Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SC Mosunetuzumab, Mosunetuzumab (IV), Mosunetuzumab (Cohorts A-C)
Mosunetuzumab · 12 trials · 10 indications
ORR was defined as the percentage of participants with complete response (CR)/partial response (PR), per IRF, per Lugano Response Criteria. Percentages have been rounded off.
PFS was defined as the time from randomization to first occurrence of disease progression (PD) or death from any cause, whichever occurred first, per IRF, per Lugano Response Criteria.
Drug-Free Remission is defined as achieving both of the following: Absence of disease activity maintained for 6 months after completion of mosunetuzumab treatment, and; not receiving any SLE-directed therapy (except for antimalarials) during the 6 months. Doses of prednisone (or equivalent) ≤5 mg/day to treat secondary adrenal insufficiency are permitted.
Using a modified 3+3 design in previously untreated c-Myc rearranged aggressive B cell lymphomas during the safety run-in period (cycle 1-2). Incidence of DLTs will be tabulated by dose level. All DLTs will be coded by system organ class, MedDRA preferred term, and severity grade using Common Terminology Criteria for Adverse Events (CTCAE )(version \[v\] 5.0). Cytokine Release Syndrome/Immune Effector Cell-Associated Neurotoxicity Syndrome (CRS/ICANS) toxicities will be reporting using with the American Society for Transplantation and Cellular Therapy (ASTCT) grading system. Safe dose of mosunetuzumab (or dose adjusted \[DA\] etoposide, doxorubicin, vincristine, cyclophosphamide, and prednisone \[EOPCH\]) will be specified.
Will be reported with exact 95% confidence interval.
The CR rate was defined as the percentage of participants with CR. Assessments were made according to the Lugano 2014 Response Criteria.
| Arm | Type | Description |
|---|---|---|
| M+P (Arm A) | EXPERIMENTAL | Participants will receive subcutaneous (SC) mosunetuzumab plus intravenous (IV) polatuzumab vedotin (M+P). Mosunetuzumab will be administered on Days 1, 8, and 15 of Cycle 1, and thereafter on Day 1 of Cycles 2-8. Polatuzumab vedotin will be administered on Day 1 of each cycle up to Cycle 6. Cycle length = 21 days. |
| R-GemOx (Arm B) | ACTIVE_COMPARATOR | Participants will receive IV rituximab, IV gemcitabine, and IV oxaliplatin (R-GemOx) on Day 1 of each cycle for 8 cycles. Cycle length = 14 days. |
| M + Len (Arm A) | EXPERIMENTAL | Participants will receive mosunetuzumab for 12 cycles, plus lenalidomide from cycles 2-12 (Cycle length = 21 days for Cycle 1; cycle length = 28 days for Cycles 2-12) |
| R + Len (Arm B) | EXPERIMENTAL | Participants will receive weekly rituximab in Cycle 1, then on Day 1 of Cycles 3, 5, 7, 9, and 11. Participants will also receive lenalidomide in Cycles 1-12. (Cycle length = 28 days for Cycles 1-12) |
| M + Len (US Extension Arm C) | EXPERIMENTAL | Participants will receive mosunetuzumab for 12 cycles, plus lenalidomide from cycles 2-12 (Cycle length = 21 days for Cycle 1; cycle length = 28 days for Cycles 2-12) |
| Mosunetuzumab | EXPERIMENTAL | Participants will receive mosunetuzumab by subcutaneous (SC) injection. |
| Cohort A | EXPERIMENTAL | Participants with high tumor burden with untreated follicular lymphoma (FL) will receive SC mosunetuzumab monotherapy for up to 17 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first. Participants that achieve complete or partial metabolic response will have the option of receiving maintenance therapy with mosunetuzumab every 8 weeks for 1 year. |
| Cohort B | EXPERIMENTAL | Elderly participants with untreated diffuse large B-cell lymphoma (DLBCL) will receive SC mosunetuzumab monotherapy for up to 17 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first. |
