Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SC16LD6.5, Rova-T
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 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Amgen Inc. | AMGN | 1 | PHASE3 | Tarlatamab |
Rovalpituzumab tesirine is an investigational antibody-drug conjugate developed by AbbVie Inc. (ticker: ABBV) for the treatment of cancer, specifically small cell lung cancer. It is designed to deliver a cytotoxic payload to tumor cells. The drug has been studied in clinical trials but is not approved for any indication.
Rovalpituzumab tesirine targets DLL3 (Delta-like protein 3), a protein expressed on the surface of small cell lung cancer cells. By binding to DLL3, the antibody-drug conjugate delivers a cytotoxic agent directly to tumor cells, potentially reducing damage to normal tissues.
Rovalpituzumab tesirine is being developed by AbbVie Inc., a biopharmaceutical company traded under the ticker symbol ABBV. AbbVie acquired the drug through its acquisition of Stemcentrx in 2016. The company has conducted multiple clinical trials to evaluate its safety and efficacy.
Rovalpituzumab tesirine is in Phase 2 development, with additional Phase 1 and Phase 3 trials completed. It remains an investigational therapy and has not been approved by the FDA for any indication. The clinical program includes studies in small cell lung cancer and other cancers.
Rovalpituzumab tesirine has been evaluated in several clinical trials, including NCT03543358 (Phase 2 long-term study), NCT03086239 (Phase 1 in Japanese patients), NCT03061812 (Phase 3 TAHOE study), and NCT02674568 (Phase 2 third-line study). All trials are completed, with no active trials currently.
Yes, SC16LD6.5 is an alternative name for rovalpituzumab tesirine. It is an antibody-drug conjugate that targets DLL3 and is being developed by AbbVie Inc. for small cell lung cancer and other cancers. The drug is investigational and has not received regulatory approval.