Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MTIG7192A, RO7092284
Tiragolumab · 9 trials · 9 indications
PFS was defined as the time from randomization to the first occurrence of PD, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurred first in the PAS. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the sum must also demonstrate an absolute increase of ≥ 5 millimeters (mm) and unequivocal progression of existing non-target lesions. Kalpan-Meier (K-M) method was used to estimate median PFS.
OS was defined as the time from randomization to death from any cause in the PAS. K-M method was used to estimate median OS.
Progression-free survival rate as measured by the proportion of patients free of progression after 12-weeks of treatment
Number of patients with adverse events as measured according to CTCAE v5.0
An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention.
As defined by investigator-assessed ORR according to RECIST v1.1
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. Kaplan-Meier (KM) methodology was used to estimate the median PFS.
OS was defined as the time from randomization to death from any cause. KM methodology was used to estimate the median OS.
ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the IRC according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR=Disappearance of all target \& non-target lesions or any pathological lymph nodes (whether target or non-target) have reduction in short axis to \<10 millimeters (mm). PR=At least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. The study enrolled participants with measurable disease as determined by the investigator. Participants found to have non-measurable disease at baseline according to RECIST v1.1 (through IRC assessment or Protocol Deviations) were only considered responders if they achieved a CR. Percentages have been rounded off.
| Arm | Type | Description |
|---|---|---|
| Tiragolumab + Atezolizumab + Carboplatin and Etoposide | EXPERIMENTAL | Induction treatment with tiragolumab plus atezolizumab and CE will be administered on a 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with tiragolumab plus atezolizumab for 21-day cycles. |
| Placebo + Atezolizumab + Carboplatin and Etoposide | PLACEBO_COMPARATOR | Induction treatment with placebo plus atezolizumab and CE will be administered on a 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with placebo plus atezolizumab for 21-day cycles |
| Arm A: Tiragolumab + Atezolizumab | EXPERIMENTAL | Participants will receive atezolizumab followed by tiragolumab. |
| Arm B: Tiragolumab Placebo + Atezolizumab | EXPERIMENTAL | Participants will receive atezolizumab followed by tiragolumab matching placebo. |
| Arm C: Tiragolumab Placebo + Atezolizumab Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebos to tiragolumab and atezolizumab. |
| Placebo + Atezolizumab + CE | ACTIVE_COMPARATOR | Participants will receive atezolizumab on Day 1 of each 21-day cycle followed by placebo on Day 1 of each 21-day cycle. Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles. Participants will also receive etoposide on Days 2 and 3. |
| Tiragolumab + Atezolizumab + CE | EXPERIMENTAL | Participants will receive atezolizumab on Day 1 of each 21-day cycle followed by tiragolumab on Day 1 of each 21-day cycle. Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles. Participants will also receive etoposide on Days 2 and 3. |
| Tiragolumab and atezolizumab | EXPERIMENTAL | Tiragolumab 600mg and atezolizumab 1200 mg, both every three weeks |
| Tiragolumab and ipilimumab | EXPERIMENTAL | Tiragolumab 600mg every 3 weeks and ipilimumab 1mg/kg every 3 weeks for the first 4 cycles |
| Tiragolumab, atezolizumab and ipilimumab | EXPERIMENTAL | Tiragolumab 600mg and atezolizumab 1200mg both every 3 weeks, plus ipilimumab 1mg/kg every 3 weeks for the first 4 cycles |
| Tiragolumab and Atezolizumab IV FDC | EXPERIMENTAL | Participants will receive tiragolumab and atezolizumab as an intravenous fixed dose combination (IV FDC) on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity. |
| Tiragolumab plus atezolizumab and bevacizumab | EXPERIMENTAL | Tiragolumab 600mg IV will be administered together with atezolizumab 1200mg IV and bevacizumab 15mg/kg IV every 3 weeks (q3w) until progressive disease or unacceptable toxicity. |
| Tiragolumab+Atezolizumab+Pemetrexed+Carboplatin or Cisplatin | EXPERIMENTAL | Induction treatment with tiragolumab in combination with atezolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with tiragolumab in combination with atezolizumab and pemetrexed on Day 1 of each 21-day cycle. |
| Placebo+Pembrolizumab+Pemetrexed+Carboplatin or Cisplatin | PLACEBO_COMPARATOR | Induction treatment with placebo in combination with pembrolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with placebo in combination with pembrolizumab and pemetrexed on Day 1 of each 21-day cycle. |
| Tiragolumab plus Atezolizumab | EXPERIMENTAL | Participants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator. |
| Atezolizumab | EXPERIMENTAL | Participants will receive atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit as determined by the investigator. |
