Rovalpituzumab Tesirine Active and Safe in Small Cell Lung Cancer

Excerpt:

“Rovalpituzumab tesirine (Rova-T), a DLL3-targeted antibody-drug conjugate, demonstrated encouraging single-agent antitumor activity with a manageable safety profile in the treatment of patients with recurrent small cell lung cancer (SCLC), according to the results of a phase I study published in The Lancet Oncology.

“Eleven of 60 assessable patients (18%) who received an active dose of Rova-T (0.2 mg/kg or 0.4 mg/kg every 3 weeks or 0.3 mg/kg or 0.4 mg/kg every 6 weeks) achieved a confirmed objective response, and 30 patients (50%) had stable disease. The median progression-free survival (PFS) was 2.8 months (95% CI, 2.5-4.0).”

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Novel Combination Study Planned for SCLC

Excerpt:

“A phase I/II study will explore the delta-like protein 3 (DLL3)-targeted antibody-drug conjugate rovalpituzumab tesirine (Rova-T) with the PD-1 inhibitor nivolumab (Opdivo) alone or in combination with the CTLA-4 inhibitor ipilimumab (Yervoy) for patients with relapsed extensive-stage small cell lung cancer (SCLC).

“AbbVie, the developer of rovalpituzumab tesirine, and Bristol-Myers Squibb, the company marketing nivolumab and ipilimumab announced the phase I/II study in a joint press release. As single-agents, rovalpituzumab tesirine and nivolumab have each demonstrated promising early findings for patients with SCLC. Additionally, nivolumab plus ipilimumab sparked promising response rates and overall survival (OS) findings. Data for the 3 agents were recently presented at the 2016 ASCO Annual Meeting.”

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AbbVie Shares Fall on Low Survival Data for Lung Cancer Drug

Excerpt:

“AbbVie Inc.’s shares fell Monday after an early trial showed patients taking the company’s experimental lung cancer drug survived fewer months than typical of those on chemotherapy, raising questions as to whether the company was right to buy the medicine in a $5.8 billion deal.

“AbbVie’s drug is known as Rova-T. In patients with an aggressive form of lung cancer who expressed more of the protein marker known as DLL3 that’s targeted by the drug, median survival was 5.8 months, according to data presented Sunday at the annual meeting of the American Society for Clinical Oncology in Chicago. With the only approved drug for recurrent disease, a form of chemotherapy called topotecan, median overall survival is about seven months, according to Tony Butler, an analyst at Guggenheim Partners.

“Rova-T’s initial survival data could be a disappointment to investors, Barclays analyst Geoff Meacham said in a note to clients. AbbVie’s shares dropped 4 percent to $62.42 at 10:32 a.m. in New York.”

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ASCO 2016: New Antibody-Drug Conjugate Shows Early Promise in Small Cell Lung Cancer

Excerpt:

“Early findings from a first-in-human clinical trial showed that the antibody-drug conjugate rovalpituzumab tesirine (Rova-T) shows promising efficacy against recurrent small cell lung cancer (SCLC). The treatment, which combines a novel anti-DLL3 antibody with a powerful anticancer agent, halted tumor growth in 89% of patients with high levels of DLL3 in the tumor and shrank tumors in 39%.

“The study by Rudin et al was presented today at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA8505).

“ ‘We’ve seen too few successes in recent years for small cell lung cancer, which makes these early signs of efficacy all the more encouraging,’ said lead study author Charles M. Rudin, MD, PhD, a medical oncologist and Chief of Thoracic Oncology Service at Memorial Sloan Kettering Cancer Center in New York. ‘Although these results are preliminary, rovalpituzumab tesirine seems to be the first targeted therapy to show efficacy in small cell lung cancer, and we may have identified DLL3 as the first predictive biomarker in this disease.’ ”

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