Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RO7247669
Tobemstomig · 6 trials · 7 indications
ORR is defined as the percentage of participants who experience a complete reponse or partial response on two consecutive occasions at least 4 weeks apart as determined by the investigator according to RECIST v1.1.
pRR was defined as the percentage of participants with pathologic complete response (pCR), pathologic near complete response (pnCR), and pathologic partial response (pPR) as determined by an independent pathologic review. pCR was defined as a complete absence of viable tumor cells, pnCR as \> 0 to ≤ 10% of viable tumor cells, and pPR was defined as \> 10 to ≤ 50% of viable tumor cells in the dissected lymph node. Participants with missing or no pathologic response assessment, including participants who did not proceed to complete lymph node dissection (CLND), were classified as non-responders. pRR was calculated for each arm along with 95% confidence intervals (CIs) using Clopper-Pearson method. The difference in pRR between the experimental arms and the control arm was calculated, along with 95% CIs using the Wald method with continuity correction.
ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in the short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Participants with missing or no response assessments were classified as non-responders. ORR was calculated for each arm, along with 95% CIs using Clopper-Pearson method.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Participants will receive tobemstomig every 3 weeks, plus nab-paclitaxel administered on a repeating schedule of 3 weeks on, 1 week off, until disease progression or until up to 24 months after the first treatment, whichever is sooner. |
| Arm B | ACTIVE_COMPARATOR | Participants will receive pembrolizumab every 3 weeks, plus nab-paclitaxel administered on a repeating schedule of 3 weeks on, 1 week off, until disease progression or until up to 24 months after the first treatment, whichever is sooner. |
| Arm A (Tobemstomig + Axitinib) | EXPERIMENTAL | Participants will receive intravenous (IV) tobemstomig every three weeks (Q3W) on Day 1 of each 21-day cycle. Participants will also receive oral (PO) axitinib twice daily (BID). |
| Arm B (Tobemstomig + Tiragolumab + Axitinib) | EXPERIMENTAL | Participants will receive IV tobemstomig followed by IV tiragolumab Q3W on Day 1 of 21-day cycle. Participants will also receive axitinib PO BID. |
| Control Arm (Pembrolizumab + Axitinib) | ACTIVE_COMPARATOR | Participants will receive IV pembrolizumab Q3W on Day 1 of each 21-day cycle. Participants will also receive axitinib PO BID. |
| Arm A: Tobemstomig + Platinum-Based Chemotherapy | EXPERIMENTAL | Participants with non-squamous (NSQ) NSCLC will receive induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin, all on Day 1 every 3 weeks (Q3W) for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig together with pemetrexed until disease progression or treatment discontinuation. Participants with squamous (SQ) NSCLC will receive blinded tobemstomig in combination with paclitaxel and carboplatin, all on Day 1 Q3W for four 21 day cycles, followed by blinded tobemstomig (on Day 1) Q3W until disease progression or treatment discontinuation. |
| Arm B: Pembrolizumab + Platinum-Based Chemotherapy | ACTIVE_COMPARATOR | Participants with NSQ NSCLC will receive induction treatment with blinded pembrolizumab in combination with pemetrexed and carboplatin, all on Day 1 Q3W for four 21-day cycles, followed by a maintenance therapy with blinded pembrolizumab together with pemetrexed Q3W until disease progression or treatment discontinuation. Participants with SQ NSCLC will receive blinded pembrolizumab in combination with paclitaxel and carboplatin, all on Day 1 Q3W for four 21-day cycles, followed by blinded pembrolizumab (on Day 1) Q3W until disease progression or treatment discontinuation. |
| Low dose every three weeks (Q3W) | EXPERIMENTAL | Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months. |
| High dose Q3W | EXPERIMENTAL | Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months. |
| Cohort 1: Nivolumab + Ipilimumab | ACTIVE_COMPARATOR | Cohort 1 participants in the nivolumab plus ipilimumab arm will receive treatment for 2 cycles (6 weeks) on Day 1 of each cycle (cycle length 21 days) until surgery, or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. |
| Cohort 1: RO7247669 2100 mg | EXPERIMENTAL | Cohort 1 participants in the RO7247669 arm will receive treatment for 2 cycles (6 weeks) until surgery, or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. |
| Cohort 1: + Atezolizumab + Tiragolumab | EXPERIMENTAL | Cohort 1 participants in the atezolizumab plus tiragolumab arm will receive treatment for 2 cycles (6 weeks) until surgery, or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. |
| Cohort 1: RO7247669 2100 mg + Tiragolumab | EXPERIMENTAL | Cohort 1 participants in the RO7247669 plus tiragolumab arm will receive treatment for 2 cycles (6 weeks) until surgery, or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. |
