On June 5, 2016 AbbVie (NYSE: ABBV), a global biopharmaceutical company, reported that treatment with rovalpituzumab tesirine (Rova-T), a delta-like protein 3 (DLL3)-targeted antibody-drug conjugate (ADC), demonstrated a confirmed overall response rate (ORR) of 39 percent and clinical benefit rate (stable disease or better) of 89 percent in patients with recurrent or refractory small cell lung cancer (SCLC), identified with high expression of DLL3 (Press release, AbbVie, JUN 5, 2016, View Source [SID:1234513030]). Rova-T demonstrated a one-year overall survival (OS) rate of 32 percent in the recurrent/refractory second- and third-line patient population. These new data were presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago and featured in the "Best of ASCO (Free ASCO Whitepaper)" program, which presents scientific and educational highlights from the meeting. Less than one percent of all data abstracts are selected for this program.

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In the trial, the most common treatment-emergent adverse events were fatigue (35 percent), pleural effusion (31 percent), edema peripheral (27 percent), nausea (19 percent), hypoalbuminemia (18 percent), thrombocytopenia, rash maculo-papular and decreased appetite (16 percent each). Grade three and higher severe toxicities were thrombocytopenia (11 percent), pleural effusion (8 percent), fatigue (4 percent), edema peripheral, and rash maculo-papular (3 percent each).

"These data further contribute to our understanding of the potential impact that treatment with Rova-T, a predictive biomarker-based therapy, could have on pretreated small cell lung cancer patients identified as high expressers of DLL3," said Charles M. Rudin, M.D., Ph.D., Chief of the Thoracic Oncology Service at Memorial Sloan Kettering. "The results presented at ASCO (Free ASCO Whitepaper) support further clinical development of this compound."

Small cell lung cancer (SCLC) is an aggressive, difficult-to-treat form of cancer that accounts for roughly 13-15 percent of all lung cancers.1,2 The five year survival rate for extensive-stage SCLC remains at less than 5 percent3 and there are limited treatment options available for the more than 234,000 people diagnosed with SCLC annually.1,2,4 Treatment options for patients remain limited, with chemotherapy and radiation being the most common forms of first- and second-line treatment.5

"Due to the aggressive nature of small cell lung cancer, there are limited treatment options available, resulting in a typically poor prognosis for most patients," said Mike Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "Rova-T represents a potential new approach to treating this disease by targeting DLL3, a protein that is expressed in the majority of small cell lung cancer patients. We are committed to further developing this compound and look forward to the possibility of delivering it to patients in need of new treatment options."

About the Phase 1a/1b Trial
This Phase 1a/1b, multicenter, open label, dose escalation trial was designed to assess the safety, pharmacokinetics, and preliminary efficacy of rovalpituzumab tesirine (Rova-T) as monotherapy in patients with recurrent small cell lung cancer (SCLC). The trial enrolled 74 patients, all of whom had failed at least one prior standard therapy. The primary objectives were maximum tolerated dose and an overall response rate (ORR), assessed by Response Evaluation Criteria In Solid Tumors (RECIST). Secondary objectives included pharmacokinetics and RECIST-assessed progression-free survival (PFS) and overall survival (OS). As well, the clinical benefit rate (stable disease or better) was assessed by RECIST.

About Rovalpituzumab Tesirine (Rova-T)
Rova-T is an investigational antibody-drug conjugate targeting the cancer-stem cell-associated delta-like protein 3 (DLL3)6, which is expressed in more than 80 percent of small cell lung cancer (SCLC) patient tumors, where it is prevalent on tumor cells, including cancer stem cells, but not present in healthy tissue.7 Rova-T combines a targeted antibody that delivers a cytotoxic agent directly to the DLL3-expressing cancer cells while minimizing toxicity to healthy cells. Rova-T is under investigation as a third-line treatment in SCLC.7 Studies designed to select a Rova-T regimen for first-line registration will be starting soon.8 The expression of DLL3 suggests Rova-T may be useful across multiple tumor types, including metastatic melanoma, glioblastoma multiforme and some prostate, pancreatic and colorectal cancers.7

Rova-T is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority.