Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as bexobrutideg
NX-5948 · 4 trials · 12 indications
Time from randomization to disease progression per 2018 International Workshop on CLL (iwCLL) or death due to any cause, whichever is earlier
Percentage of participants with best overall response of complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR), or nodular PR, as assessed per 2018 iwCLL guidelines
The percentage of participants with response as determined according to 2018 International Workshop on CLL (iwCLL) guidelines. Response will include complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR), and nodular PR.
Phase 1a
Phase 1a
Phase 1b Part 1
Phase 1a / Phase 1b Part 1
Phase 1b Part 2
| Arm | Type | Description |
|---|---|---|
| Arm A: NX-5948 | EXPERIMENTAL | - |
| Arm B: Pirtobrutinib | EXPERIMENTAL | - |
| NX-5948 | EXPERIMENTAL | - |
| NX-5948 + venetoclax | EXPERIMENTAL | - |
| NX-5948 + venetoclax + rituximab | EXPERIMENTAL | - |
| NX-5948 + venetoclax + obinutuzumab | EXPERIMENTAL | - |
| Phase 1a Dose Escalation | EXPERIMENTAL | Multiple dose levels of NX-5948 to be evaluated; determination of Maximum Tolerated Dose/Phase 1b recommended dose(s) |
| Phase 1b Part 1 Cohort 1 in CLL or SLL with prior BTKi and BCL2i | EXPERIMENTAL | CLL or SLL with prior exposure to both a Bruton's tyrosine kinase inhibitor (BTKi) and BCL-2 inhibitor, unless previously deemed ineligible for a BCL-2i. Patients enrolled in CLL/SLL arm will be randomized to one of two dose levels. |
| Phase 1b Part 1 Cohort 2 in CLL/SLL with non-C481S BTK mutations | EXPERIMENTAL | Prior exposure to both BTKi and BCL-2i (unless deemed ineligible for BCL-2i by Investigator at the time of study enrollment) and documented BTK mutation other than C481S within 6 months prior to study entry |
| Phase 1b Part 1 Cohort 3 in CLL/SLL with prior non-covalent BTKi | EXPERIMENTAL | CLL/SLL with prior exposure to ncBTKi and are BCL-2i naïve. |
| Phase 1b Part 1 Cohort 4 in CLL/SLL with TP53 or 17p deletion, 2L, prior BTKi | EXPERIMENTAL | Patients with documented TP53 mutation or 17p deletion and 1 prior line of therapy that included a BTKi and are BCL-2i naïve. |
| Phase 1b Part 1 Cohort 5 in CLL/SLL with 2L+, prior BTKi | EXPERIMENTAL | Patients with at least 1 prior line of therapy that included a BTKi and are BCL-2i naïve. |
| Phase 1b Part 1 Cohort 6 in MCL | EXPERIMENTAL | Non-blastoid MCL with prior exposure to a BTKi and an anti-CD20 monoclonal antibody (mAb)-based chemoimmunotherapy regimen |
| Phase 1b Part 1 Cohort 7 in MZL | EXPERIMENTAL | MZL (EMZL, MALT, NMZL, SMZL) with prior exposure to an anti-CD20 mAb-based chemo-immunotherapy regimen and an additional line of therapy |
| Phase 1b Part 1 Cohort 8 in WM (3L+) | EXPERIMENTAL | WM with prior exposure to a BTKi and at least an additional line of therapy |
| Phase 1b Part 1 Cohort 9 in WM (2L) | EXPERIMENTAL | WM following upfront therapy with a BTKi |
| Phase 1b Part 1 Cohort 10 in DLBCL | EXPERIMENTAL | DLBCL which transformed from indolent lymphoma or Richters transformation with prior exposure to an anthracycline (unless previously deemed ineligible to receive), an anti-CD20 mAb-based chemoimmunotherapy regimen, and an additional line of therapy |
| Phase 1b Part 1 Cohort 11 in FL | EXPERIMENTAL | FL (grade 1-3a) with prior exposure to an anti-CD20 mAb-based chemoimmunotherapy regimen and an additional line of therapy |
| Phase 1b Part 1 Cohort 12 in PCNSL/SCNSL | EXPERIMENTAL | PCNSL following at least 1 prior line of therapy that included a BTKi (2L+) or following 2 or more prior lines of therapy (3L+), or SCNSL patients meeting criteria for a non-CLL/SLL cohort enrolling that disease with secondary CNS involvement of lymphoma |
