Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TEN-010
RO6870810 · 4 trials · 6 indications
DLT is defined as any of the toxicities- occurs within the first cycle for which the participant receives the full intended combination doses and number of administrations; is considered to be related to study treatment by the investigator; is not attributed to disease progression or another clearly identifiable cause.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
DLTs are defined as the toxicities known and expected of RO6870810 and daratumumab that occur during a DLT assessment window of 21 days from the first administration of RO6870810 or study combination treatments, and are considered by the Investigator to be related to study treatment. DLTs are defined at specific severity levels for each term and include, but are not limited to the following Common Terminology Criteria for Adverse Events (CTCAE) terms: neutropenia, febrile neutropenia, thrombocytopenia, anemia and injection site reaction.
ORR is defined as the percentage of participants whose confirmed best overall response is either complete response (CR, including stringent complete response \[sCR\]) or partial response (PR, including very good partial response \[VGPR\]), assessed with use of the IMWG criteria. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow aspirates. sCR: CR plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. PR: \>/=50% reduction of serum M-protein plus reduction in 24h urinary M-protein by \>/=90% or to \<200 mg/24h. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis; or \>/=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24h. ORR= CR + sCR + PR + VGPR
PFS is defined as the time from first study treatment to the first occurrence of disease progression (per IMWG criteria) or death, whichever occurs first. Disease progression is defined as an increase of \>/= 25% from lowest response value in any one or more of the following: serum M-component, urine M-component, in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (the absolute increase must be \>10 mg/dL), bone marrow plasma cell percentage (absolute level \>/= 10%), definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas, development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.
DoR is defined as the time from the first occurrence of a documented objective response (sCR, CR, VGPR, or PR) to the time of first disease progression per IMWG criteria or death from any cause, whichever occurs first. Disease progression is defined as an increase of \>/= 25% from lowest response value in any one or more of the following: serum M-component, urine M-component, in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (the absolute increase must be \>10 mg/dL), bone marrow plasma cell percentage (absolute level \>/= 10%), definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas, development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.
OS is defined as the time from study enrollment until death from any cause.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Phase (Part 1) | EXPERIMENTAL | Participants will receive either RO6870810 and venetoclax or RO6870810 and venetoclax along with rituximab until disease progression, unacceptable toxicities or withdrawal from treatment for other reasons, or death. |
| Expansion Phase (Part 2) | EXPERIMENTAL | Participants will receive RO6870810 and venetoclax along with rituximab (or RO6870810 and venetoclax, if the combination of the 3 drugs is not tolerable) at a recommended dose established in dose escalation phase until disease progression, unacceptable toxicities or withdrawal from treatment for other reasons, or death. |
| RO6870810 | EXPERIMENTAL | Participants will be administered RO6870810 monotherapy at ascending-dose levels during the dose escalation phase followed by an expansion phase during which RO6870810 will be administered as monotherapy at the recommended dose. Participants will continue to receive study drug as long as they experience clinical benefit in the opinion of the Investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression, as determined by the Investigator after an integrated assessment of IMWG response criteria, biopsies/aspirate (if applicable), and clinical status, or withdrawal of consent. |
| RO6870810 + Daratumumab | EXPERIMENTAL | Participants will be administered RO6870810 at ascending-dose levels in combination with daratumumab at the recommended dose during the dose escalation phase followed by an expansion phase during which both RO6870810 and daratumumab will be administered each at their recommended dose. Participants will continue to receive the study drugs as long as they experience clinical benefit in the opinion of the Investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression, as determined by the Investigator after an integrated assessment of IMWG response criteria, biopsies/aspirate (if applicable), and clinical status, or withdrawal of consent. |
| RO6870810 (Part 1) | EXPERIMENTAL | Participants will receive escalated doses of RO67870810 SC. RO6870810 will be escalated at a starting dose of 0.03 milligrams per kilogram (mg/kg) to a maximum of 0.85 mg/kg. Treatment will be administered in treatment cycles of either 21 days or 28 days and continued until PD, adverse events which justify treatment withdrawal, non-adherence, non-compliance, investigator decision, lost to follow-up, enrollment in other clinical study, or unacceptable toxicity. |
| RO6870810 (Part 2) | EXPERIMENTAL | Participants will receive RO6870810 at doses up to the MTD or up to the highest dose tested if the MTD is not defined. Treatment will be administered in treatment cycles of either 21 days or 28 days and continued until PD, adverse events which justify treatment withdrawal, non-adherence, non-compliance, investigator decision, lost to follow-up, enrollment in other clinical study, or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| RO6870810 | DRUG | RO6870810 subcutaneously (SC) at dose of 0.30, 0.45, or 0.65 milligram per kilogram (mg/kg) on Days 1-14 of 21-day cycles. |
| Venetoclax | DRUG | Venetoclax tablets orally at dose of 400 mg once daily (QD) continuously for 21 days. |
| Rituximab | DRUG | Rituximab intravenously (IV) at dose of 375 mg/m\^2 weekly during the first 21-day cycle (C1) and on day 1 of each cycle thereafter. |
| daratumumab | BIOLOGICAL | Daratumumab will be administered intravenously (IV) at a dose of 16 milligrams/kilogram (mg/kg) of body weight weekly for the first 8 weeks, every two weeks for the following 16 weeks, and every four weeks thereafter, until disease progression. |
Inclusion Criteria * Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2. * Life expectancy \>3 months as per investigator's assessment. * Part 1 and Part 2 Group 1: Participantts with diffuse large B-cell lymphoma (DLBCL) relapsed or refractory to ≥ 1 course of chemotherapy includin...
RO6870810 is an investigational small molecule developed by Roche Holding AG (ticker RHHBY) for oncology indications. It has been studied in Phase 1 clinical trials in acute myeloid leukemia, diffuse large B-cell lymphoma, multiple myeloma, myelodysplastic syndromes, and advanced solid tumors. It is a BET bromodomain inhibitor and is not an approved therapy.
RO6870810 targets the bromodomain and extra-terminal (BET) family proteins BRD2, BRD3, BRD4, and BRDT. It acts as an inhibitor of these bromodomain proteins, which are involved in regulating gene transcription. This mechanism underlies its investigation as an anticancer agent across hematologic and solid tumor settings.
RO6870810 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the Phase 1 clinical program evaluating the compound in hematologic malignancies and advanced solid tumors. The drug is also referenced in some study titles under the code TEN-010.
RO6870810 is in Phase 1 clinical development. All of its recorded trials are Phase 1 studies, and they have been completed. The drug is investigational and has not been approved by the FDA for any indication. No active trials of RO6870810 are currently listed.
RO6870810 has been evaluated in four completed Phase 1 trials: NCT03255096 in relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma, NCT03068351 in advanced multiple myeloma, NCT02308761 in acute myeloid leukemia and myelodysplastic syndromes, and NCT01987362 in advanced solid tumors. These studies enrolled a combined total of 141 participants.
Yes, RO6870810 is also known as TEN-010. The alternative code appears in the title of the Phase 1 study NCT02308761, which evaluated RO6870810/TEN-010 in participants with acute myeloid leukemia and myelodysplastic syndrome. Both names refer to the same Roche BET bromodomain inhibitor compound.