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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New Promising Drugs for Small Cell Lung Cancer


Any type of advanced lung cancer is bad news, but a diagnosis of small cell lung cancer (SCLC) is a particularly grim one to receive. About 30 years have passed since any new treatments for SCLC were developed, and patients’ responses to standard chemotherapy with etoposide and cisplatin are short-lived. Hopefully, this will change soon.

We begin this post with the immune checkpoint inhibitors, a type of immunotherapy that is explored in seemingly every type of cancer, including SCLC. Reports from two clinical trials of these drugs were recently made available at two meetings on lung cancer treatment. Continue reading…


Cancer Stem Cells and How to Get Rid of Them


If you have not yet heard of cancer stem cells (CSCs), often considered to be the real culprits in cancer, it is about time you do. CSCs are stem cells found in tumors. Drugs that target them are showing promise in clinical trials. More on that later; first, let’s introduce the concept of stem cells:

All normal tissues in our bodies develop from a small number of very special cells known as stem cells. Stem cells can divide a seemingly unlimited number of times. Continue reading…


First 'Targeted' Treatment for Small Cell Lung Cancer Shows Promise

“Small cell lung cancer (SCLC) is an aggressive disease that is difficult to treat and is frequently only diagnosed when it has spread to other parts of the body (metastasised). Five-year survival rates in SCLC, which accounts for about 14% of all lung cancers, are very low, at only six percent. But today US researchers will present two novel findings with important implications for treatment at the 2015 European Cancer Congress.

“Dr M. Catherine Pietanza, MD, an Assistant Attending Physician at the Memorial Sloan Kettering Cancer Center, New York, USA, will report on results from a phase I trial of a novel agent, rovalpituzumab tesirine (Rova-T, or S16LD6.5), in 79 patients with SCLC who had progressed after first line (given when the disease is newly diagnosed) or second line therapy (given when the disease progresses or recurs).

” ‘While other cancers have multiple treatment options, there is only one agent approved in SCLC, and none available in the third line setting; the outlook for these patients is dismal,’ she will say. Third line therapy is given after first and second line treatments have failed to halt the progression of disease.”