| Phase 1b Part 1 Cohort 13 in PCNSL | EXPERIMENTAL | PCNSL following upfront therapy and with no prior exposure to a BTKi (2L). |
| Phase 1b Part 2 in CLL or SLL with prior BTKi and BCL-2i | EXPERIMENTAL | CLL or SLL with prior exposure to both a Bruton's tyrosine kinase inhibitor (BTKi) and BCL-2 inhibitor |
| Phase 1b Part 1 Cohort 14 in first-line WM | EXPERIMENTAL | Treatment-naïve WM deemed unfit for chemoimmunotherapy |
| Phase 1b Part 1 Cohort 15 in BTKi-naive CLL/SLL | EXPERIMENTAL | First-line (1L) or second-line+ (2L)+ CLL/SLL with no prior exposure to a BTKi |
| Phase 1b Part 1 Cohort 16 in CLL/SLL with secondary warm autoimmune hemolytic anemia (wAIHA) | EXPERIMENTAL | BTKi-exposed R/R CLL or SLL with secondary wAIHA |
| Phase 1b Part 1 Cohort 17 in CLL/SLL with CNS involvement | EXPERIMENTAL | BTKi-exposed R/R CLL or SLL with CNS involvement |
| Name | Type | Description |
|---|---|---|
| NX-5948 | DRUG | Administered orally once daily |
| Pirtobrutinib | DRUG | Administered orally once daily per prescribing information |
| venetoclax | DRUG | Administered orally once daily as a tablet per prescribing information |
| rituximab | DRUG | Administered as an intravenous (IV) infusion per prescribing information |
| obinutuzumab | DRUG | Administered as an IV infusion per prescribing information |
Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Adequate organ and bone marrow function * Confirmed diagnosis of CLL/SLL that meets iwCLL 2018 criteria for diagnosis and systemic treatment * Received at least 1 prior line of therapy for CLL/SLL tha...
Top 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 2 | PHASE2 | Ruxolitinib |
NX-5948 is an investigational small molecule being studied for B-cell lymphoma and chronic lymphocytic leukemia (CLL), including small lymphocytic lymphoma. It is also being evaluated in other relapsed or refractory B-cell malignancies such as diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, and Waldenstrom macroglobulinemia. It is not yet approved.
NX-5948 targets Bruton's tyrosine kinase, or BTK. By binding BTK, the drug is designed to interfere with B-cell receptor signaling that supports the growth and survival of malignant B cells. This mechanism underlies its development across B-cell lymphoma and chronic lymphocytic leukemia.
NX-5948 is being developed by Nurix Therapeutics, Inc., which trades on the Nasdaq under the ticker NRIX. Nurix is the sponsor of the clinical program evaluating the drug in B-cell malignancies, including chronic lymphocytic leukemia and small lymphocytic lymphoma.
NX-5948 is in Phase 3 development. The Phase 3 trial compares NX-5948 with pirtobrutinib in relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma. The drug remains investigational and is not FDA approved; earlier Phase 1 and Phase 2 studies are also ongoing.
NX-5948 is being studied in several recruiting trials. These include the Phase 3 NCT07516093 trial versus pirtobrutinib in relapsed or refractory CLL/SLL, the Phase 2 DAYBreak CLL-201 trial NCT07221500, the Phase 1 combination trial NCT07520006, and the Phase 1 trial NCT05131022 in relapsed or refractory B-cell malignancies.
No. NX-5948 and pirtobrutinib are different drugs. NX-5948 is an investigational BTK-targeting small molecule developed by Nurix Therapeutics. Pirtobrutinib is used as the comparator arm in the Phase 3 NCT07516093 trial, which evaluates NX-5948 versus pirtobrutinib in relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma.