Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rovalpituzumab tesirine · 4 trials · 2 indications
OS is defined as the time from the date of randomization to the date of death from any cause. Participants were censored at the last date they were documented alive. After the End of treatment, survival information was collected at approximately 6-week intervals (or as requested by sponsor to support data analysis) continuing until the endpoint of death, the participant became lost to follow-up, AbbVie terminated the study, or until 12 February 2020. Calculated using the Kaplan-Meier product-limit method.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either a reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. TEAEs and serious TEAEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on AEs, please see the Adverse Event section.
Objective response is defined as a participant with the best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, prior to receiving any subsequent anticancer therapy and retreatment, and is confirmed by a consecutive response assessment at least 4 weeks (28 days) from the initial determination of CR/PR. Analyzed based on response assessments from both the Independent Review Committee (IRC) and investigators. CR: disappearance of all target lesions.Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Overall survival is defined as the time from the first dose date to death for any reason. Participants who were alive at the clinical data cut-off were censored at the last known alive date. Based on Kaplan-Meier estimates.
DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
| Arm | Type | Description |
|---|---|---|
| Rovalpituzumab tesirine | EXPERIMENTAL | Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted. Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered. |
| Topotecan | ACTIVE_COMPARATOR | Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m\^2 on Days 1 to 5 of each 21-day cycle. |
| Arm A: Post-Treatment Follow-Up/Optional Retreatment | EXPERIMENTAL | Arm A includes participants who enter the extension study while in post-treatment follow-up. This arm includes optional rovalpituzumab tesirine retreatment plus dexamethasone per participant per retreatment period. |
| Arm B: Continued Treatment | EXPERIMENTAL | Arm B includes participants who enter the extension study while receiving ongoing rovalpituzumab tesirine treatment plus dexamethasone in the parent study. |
| Part A: Rovalpituzumab tesirine | EXPERIMENTAL | Part A Dose Escalation: Rovalpituzumab tesirine intravenous (IV) (various doses and dose regimens) on Day 1 of each 6-week cycle |
| Part B: Rovalpituzumab tesirine | EXPERIMENTAL | Part B Dose Expansion: Rovalpituzumab tesirine dosed at regimen(s) previously demonstrated in Part A to not to exceed the maximum tolerated dose (MTD). |
| Name | Type | Description |
|---|---|---|
| Rovalpituzumab tesirine | DRUG | Powder for solution for infusion in vials. |
| Topotecan | DRUG | Powder or solution for infusion in vials. Topotecan is commercially available as both a powder and solution for infusion. Availability will vary by region. |
| Dexamethasone | DRUG | Oral tablet. |
Inclusion Criteria: * Participant must have histologically or cytologically confirmed advanced or metastatic Small Cell Lung Cancer (SCLC) with documented first disease progression during or following front-line platinum-based systemic regimen * Tumor must have high Delta-like protein 3 (DLL3) expr...
Top 20 of 84 competitors
Rovalpituzumab tesirine is an investigational oncology drug being studied for the treatment of small cell lung cancer and other cancers. It is being developed by AbbVie Inc. (ABBV) and has been evaluated in clinical trials for patients with relapsed or refractory small cell lung cancer expressing delta-like protein 3 (DLL3).
Rovalpituzumab tesirine targets delta-like protein 3 (DLL3), a protein expressed in small cell lung cancer cells. The drug is designed to bind to DLL3 and deliver a cytotoxic agent to cancer cells. This mechanism is being studied in patients with DLL3-expressing tumors.
Rovalpituzumab tesirine is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. AbbVie is conducting clinical trials to evaluate the drug's safety and efficacy in small cell lung cancer.
Rovalpituzumab tesirine has completed Phase 1, Phase 2, and Phase 3 clinical trials. The Phase 3 trial, known as TAHOE, compared the drug to topotecan in patients with advanced small cell lung cancer. However, the drug is not approved and remains investigational.
Rovalpituzumab tesirine has been studied in three completed clinical trials: NCT02674568 (Phase 2, third-line treatment of DLL3-expressing small cell lung cancer), NCT03061812 (Phase 3 TAHOE study versus topotecan), and NCT03086239 (Phase 1, Japanese patients with advanced small cell lung cancer). All trials are completed.
Yes, Rovalpituzumab tesirine is also known as SC16LD6.5. The Phase 2 clinical trial NCT02674568, which studied the drug for third-line treatment of relapsed or refractory small cell lung cancer, used the name SC16LD6.5 in its title.