Clinical Trials

Date: 2018-03-22

Type of information: Results

phase: 2

Announcement: initiation of the trial

Company: Stemcentrx (USA - CA), now AbbVie (USA - IL)

Product: rovalpituzumab tesirine (Rova-T)

Action mechanism:

antibody drug conjugate. Rova-T (rovalpituzumab tesirine) is an antibody drug conjugate (ADC) targeting delta-like protein 3 (DLL3). This protein is present at high levels in small cell lung cancer and other neuroendocrine tumor cells.

Disease: relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer (SCLC)

Therapeutic area: Cancer - Oncology - Rare diseases

Country: USA

Trial details:

This open-label, single-arm, phase 2 study (TRINITY) is evaluating the efficacy, safety and pharmacokinetics of rovalpituzumab tesirine (Rova-T - SC16LD6.5) for third-line and later treatment of subjects with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer (SCLC). The purpose of this study is to determine the efficacy of rovalpituzumab tesirine as a third-line and later treatment for subjects with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer (SCLC). (NCT02674568)

Latest news:

• On March 22, 2018, AbbVie announced that after consulting with the FDA, it will not seek accelerated approval for Rova-T in third-line relapsed/refractory (R/R) small cell lung cancer (SCLC) based on magnitude of effect across multiple parameters in this single-arm study. Ongoing Phase 3 studies, MERU and TAHOE, will continue to investigate Rova-T in first- and second-line SCLC Full data have been submitted to the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting.
Summary of Investigator Assessed Best Overall Response Rate, Independent Review Committee (IRC) Assessed Objective Response Rate, Duration of Response and Overall Survival in Third-Line SCLC Patients with High DLL3 Expression (N = 177)*

	DLL3 High 3L (N = 177)
Investigator Assessed Outcome
Best Overall Response Rate^a (95% CI)	29% (22%, 36%)
IRC Assessed Outcomes
Objective Response Rate (by RECIST criteria – v1.1)^b (95% CI)	16% (11%, 22%)
Duration of Objective Response (months) Median (months) (95% CI)	4.1 (3.0, 4.2)
Overall Survival
Median (months) (95% CI)	5.6 (4.9, 6.8)
Probability of Subjects Alive at 12 months (95% CI)^c	17.5% (10.8%, 25.5%)

*Data represent 74 percent of the TRINITY study population with high DLL3 expression
a Best overall response is defined as a subject with a response of complete response (CR) or partial response (PR) at any time prior to receiving any subsequent anticancer therapy.
b Objective response is defined as a subject with a response of complete response (CR) or partial response (PR) prior to receiving any subsequent anticancer therapy, with confirmation of CR or PR at least 4 weeks (28 days) from the initial determination per RECIST v1.1.
c Based on Kaplan-Meier estimate.
In the study, the most common treatment-emergent adverse events were fatigue (38 percent), photosensitivity reaction (36 percent), pleural effusion (32 percent), edema peripheral (31 percent), decreased appetite (30 percent), nausea (26 percent), dyspnea (25 percent), thrombocytopenia (25 percent), constipation (22 percent), vomiting (17 percent), anemia (17 percent), hypoalbuminemia (16 percent), and cough (16 percent). Grade three and higher severe toxicities ? 5 percent were thrombocytopenia (11 percent), photosensitivity reaction (7 percent) and pleural effusion (5 percent).