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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G1 Therapeutics to Evaluate Trilaciclib (G1T28) in Combination with Immune Checkpoint Inhibitor in Small-Cell Lung Cancer

Excerpt:

“G1 Therapeutics, Inc., a clinical-stage oncology company, announced today a clinical trial collaboration with Genentech, a member of the Roche Group. A Phase 2 clinical trial is expected to begin in the first half of 2017 and will evaluate the combination of Genentech’s immune checkpoint, anti-PD-L1 antibody Tecentriq® (atezolizumab) with G1’s CDK4/6 inhibitor trilaciclib (G1T28) as a first-line treatment for patients with small-cell lung cancer (SCLC) receiving chemotherapy.”

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Marine Drug Goes to Phase III Trials to Treat Lung Cancer

Excerpt:

“PharmaMar is starting a new Phase III trial, with patients suffering from small cell lung cancer (SCLC). It’ll test the efficacy of its third candidate obtained from marine organisms (PM1183) as a SCLC treatment.

“PharmaMar is one of the hot Biotechs in Spain, which just saw its second drug finish Phase III trials with good results (and is already in trials for other indications, as we’ve seen at ASCO).

“Now, PM1183 is under the spotlight. This cancer drug will be used in a second Phase III trial (after ovarian cancer). It’ll enrol 600 patients with small cell lung cancer (SCLC), for whom platinum-based treatments have failed before.”

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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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Lung Cancer Highlights from ASCO 2016


This year, the Annual Meeting of the American Society of Clinical Oncology (ASCO) did not produce any truly groundbreaking revelations about new treatments for lung cancer. However, researchers did report quite a few positive findings, and some disappointing ones. I have summarized some of the more prominent presentations below. Continue reading…


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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ASCO 2016: Nivolumab Alone or in Combination With Ipilimumab Active in Recurrent Small Cell Lung Cancer

Excerpt:

“A study presented by Antonia et al at the 2016 ASCO Annual Meeting (Abstract 100) showed that utilizing the immunotherapeutic agents nivolumab (Opdivo) and ipilimumab (Yervoy) could lead to more effective treatment options for patients with small cell lung cancer (SCLC) who have progressed after prior chemotherapy.

“Studies have shown that nivolumab combined with ipilimumab results in improved antitumor activity when compared with either agent alone. The U.S. Food and Drug Administration recently approved this two-drug combination for the treatment of advanced melanoma.

“Given the promising activity of the immunotherapy combination in melanoma, researchers wanted to assess whether this regimen could also be effective in other types of tumors with few to no therapeutic options.”

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Expert Examines Immunotherapy Potential in Small Cell Lung Cancer

Excerpt:

“Several ongoing clinical trials are examining the efficacy and safety of immunotherapy agents in patients with small cell lung cancer (SCLC), explains David P. Carbone, MD, PhD.

“Two early phase studies have already shown encouraging results. In the phase I/II CheckMate-032 trial, pretreated patients with SCLC received monotherapy with the PD-1 inhibitor nivolumab (Opdivo) or the combination of nivolumab plus the CTLA-4 inhibitor ipilimumab (Yervoy). Data showed that the median progression-free survival (PFS) was 3.35 months with the combination and 1.38 months with nivolumab alone. Median OS was 7.75 months with the combination and 3.55 months with single-agent therapy. The objective response rate (ORR) with the combination was 31.1%.

“In the phase Ib KEYNOTE-028 trial, the PD-1 inhibitor pembrolizumab (Keytruda) had an ORR of 29.2% (95% CI, 12.6-51.1) in patients with SCLC who had prior chemotherapy.”

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Study Shows Statins Could Be Effective against Small Cell Lung Cancer

“In a recent study, researchers at Cancer Treatment Centers of America (CTCA) at Western Regional Medical Center (Western), in collaboration with international colleagues, found that statins could be an effective therapeutic against metastatic small cell lung cancer (SCLC).

“The study of 876 late-stage SCLC patients, published today in the peer-reviewed scientific journal PLOS ONE, showed that statins, a class of drugs primarily used to lower cholesterol in patients at risk for heart disease, appeared to provide an increase in overall survival for those cancer patients who received them.

” ‘Small cell lung cancer is one of the most aggressive types of cancer, and yet in nearly three decades, no new classes of treatments have been adopted as new benchmarks for standard therapy,’ said Dr. Glen Weiss, M.D., M.B.A., Director of Clinical Research and Medical Oncologist at CTCA at Western in Goodyear, Ariz., and the study’s senior author. ‘Our study showed that statins appear to provide a statistically significant survival benefit among patients with metastatic SCLC.’ “