BGB-16673 vs Pirtobrutinib for Chronic Lymphocytic Leukemia

Recruiting at 17 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: BeiGene

Must be taking: Covalent BTK inhibitors

Must not be taking: BTK protein degraders

Disqualifiers: Prolymphocytic leukemia, Bleeding disorders, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 3 years

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, BGB-16673 and pirtobrutinib, for individuals with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose disease has returned or not responded to previous treatments. The researchers aim to determine which treatment is more effective and safe for patients previously treated with a covalent Bruton tyrosine kinase inhibitor, a specific cancer treatment. Suitable candidates for this trial have CLL or SLL requiring treatment and have already tried at least one therapy that included this type of medicine. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients access to potentially effective treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found BGB-16673 to be generally safe and tolerable for patients with relapsed or hard-to-treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Researchers discovered that it worked well even at low doses, with most patients not experiencing serious side effects.

Studies have also shown that pirtobrutinib has a good safety record, meaning most people taking it did not have severe side effects. It remains effective even in patients with certain resistance mutations, which are changes in cancer cells that make them harder to treat.

Both treatments have been tested in patients similar to those who might consider joining this trial, and they have shown to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BGB-16673 for Chronic Lymphocytic Leukemia (CLL) because it offers a unique approach by targeting specific proteins involved in cancer cell survival, potentially leading to more effective results. Unlike many current treatments that focus on broader mechanisms, BGB-16673 zeroes in on these specific targets, which might result in fewer side effects and improved patient outcomes. Pirtobrutinib, another treatment in comparison, is notable for its ability to maintain effectiveness even when other similar drugs fail, providing a promising option for patients who have developed resistance to existing therapies. These innovative approaches offer hope for more personalized and effective CLL management.

What evidence suggests that this trial's treatments could be effective for chronic lymphocytic leukemia?

This trial will compare BGB-16673 and Pirtobrutinib for treating chronic lymphocytic leukemia (CLL). Studies have shown that BGB-16673 is promising, with 84.8% of patients experiencing their cancer shrinking or stopping its growth, and 77.4% not seeing their disease worsen over time. Participants in one arm of this trial will receive BGB-16673. Pirtobrutinib, which participants in another arm will receive, has also proven effective, with a 62% response rate in patients who had many previous treatments. It has helped patients live longer without their cancer worsening. Both treatments have shown encouraging results for those with relapsed or difficult-to-treat CLL/SLL. ^{1 2 4 6 7}

Who Is on the Research Team?

Study Director

Principal Investigator

BeOne Medicines

Are You a Good Fit for This Trial?

This trial is for adults with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma that has come back or didn't respond after treatment with a specific inhibitor. Participants must have had at least one prior therapy including this inhibitor and meet certain diagnostic criteria.

Inclusion Criteria

I have been diagnosed with CLL or SLL and need treatment.

My CLL/SLL has not improved after treatment with a specific type of medication.

I have SLL with at least one lymph node larger than 1.5 cm.

Exclusion Criteria

I have not had a stroke or brain bleed in the last 6 months.

I have or am suspected to have had a specific type of leukemia or a condition where my leukemia has changed into a more aggressive form.

I have a bleeding disorder like hemophilia or von Willebrand disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either BGB-16673 or pirtobrutinib orally for the duration of the study

Up to approximately 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BGB-16673
• Pirtobrutinib

Trial Overview The study compares the safety and effectiveness of BGB-16673 to Pirtobrutinib in patients whose disease returned or resisted treatment after using a Bruton tyrosine kinase inhibitor, which is a type of targeted cancer drug.

How Is the Trial Designed?

Group I: Arm A: BGB-16673 Experimental Treatment 1 Intervention

Participants will receive BGB-16673 orally.

Group II: Arm B: Pirtobrutinib Active Control 1 Intervention

Participants will receive pirtobrutinib orally.

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+

BeOne Medicines

Lead Sponsor

Citations

1. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/885/530857/Preliminary-Efficacy-and-Safety-of-the-Bruton

Preliminary Efficacy and Safety of the Bruton Tyrosine Kinase ... Conclusions: Emerging data from this ongoing, first-in-human study demonstrate that the novel BTK degrader BGB-16673 has a tolerable safety ...

2. haematologica.org haematologica.org/article/view/12820

C056 | UPDATED EFFICACY/SAFETY OF THE BRUTON ... CONCLUSIONS: Novel BTK degrader BGB-16673 is tolerable, with robust and deepening responses in pts with heavily pretreated R/R CLL/SLL, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06973187

A Study to Evaluate the Safety and Efficacy of BGB-16673 ... The purpose of this study is to evaluate the efficacy and safety of BGB-16673 alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) ...

4. onclive.com onclive.com/view/bgb-16673-is-safe-elicits-nearly-85-orr-in-relapsed-refractory-cll-sll

BGB-16673 Is Safe, Elicits Nearly 85% ORR in Relapsed/ ... BGB-16673 showed safety and efficacy in relapsed/refractory CLL/SLL, with an 84.8% overall response rate and 77.4% progression-free survival at ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2300696

Pirtobrutinib after a Covalent BTK Inhibitor in Chronic ... In this trial, pirtobrutinib showed efficacy in patients with heavily pretreated CLL or SLL who had received a covalent BTK inhibitor.

6. onclive.com onclive.com/view/dr-scarf-on-early-safety-data-with-bgb-16673-in-r-r-cll-sll

Dr Scarfò on Early Safety Data With BGB-16673 in R/R ... “The safety profile appears [to be] tolerable and manageable according to what we know about previous [BTK-targeted] agents.”.

7. cllsociety.org cllsociety.org/2024/10/btk-degrader-demonstrates-safety-for-relapsed-and-refractory-cll/

BTK Degrader Demonstrates Safety for Relapsed and ... BGB-16673 is producing impressive early results in difficult-to-treat patients running out of options. It worked at low doses and in patients resistant to ...