| Cohort 2: RO7247669 2100 mg + Tiragolumab | EXPERIMENTAL | Cohort 2 participants in RO7247669 plus tiragolumab arm will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. |
| Cohort 1: RO7247669 600 mg | EXPERIMENTAL | Cohort 1 participants in the RO7247669 arm will receive treatment for 2 cycles (6 weeks) until surgery, or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. |
| Cohort 1: RO7247669 600 mg + Tiragolumab | EXPERIMENTAL | Cohort 1 participants in the RO7247669 plus tiragolumab arm will receive treatment for 2 cycles (6 weeks) until surgery, or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. |
| Part A: Single-Agent Dose Escalation | EXPERIMENTAL | Participants will receive RO7247669 every 2 weeks (Q2W) or every 3 weeks (Q3W) up to the maximum tolerated dose (MTD) until disease progression, unacceptable drug toxicity, or withdrawal of consent, for up to 24 months. |
| Part B: Tumor Specific Expansion Cohorts | EXPERIMENTAL | Participants with selected solid tumor indications will receive RO7247669 at a dose derived from Part A until disease progression, unacceptable drug toxicity, or withdrawal of consent, for up to 24 months. |
| Name | Type | Description |
|---|---|---|
| Tobemstomig | DRUG | Participants will receive intravenous (IV) tobemstomig every 3 weeks (Q3W) until disease progression or until up to 24 months after the first treatment, whichever is sooner. |
| Pembrolizumab | DRUG | Participants will receive IV pembrolizumab Q3W until disease progression or until up to 24 months after the first treatment, whichever is sooner. |
| Nab-Paclitaxel | DRUG | Participants will receive IV nab-paclitaxel weekly for 3 weeks, followed by 1 week off, until disease progression or until up to 24 months after the first treatment, whichever is sooner. |
| Tiragolumab | DRUG | Participants will receive IV tiragolumab Q3W. |
| Axitinib | DRUG | Participants will receive axitinib PO BID. |
| Paclitaxel | DRUG | Participants will receive IV paclitaxel Q3W for four 21-day cycles |
| Pemetrexed | DRUG | Participants will receive IV pemetrexed Q3W until disease progression or unacceptable toxicity |
| Carboplatin | DRUG | Participants will receive IV carboplatin Q3W for four 21-day cycles |
| RO7247669 | DRUG | Participants will receive intravenous (IV) RO7247669 Q3W |
| Nivolumab | DRUG | Nivolumab will be administered at a dose of 3 mg/kg IV on Day 1 of each 21 day cycle. |
| Ipilimumab | DRUG | Ipilimumab will be administered at a dose of 1 mg/kg by IV on Day 1 of each 21 day cycle. |
| RO7247669 2100 mg | DRUG | RO7247669 will be administered at a dose of 2100 mg by IV infusion on Day 1 of each 21 day cycle. |
| Atezolizumab | DRUG | Atezolizumab will be administered at a dose of 1200 mg IV on Day 1 of each 21 day cycle. |
| RO7247669 600 mg | DRUG | RO7247669 will be administered at a dose of 600 mg by IV infusion on Day 1 of each 21 day cycle. |
Inclusion Criteria: * Metastatic or locally advanced unresectable, histologically documented triple-negative breast cancer (TNBC) (absence of HER2-over-expression, ER, and PgR expression by local assessment) * HER2-low-status * Measurable disease per Response Evaluation Criteria in Solid Tumors (RE...
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Tobemstomig is an investigational cancer therapy being studied in several tumor types, including breast cancer, melanoma, non-small cell lung cancer, renal cell carcinoma, and other solid tumors. It is being evaluated in Phase 2 clinical trials, both as a single agent and in combination with other treatments such as nab-paclitaxel, axitinib, and platinum-based chemotherapy.
Tobemstomig targets PD-1 and LAG-3, two immune checkpoint proteins. By binding both targets, it is designed to block inhibitory signals that suppress T-cell activity, thereby aiming to enhance the immune system's ability to recognize and attack tumor cells. This dual-target approach distinguishes it from single-agent checkpoint inhibitors.
Tobemstomig is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is running the clinical development program for the drug across multiple solid tumor indications, including breast cancer, melanoma, non-small cell lung cancer, and renal cell carcinoma.
Tobemstomig is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 2 program includes randomized, double-blind, active-controlled trials evaluating the drug in several cancer types, with a total enrollment of 203 participants across completed and active studies.
Tobemstomig has been studied in trials including NCT05852691 in PD-L1-positive triple-negative breast cancer, NCT05805501 in renal cell carcinoma, NCT05775289 in non-small cell lung cancer, and NCT05419388 in melanoma. These are Phase 2 studies, and several have been completed while others are active but no longer recruiting.
Yes, Tobemstomig is also known as RO7247669. The designation RO7247669 2100 mg refers to a specific dose level used in clinical testing. Researchers and publications may use either name when referring to the same investigational anti-PD-1/LAG-3 antibody developed by Roche.