| Cohort A: Tiragolumab and Atezolizumab + Nab-paclitaxel | EXPERIMENTAL | Participants with first-line metastatic TNBC will receive tiragolumab and atezolizumab on Day 1 of every 28-day cycle plus nab-paclitaxel on Days 1, 8, and 15 of every 28-day cycle. |
| Cohort B: Tiragolumab and Atezolizumab + Nab-pac-carbo-AC | EXPERIMENTAL | Participants with early TNBC in the neoadjuvant setting, who are eligible for surgery, will receive tiragolumab and atezolizumab every 2 weeks (Q2W) in combination with nab-paclitaxel weekly (QW) and carboplatin every 3 weeks (Q3W) for four cycles, followed by tiragolumab and atezolizumab in combination with doxorubicin and cyclophosphamide Q2W with granulocyte colony-stimulating factor (G-CSF; filgrastim or pegfilgrastim) or granulocyte-macrophage colony-stimulating factor (GM-CSF) support for four doses. |
| Cohort B: Tiragolumab and Atezolizumab + Nab-pac-AC | EXPERIMENTAL | Participantswith early TNBC in the neoadjuvant setting, who are eligible for surgery, will receive tiragolumab and atezolizumab Q2W in combination with nab-paclitaxel QW for 12 weeks, followed by tiragolumab and atezolizumab in combination with doxorubicin and cyclophosphamide Q2W with G-CSF (filgrastim or pegfilgrastim) or GM-CSF support for four doses. |
| Name | Type | Description |
|---|---|---|
| Tiragolumab | DRUG | Tiragolumab at a fixed dose of 600 milligrams (mg), administered by intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle. |
| Atezolizumab | DRUG | Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle. |
| Carboplatin | DRUG | Carboplatin administered IV to achieve an initial target area under the concentration time curve (AUC) of 5 mg/mL/min, Q3W on Day 1 of each 21-day cycle for 4 cycles. |
| Etoposide | DRUG | Etoposide 100 mg/m\^2, administered by IV infusion, Q3W on Day 1, 2 and 3 of each 21-day cycle for 4 cycles. |
| Tiragolumab Matching Placebo | DRUG | Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle. |
| Atezolizumab Matching Placebo | DRUG | Atezolizumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle. |
| Placebo | DRUG | Placebo administered by IV infusion on Day 1 of each 21-day cycle. |
| Ipilimumab | DRUG | 1 mg/kg, maximum of 4 cycles |
| Tiragolumab and Atezolizumab IV FDC | DRUG | Intravenous fixed dose combination (IV FDC) of tiragolumab 600 mg and atezolizumab 1200 mg once every 3 weeks (Q3W). |
| Bevacizumab | DRUG | 15mg/kg IV administered every 3 weeks. |
| Pemetrexed | DRUG | Pemetrexed 500 milligrams per square meter (mg/m\^2), administered by IV infusion, Q3W on Day 1 of each 21-day cycle. |
| Cisplatin | DRUG | Cisplatin 75 mg/m\^2, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles. |
| Pembrolizumab | DRUG | Pembrolizumab at a fixed dose of 200 mg, administered by IV infusion, Q3W, on Day 1 of each 21-day cycle. |
| Nab-paclitaxel | DRUG | Nab-paclitaxel 100 milligrams per square meter (mg/m\^2) administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
| Doxorubicin | DRUG | Doxorubicin 60 mg/m\^2 Q2W administered by IV infusion. |
| Cyclophosphamide | DRUG | Cyclophosphamide 600 mg/m\^2 Q2W administered by IV infusion. |
| Granulocyte colony-stimulating factor (G-CSF) | DRUG | G-CSF support for four doses. |
| Granulocyte-macrophage colony-stimulating factor (GM-CSF) | DRUG | GM-CSF support for four doses. |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Histologically or cytologically confirmed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) per the modified Veterans Administration Lung Study Group (VALG) staging system * No prior systemic treatment for...
Tiragolumab is an investigational monoclonal antibody being developed by Roche Holding AG (ticker RHHBY) for the treatment of several cancer types. It is designed to bind the TIGIT immune checkpoint and is being studied in solid tumors including non-small cell lung cancer, cervical cancer, esophageal squamous cell carcinoma, and metastatic breast cancer.
Tiragolumab targets TIGIT, an immune checkpoint receptor. It is classified as a TIGIT inhibitor. By binding TIGIT, the antibody is intended to interfere with an inhibitory signaling pathway in immune cells, which is the mechanism under investigation across the oncology indications where the drug is being studied.
Tiragolumab is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is running the clinical program for the antibody, including studies that combine it with atezolizumab, and the intravenous fixed-dose combination of tiragolumab and atezolizumab is part of that development effort.
Tiragolumab is in Phase 2 development and is investigational. It has not been established as an approved therapy. The program includes Phase 2 studies in metastatic breast cancer and PD-L1-selected solid tumors, along with a Phase 3 study in extensive-stage small cell lung cancer.
Tiragolumab is being studied in several trials. NCT06342037 is a recruiting Phase 2 trial in metastatic breast cancer in the Netherlands. NCT05661578 is a completed Phase 2 study of the intravenous fixed-dose combination with atezolizumab in PD-L1-selected solid tumors. NCT04958811 is an active Phase 2 trial in non-squamous NSCLC, and NCT04665856 is a completed Phase 3 study in small cell lung cancer.