Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD5335, Torvu-sam
Torvutatug samrotecan · 5 trials · 10 indications
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review, or death due to any cause.
PFS is defined as the time from randomization to radiographic progression as assessed by BICR per RECIST v1.1, or death due to any cause.
The effect of itraconazole on the pharmacokinetics (PK) of AZ14170132 will be assessed.
The effect of itraconazole on the PK of AZ14170132 will be assessed.
Number of participants with incidence of adverse events and with serious adverse events including changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination.
A DLT is defined as any ≥ Grade 3 treatment-emergent AE that occurs during the DLT evaluation period, not attributable to the underlying disease or extraneous causes (as defined in the protocol)
| Arm | Type | Description |
|---|---|---|
| Torvutatug samrotecan monotherapy or in combination with bevacizumab | EXPERIMENTAL | Torvutatug samrotecan monotherapy intravenous (IV) or Torvutatug samrotecan IV with bevacizumab IV. |
| Observation or bevacizumab | ACTIVE_COMPARATOR | Observation or bevacizumab IV. |
| Torvutatug samrotecan + Bevacizumab | EXPERIMENTAL | Torvutatug samrotecan IV (intravenous) + Bevacizumab IV |
| Bevacizumab | ACTIVE_COMPARATOR | Bevacizumab IV |
| AZD5335 in FRa-high cohort | EXPERIMENTAL | AZD5335 IV (intravenous) in FRa-high cohort |
| Mirvetuximab Soravtansine (MIRV) in FRa-high cohort | ACTIVE_COMPARATOR | MIRV AIBW IV in FRa-high cohort |
| AZD5335 in FRa-low cohort | EXPERIMENTAL | AZD5335 IV (intravenous) in FRa-low cohort |
| Investigator´s choice chemotherapy in FRa-low cohort | ACTIVE_COMPARATOR | Investigator's choice of chemotherapy Paclitaxel IV Pegylated liposomal Doxorubicin (PLD) IV or Topotecan IV in FRa-low cohor |
| AZD5335/AZD5335 + Itraconazole | EXPERIMENTAL | In Part A, participants will receive AZD5335 alone as an intravenous (IV) infusion, and in combination with oral itraconazole, every 3 weeks (Q3W) from cycle 1 to cycle 3. In Part B, participants will receive AZD5335 as an IV infusion Q3W, from Day 1 of Cycle 4 until progression, unacceptable toxicity or any other specified criteria for discontinuation occurs. |
| Module 1: Torvu-sam Monotherapy | EXPERIMENTAL | Torvu-sam Monotherapy |
| Module 2: Torvu-sam + Saruparib | EXPERIMENTAL | Torvu-sam + Saruparib |
| Module 3: Torvu-sam + Bevacizumab | EXPERIMENTAL | Torvu-sam + Bevacizumab |
| Module 4: Torvu-sam + Carboplatin +/- Bevacizumab | EXPERIMENTAL | Torvu-sam + Carboplatin +/- Bevacizumab |
| Module 5: Torvu-sam + Palacaparib +/- Bevacizumab | EXPERIMENTAL | Torvu-sam + Palacaparib +/- Bevacizumab |
| Module 6: Torvu-sam + Pembrolizumab +/- Palacaparib | EXPERIMENTAL | Torvu-sam + Pembrolizumab +/- Palacaparib |
| Name | Type | Description |
|---|---|---|
| Torvutatug samrotecan | DRUG | FRa targeting antibody drug conjugate Topoisomerase I inhibitor |
| Bevacizumab | DRUG | Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor |
| AZD5335 | DRUG | antibody drug conjugate |
| Mirvetuximab Soravtansine (MIRV) | DRUG | antibody drug conjugate |
| Paclitaxel | DRUG | chemotherapy |
| Pegylated liposomal Doxorubicin (PLD) | DRUG | chemotherapy |
| Topotecan | DRUG | chemotherapy |
| Itraconazole | DRUG | Itraconazole capsule will be administered orally. |
| Saruparib | DRUG | Oral PARP inhibitor |
| Carboplatin | DRUG | IV Alkylating agent |
| Palacaparib | DRUG | Oral PARP inhibitor |
| Pembrolizumab | DRUG | IV Biologic |
Inclusion Criteria: * Participants with confirmed histology of high-grade epithelial serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer. * Provision of an archival FFPE tumour sample * Participants who received at least one, and no more than 2 lines of prior systemic antic...
Torvutatug samrotecan is being developed for epithelial ovarian cancer, including platinum-sensitive relapsed epithelial ovarian cancer. AstraZeneca is studying it as first-line maintenance in HRD-negative advanced disease and as maintenance treatment in the platinum-sensitive relapsed setting, both in Phase 3 trials.
Torvutatug samrotecan is developed by AstraZeneca PLC, which trades on Nasdaq under the ticker AZN. AstraZeneca is running the Phase 3 ovarian cancer program and the earlier Phase 1/2a solid tumor study of the asset.
Torvutatug samrotecan is in Phase 3 development. Two Phase 3 trials are recruiting in epithelial ovarian cancer, and an earlier Phase 1/2a solid tumor study is also recruiting. It is investigational and has not been approved by the FDA for any indication.
Torvutatug samrotecan is in NCT07851025, a Phase 3 first-line maintenance study in HRD-negative advanced epithelial ovarian cancer with 950 patients, and NCT07816666, a Phase 3 maintenance study in platinum-sensitive relapsed ovarian cancer with 600 patients. A Phase 1/2a solid tumor study, NCT05797168, is also recruiting.
Yes, AZD5335 is an earlier designation for torvutatug samrotecan. The Phase 1/2a solid tumor study NCT05797168 is listed under the AZD5335 name, while the Phase 3 ovarian cancer trials use torvutatug samrotecan. Both refer to the same AstraZeneca asset.
Yes, the Phase 3 first-line maintenance trial NCT07851025 enrolls patients with homologous recombination deficiency negative advanced epithelial ovarian cancer, so enrollment is defined by HRD status. The platinum-sensitive relapsed study NCT07816666 evaluates the drug with or without bevacizumab as maintenance treatment.