Pirtobrutinib + Mosunetuzumab for Follicular Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how pirtobrutinib and mosunetuzumab work together to help people with follicular lymphoma that has returned or not responded to other treatments. Pirtobrutinib blocks a protein that promotes cancer cell growth, while mosunetuzumab aids T cells in attacking the cancer. Combining these treatments might enhance effectiveness and reduce certain side effects. This trial may suit those who have tried at least two other treatments for grade 1-3a follicular lymphoma without success or have experienced a recurrence. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you have used certain cancer treatments or therapies recently, such as monoclonal antibodies or chemotherapeutic agents, within a specified time before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research is investigating the safety of combining pirtobrutinib and mosunetuzumab to treat follicular lymphoma. In other studies, mosunetuzumab demonstrated an 80% response rate, surpassing the 65% seen in real-world data, suggesting strong efficacy. However, safety remains a key concern.
Mosunetuzumab can cause cytokine release syndrome (CRS), a side effect where the immune system releases too many proteins into the blood too quickly. Combining it with pirtobrutinib might help reduce this side effect. Pirtobrutinib blocks certain proteins that aid cancer cell growth and is generally well-tolerated.
This study is in its early stages, focusing primarily on the treatment's safety for participants. While there is hope that combining these drugs may be safe, further research is needed to confirm this.12345Why are researchers excited about this trial's treatments?
Researchers are excited about pirtobrutinib and mosunetuzumab for follicular lymphoma because they bring innovative mechanisms to the table. Unlike most treatments that primarily focus on chemotherapy, pirtobrutinib is a highly selective BTK inhibitor that targets specific proteins involved in the growth of cancer cells, potentially leading to fewer side effects. Mosunetuzumab, on the other hand, is a bispecific antibody that redirects the body's immune system to attack the cancer cells directly. This dual approach not only targets the cancer more precisely but also harnesses the power of the immune system, offering new hope for more effective and targeted treatment.
What evidence suggests that pirtobrutinib and mosunetuzumab could be effective for follicular lymphoma?
Research has shown that mosunetuzumab yields promising results for patients with relapsed or refractory follicular lymphoma. Studies found that 80% of patients experienced a reduction in their cancer. On average, patients lived for 24 months without their cancer worsening. In this trial, participants will receive a combination of mosunetuzumab and pirtobrutinib. Pirtobrutinib blocks a protein called BTK, which aids cancer cell growth. By blocking BTK, pirtobrutinib may help stop cancer growth and enhance the effectiveness of T cell-based treatments like mosunetuzumab. Using these treatments together could improve their ability to kill cancer cells and reduce some side effects.23678
Who Is on the Research Team?
Mengyang Di, MD, PhD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
The PROMOTE-FL trial is for patients with grades 1-3A follicular lymphoma that has either relapsed or hasn't responded to previous treatments. Participants must meet specific health criteria, which are not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pirtobrutinib orally once daily starting 7 days prior to mosunetuzumab and continue for up to 52 weeks. Mosunetuzumab is administered intravenously on days 1, 8, and 15 of cycle 1, then on day 1 of remaining cycles, repeating every 21 days for up to 17 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and then at standard of care intervals for up to 4 years.
What Are the Treatments Tested in This Trial?
Interventions
- Mosunetuzumab
- Pirtobrutinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University