy and/or ineligible for ASCT will relapse. Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, recently received accelerated approval as a second line (2L) chemotherapy for MCL to help prevent relapse in ASCT- ineligible patients. Expanding upon the success of the ibrutinib' approval in the 2L, the SHINE trial (NCT01776840) sought to determine the efficacy of ibrutinib in combination with BR in the 1L setting as a therapy for older, ASCT-ineligible patients with stage II-IV MCL. At the American Society of Clinical Oncology (ASCO) 2022 annual conference, it was reported that the SHINE trial had satisfied the primary endpoint of improved progression-free survival. We surveyed providers' perceptions of the SHINE trial and the likelihood that they would adopt ibrutinib + BR (IBR) therapy in the 1L setting.

Methods:

At two live events held in June and July of 2022, U.S.-based oncologists who treat MCL (n=89) were invited to hear discussions on select abstracts presented at ASCO 2022, including an abstract on the SHINE trial. The demographic profile of our participant population was collected via a pre-event survey. Participants' perceptions and reactions regarding the SHINE trial were collected in real-time using an electronic keypad. Not all participants who attended answered every survey question. Descriptive statistics were used to assess participants' perceptions and reactions.

Results:

Within a typical 3-month period, 35 (39%) participants reported that they are referred < 1 new patient with MCL, while 34 (37%) participants reported that they are referred ≥ 1 new patient with MCL. Seventy-three (82%) participants self-identified as community providers. Participants possessed an average of 22 years of clinical experience. During clinical hours, the median amount of time participants reported they focus on direct patient care was 90% (20%-100%).

Sixty-three (71%) of participants stated that they prefer standard BR therapy as a 1L therapy for patients diagnosed with MCL. Sixty-four (72%) of the participants reported atrial fibrillation, and 54 (61%) reported bleeding 54 (61%) as the most concerning issues when considering IBR therapy. Sixty-nine (78%) participants agreed that if FDA approved, IBR would be likely adopted as their primary, 1L MCL regimen.

Conclusions:

Overall, our participants' perceptions of the SHINE trial data were positive. Following the presentation of the SHINE trial and data for the IBR regimen in MCL, participants were most concerned with the atrial fibrillation and bleeding adverse events, respectively. Despite these safety concerns, nearly 4 in 5 (78%) participants consider it likely that they would prescribe the IBR regimen based on the SHINE study results and assuming FDA approval, as a 1L therapy for patients diagnosed with MCL. Second generation BTK inhibitors have demonstrably improved safety and efficacy profiles, and many of our participants expressed a desire to see further studies of second generation BTK inhibitors added to the BR therapy backbone as a potential future regimen of interest.

Baird:Cardinal Health Specialty Solutions: Current Employment. Bone:Cardinal Health Specialty Solutions: Current Employment. Jeune-Smith:Cardinal Health Specialty Solutions: Current Employment, Current holder of stock options in a privately-held company. Feinberg:Cardinal Health Specialty Solutions: Current Employment, Current holder of stock options in a privately-held company. Baljevic:Janssen Research: Other: Advisory Boards; Oncopeptides: Other: Advisory Boards; Sanofi-Genzyme: Consultancy, Other: Advisory Boards; Curio Science: Other: Speaker; AJH: Other: Speaker; Karyopharm: Other: Advisory Boards; NCCN: Other: Speaker; BMS/Celgene: Consultancy, Other: Advisory Boards; Cardinal Health Specialty Solutions: Consultancy.