| Cohort C | EXPERIMENTAL | Participants with untreated marginal zone lymphoma (MZL) will receive SC mosunetuzumab monotherapy for up to 17 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first. |
| Cohort D | EXPERIMENTAL | Participants with relapsed or refractory (R/R) mantle cell lymphoma (MCL) will receive SC mosunetuzumab monotherapy for up to 34 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first. |
| Cohort E | EXPERIMENTAL | Participants with R/R Richter's transformation (RT), or R/R transformed follicular lymphoma (tFL) will receive SC mosunetuzumab monotherapy for up to 34 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first. |
| Treatment (Mosunetuzumab and EPOCH) | EXPERIMENTAL | Patients receive mosunetuzumab IV, over 2-4 hours, on day 1, 8 and 15 of cycle 1 and day 1 of subsequent cycles. Patients receive etoposide IV, doxorubicin IV, and vincristine IV on days 1-4, cyclophosphamide IV, over 2 hours, on day 5 and prednisone PO BID on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity for up to 6 cycles. Patients undergo bone marrow aspiration and biopsy, tumor biopsy and may undergo echocardiography or MUGA at screening and PET scan, CT scan or MRI and blood sample collection throughout the study. |
| Arm 1 | EXPERIMENTAL | Participants will receive subcutaneous (SC) mosunetuzumab + CC-220 (dose escalation only) or SC mosunetuzumab + CC-99282. |
| Arm 2 | EXPERIMENTAL | Participants will receive intravenous (IV) glofitamab + CC-99282. |
| Arm A | EXPERIMENTAL | Participants with R/R CLL/SLL after two prior lines of therapy and who have had prior exposure to BTKi and/or venetoclax will receive mosunetuzumab subcutaneous (SC) monotherapy |
| Arm B | EXPERIMENTAL | Participants with R/R CLL/SLL after two or more prior lines of therapy, who are currently progressing on BTKi therapy, and who require salvage therapy as assessed by their treating physician will receive mosunetuzumab SC with BTKi overlap therapy for up to the first three cycles of mosunetuzumab SC |
| Arm C (non-US participants only) | EXPERIMENTAL | Participants with R/R CLL/SLL after two or more prior lines of therapy and who have had prior exposure to BTKi and/or venetoclax will receive mosunetuzumab SC with venetoclax during dose escalation phase. Participants with R/R CLL/SLL after at least one prior line of therapy must have prior exposure to BTKi and/or venetoclax and \>12 months since last venetoclax exposure will receive mosunetuzumab SC with venetoclax during the dose expansion phase. During the dose expansion phase, a control cohort receiving the standard-of-care regimen of rituximab plus venetoclax has been added (this arm is open only to participants outside of the US). |
| Non-fractionated/Dose-finding | EXPERIMENTAL | Participants will receive a single dose of mosunetuzumab. |
| Fractionated/Dose-escalation | EXPERIMENTAL | Participants will receive a fractionated (divided) dose of mosunetuzumab on Days 1 and 8. |
| Intravenous (IV) Mosunetuzumab + Lenalidomide (Non-randomized) | EXPERIMENTAL | Participants will receive treatment with IV mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward) |
| Subcutaneous (SC) Mosunetuzumab + Lenalidomide (Non-randomized) | EXPERIMENTAL | Participants will receive treatment with SC mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward). Participants that have received complete metabolic response (CMR) or partial metabolic response (PMR) after 12 cycles of induction therapy with mosunetuzumab + lenalidomide will receive maintenance therapy with SC mosunetuzumab every 8 weeks (Q8W) for an additional 9 cycles. |
| Arm A: IV Mosunetuzumab + Len (Randomized) | EXPERIMENTAL | Participants will receive treatment with IV mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward) |
| Arm B: SC Mosunetuzumab + Len (Randomized) | EXPERIMENTAL | Participants will receive treatment with SC mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward) |
