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Answering an urgent need
July 2016
by Ilene Schneider  |  Email the author
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NORTH CHICAGO, Ill.—Small cell lung cancer (SCLC), which is aggressive and difficult to treat, accounts for 13 to 15 percent of all lung cancers. The five-year survival rate for extensive-stage SCLC remains at less than 5 percent, and there are limited treatment options available for the more than 234,000 people diagnosed with SCLC annually. Chemotherapy and radiation are the most common forms of first- and second-line treatment, creating an urgent need for effective therapies.
 
GlobalData, a research and consulting firm, has estimated that the SCLC market across the seven major markets of the United States, France, Germany, Italy, Spain, the United Kingdom and Japan was worth $198 million in 2014 and will expand rapidly to reach $2.29 billion by 2024. Recent data from the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting have shown that rovalpituzumab tesirine (Rova-T), AbbVie’s antibody-drug conjugate (ADC) to treat recurrent/refractory SCLC, represents a promising new approach, as it is the first biomarker-directed therapy for treating the disease, according to an analyst from GlobalData.
 
The experimental “smart-bomb” drug Rova-T appears safe and shows efficacy in treating patients with advanced SCLC, according to results from a first-in-human clinical trial presented by a Memorial Sloan Kettering Cancer Center (MSKCC) researcher at the ASCO meeting. The findings also show that patients responded better to the drug when their tumors expressed high levels of delta-like protein 3 (DLL3), the protein that Rova-T targets.
 
AbbVie reported that treatment with Rova-T demonstrated a confirmed overall response rate of 39 percent and clinical benefit rate (stable disease or better) of 89 percent in patients with recurrent or refractory SCLC identified with high expression of DLL3. Rova-T demonstrated a one-year overall survival rate of 32 percent in the recurrent/refractory second- and third-line patient population. These new data were featured in the “Best of ASCO” program, which presents scientific and educational highlights from the meeting.
 
“The goal is always to give the right patient the right drug at the right time, but patients with advanced small cell lung cancer have not benefited from any of the new targeted therapies available to patients with other types of cancer,” said Dr. Charles M. Rudin, chief of the Thoracic Oncology Service at MSKCC, who presented the findings at the ASCO meeting. “They desperately need new treatment options, so the ability to predict whether a patient might respond to Rova-T by testing their tumor for overexpression of the DLL3 protein is crucial, because it may ultimately help us give this drug to the patients most likely to benefit from it, and avoid giving it to patients who won’t.”
 
Rudin added, “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. The results presented at ASCO support further clinical development of this compound.”
 
According to Dr. Mike Severino, executive vice president of research and development and chief scientific officer at AbbVie, the “aggressive nature of small cell lung cancer” limits treatment options available, “resulting in a typically poor prognosis for most patients.” Rova-T, he explained, “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.” AbbVie is “committed to further developing this compound” and is looking forward to the possibility of “delivering it to patients in need of new treatment options.”
 
Dr. Volkan Gunduz, a GlobalData analyst covering oncology and hematology, concluded, “By attaching a powerful chemotherapy that is too potent to administer on its own to an antibody that detects delta-like protein 3 (DLL3), Rova-T delivers the payload directly to cancer cells. Importantly, DLL3 is not present in healthy tissue but is expressed in more than 80 percent of SCLC patient tumors, making it a highly specific biomarker for SCLC.”
 
Code: E071616

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