| Consolidation Therapy (Cohort A) | EXPERIMENTAL | Participants with a partial response to first-line chemotherapy will receive mosunetuzumab up to the recommended consolidation dose (RCD). |
| Elderly/Unfit Previously Untreated Monotherapy (Cohort B) | EXPERIMENTAL | Elderly/unfit participants with previously untreated DLBCL will receive mosunetuzumab at the previously determined recommended phase II dose (RP2D). |
| Elderly/Unfit Previously Untreated Combination Therapy (Cohort C) | EXPERIMENTAL | Elderly/unfit participants with previously untreated DLBCL will receive mosunetuzumab in combination with polatuzumab vedotin. |
| Phase Ib: Mosunetuzumab (M)-CHOP Dose Finding | EXPERIMENTAL | Participants will receive M-CHOP up to the phase II recommended dose (RP2D). |
| Phase Ib: M-CHP-Pola Dose-Finding | EXPERIMENTAL | Participants will receive M-CHP-Pola up to the RP2D. |
| Phase II: M-CHOP Previously Untreated (1L) DLBCL Safety Cohort | EXPERIMENTAL | Participants with 1L DLBCL will receive mosunetuzumab at the RP2D in combination with CHOP. |
| Phase II: M-CHP-Pola 1L DLBCL | EXPERIMENTAL | Participants with 1L DLBCL will receive M-CHP-Pola at a dose determined in the dose finding stage. |
| Phase II: Rituxumab (R)-CHP-Pola 1L DLBCL | ACTIVE_COMPARATOR | Participants with 1L DLBCL will receive R-CHP-Pola at a dose determined in the dose finding stage. |
| Phase II: M-CHOP 1L DLBCL | EXPERIMENTAL | Participants with 1L DLBCL will receive M-CHOP at a dose determined in the dose finding stage. NOTE: No participants were enrolled to this arm. |
| Dose Finding | EXPERIMENTAL | Participants will receive mosunetuzumab in combination with polatuzumab vedotin. Dose finding will be guided by the observed incidence of dose-limiting toxicities (DLTs) at each dose level. |
| Mosunetuzumab + Polatuzumab Vedotin 2L+ R/R FL | EXPERIMENTAL | Participants with at least one line of prior therapy (2L+) and that have relapsed or refractory (R/R) follicular lymphoma (FL) will receive mosunetuzumab + polatuzumab vedotin. |
| Mosunetuzumab + Polatuzumab Vedotin 2L+R/R DLBCL | EXPERIMENTAL | 2L+ participants with R/R diffuse large B-cell lymphoma will receive mosunetuzumab + polatuzumab vedotin. |
| Mosunetuzumab SC + Polatuzumab Vedotin 3L+R/R MCL | EXPERIMENTAL | Participants with at least 2 lines of prior therapy (3L+) will receive subcutaneous (SC) mosunetuzumab + polatuzumab vedotin. |
| Mosunetuzumab SC + Polatuzumab Vedotin 2L+R/R DLBCL | EXPERIMENTAL | 2L+ participants with R/R DLBCL will receive SC mosunetuzumab and polatuzumab vedotin. |
| Name | Type | Description |
|---|---|---|
| Mosunetuzumab | DRUG | Participants will receive SC mosunetuzumab on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-8 (cycle length = 21 days). |
| Polatuzumab vedotin | DRUG | Participants will receive IV polatuzumab vedotin every three weeks (Q3W) for 6 cycles (cycle length = 21 days). |
| Tocilizumab | DRUG | Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events. |
| Rituximab | DRUG | Participants will receive IV rituximab on Day 1 of each cycle for 8 cycles (cycle length = 14 days). |
| Gemcitabine | DRUG | Participants will receive IV gemcitabine on Day 1 of each cycle for 8 cycles (cycle length = 14 days). |
| Oxaliplatin | DRUG | Participants will receive IV oxaliplatin on Day 1 of each cycle for 8 cycles (cycle length = 14 days). |
| Lenalidomide | DRUG | Participants will receive oral lenalidomide once daily on Days 1-21 of Cycles 2-12 (M + Len) or Cycles 1-12 (R + Len) |
| Tociluzumab | DRUG | Tocilizumab will be administered as needed to manage cytokine release syndrome (CRS) events |
| Mosunetuzumab (Cohorts A-C) | DRUG | Participants will receive SC mosunetuzumab for up to 17 cycles and for optional maintenance (Cohort A only) |
| Mosunetuzumab (Cohorts D-E) | DRUG | Participants will receive SC mosunetuzumab for up to 34 cycles |
| Biopsy | PROCEDURE | Undergo tumor biopsy |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Marrow Aspiration and Biopsy | PROCEDURE | Undergo bone marrow aspiration and biopsy |
| Computed Tomography | PROCEDURE | Undergo CT scan |
| Cyclophosphamide | DRUG | Given IV |
| Doxorubicin | DRUG | Given IV |
| Echocardiography | PROCEDURE | Undergo echocardiography |
| Etoposide | DRUG | Given IV |
| Magnetic Resonance Imaging | PROCEDURE | Undergo MRI |
| Multigated Acquisition Scan | PROCEDURE | Undergo MUGA |
| Positron Emission Tomography | PROCEDURE | Undergo PET scan |
| Prednisone | DRUG | Given PO |
| Vincristine | DRUG | Given IV |
| SC Mosunetuzumab | DRUG | Participants will receive SC mosunetuzumab for 12 cycles (cycle length = 21 days or 28 days for Cycle 1 and 28 days for Cycles 2-12) |
| IV Glofitamab | DRUG | Participants will receive IV glofitamab for 12 cycles (cycle length = 21 days) |
| Iberdomide | DRUG | Arm 1: Participants will receive oral CC-220 from Day 1-21 of Cycle 2-12 (cycle length = 28 days for Cycles 2-12) |
| Golcadomide | DRUG | Arm 1: Participants will receive oral golcadomide from Day 1-14 starting in either Cycle 1 or Cycle 2 through Cycle 12 (cycle length = 28 days for cycles when golcadomide is to be administered) Arm 2: Participants will receive oral golcadomide from Day 1-10 starting in either Cycle 1, Cycle 2 or Cycle 3 through Cycle 12 (cycle length = 21 days) |
| Obinutuzumab | DRUG | Participants in Arm 2 will receive pre-treatment with IV obinutuzumab on Cycle 1 Day 1 (cycle length = 21 days) |
| Venetoclax | DRUG | Participants will receive daily oral venetoclax. |
| Mosunetuzumab (IV) | DRUG | Participants will receive IV mosunetuzumab as defined by the study protocol |
| Mosunetuzumab (SC) | DRUG | Participants will receive SC mosunetuzumab as defined by the study protocol |
| Mosunetuzumab Intravenous (IV) | DRUG | Participants in cohorts A and B will receive IV mosunetuzumab. |
| Mosunetuzumab Subcutaneous (SC) | DRUG | Participants in Cohort C will receive SC mosunetuzumab. |
| Rituxumab | DRUG | Participants will receive rituxumab via IV. |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 * CD20+ aggressive lymphoma as determined by the local hemopathology laboratory from the following diagnoses by 2016 World Health Organization classification of lymphoid neoplasms: DLBCL, not otherwise ...
Mosunetuzumab is an investigational antibody being studied for Diffuse Large B-cell Lymphoma, Non-Hodgkin Lymphoma, B-cell Non-Hodgkin Lymphoma, Relapsed or Refractory Follicular Lymphoma, Follicular Lymphoma, and Lupus. It is in Phase 1 clinical development for these conditions.
Mosunetuzumab is a monoclonal antibody (mab) that targets CD20 on B-cells. It is designed to engage T-cells to eliminate malignant B-cells in B-cell malignancies and modulate B-cells in autoimmune conditions like Lupus.
Mosunetuzumab is developed by Roche Holding AG, traded on the OTC market under the ticker RHHBY. The company is conducting multiple Phase 1 trials of the drug across oncology and autoimmune indications.
Mosunetuzumab is in Phase 1 clinical development. It is investigational and not yet approved by regulatory authorities. All four listed trials are Phase 1 studies, with three active or recruiting and one completed.
Mosunetuzumab is being studied in four Phase 1 trials: NCT03677154 in Diffuse Large B-cell Lymphoma, NCT04246086 in Follicular Lymphoma, NCT05155345 in Systemic Lupus Erythematosus, and NCT06249191 in Diffuse Large B-cell Lymphoma and High Grade B-Cell Lymphoma.
Yes, SC Mosunetuzumab refers to the subcutaneous formulation of Mosunetuzumab. The drug is also known as Mosunetuzumab (IV) for the intravenous formulation and Mosunetuzumab (Cohorts A-C) in certain trial cohorts.