Opdivo Alone or Combined with Yervoy Shows Encouraging Response and Survival Rates in Recurrent Small Cell Lung Cancer Patients with High Tumor Mutation Burden, in Exploratory Analysis from Phase 1/2 Study CheckMate -032

Excerpt:

Bristol-Myers Squibb Company (NYSE:BMY) today announced data evaluating Opdivo (nivolumab) and Opdivo plus Yervoy (ipilimumab) in previously treated small cell lung cancer (SCLC) patients whose tumors were evaluable for tumor mutation burden (TMB), from the Phase 1/2 CheckMate -032 trial. The primary objective of this trial was objective response rate (ORR) as assessed by a blinded independent central review (BICR), for which results were previously presented; in the pooled intent-to-treat (ITT) population (n=401), the ORR was 11% with Opdivo alone and 22% with the combination. Among the ITT population, 211 (53%) patients had an evaluable TMB result for these analyses and were divided into subgroups of high, medium and low levels of TMB.”

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FDA Grants Priority Review to Afatinib for NSCLC With Rare EGFR Mutations

Excerpt:

“The FDA has granted a priority review to a supplemental new drug application (sNDA) for afatinib (Gilotrif) for the frontline treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors harbor EGFR exon 21 (L861Q), G719X, or S768I substitution mutations.

“Uncommon mutations such as these represent less than 10% of the EGFR mutations found in NSCLC patients, but are associated with poor prognosis and survival, Boehringer Ingelheim, the manufacturer of afatinib, noted in a press release.”

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New System Finds and Targets Vulnerabilities in Lung Cancer Cells

Excerpt:

“Genetic changes that help lung cancer thrive also make it vulnerable to a promising experimental drug, according to a study led by researchers from Perlmutter Cancer at NYU Langone Health, and published online October 2 in Nature Medicine.

“Specifically, the study found that mutations in the DNA code for the gene KEAP1 help lung adenocarcinoma  counter a process called oxidative stress, in which molecules known as reactive oxygen species (ROS) are created as a side effect of ‘burning’ fuel to make energy. Cancer cells need extra fuel to support abnormal growth, produce more ROS, and depend more for survival on naturally occurring antioxidants that keep ROS from damaging cell parts.”

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DNA Mutations Shed in Blood Predicts Response to Immunotherapy in Patients With Cancer

Excerpt:

“In a first-of-its-kind study, University of California San Diego School of Medicine researchers report that a blood sample, or liquid biopsy, can reveal which patients will respond to checkpoint inhibitor-based immunotherapies.

” ‘We can help predict response to immunotherapy by measuring the number of mutations in circulating tumor DNA using a simple blood test,’ said Yulian Khagi, MD, UC San Diego Moores Cancer Center fellow and first author. ‘Immunotherapy can result in serious side effects, and therefore being able to predict who will respond is important to mitigating potential risk to each patient.’ ”

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Radiation-Immunotherapy Combination Can Slow Tumor Growth for Some Patients With Metastatic Late-Stage Cancer

Excerpt:

“A new study involving patients with stage IV cancer finds that treatment with radiation therapy and immunotherapy can halt the growth of tumors by stimulating the body’s immune system to attack the cancer. In the phase II trial, patients with end-stage cancer that had spread to the lungs or liver demonstrated a favorable response to the combined treatment. Between 30 and 60 percent of the patients, depending on the treatment arm, found that their cancer stopped spreading. Findings will be presented today at the 59th Annual Meeting of the American Society for Radiation Oncology (ASTRO).”

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Addition of Stereotactic Ablative Radiotherapy to Nivolumab Improves Lung Cancer Survival

Excerpt:

“The combination of stereotactic ablative radiotherapy plus anti-PD-1 therapy improved survival among patients with advanced lung cancer, according to a retrospective analysis presented at the International Association for the Study of Lung Cancer Multidisciplinary Symposium in Thoracic Oncology.

“Immune checkpoint inhibitors have improved outcomes in non-small cell lung cancer. However, the absolute improvement over docetaxel is only 3 to 5 months for median OS and 15% to 20% for overall response rate.”

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Ipilimumab Shows Promise in Mutated NSCLC, but Toxicities May Limit Use

Excerpt:

“The addition of ipilimumab to targeted therapy for the treatment of EGFR- and ALK-mutated non-small cell lung cancer demonstrated improved survival despite dose-dependent toxicities, according to results from a phase 1b trial presented at the International Association for the Study of Lung Cancer Multidisciplinary Symposium in Thoracic Oncology.

“Ipilimumab (Yervoy, Bristol-Myers Squibb), a CTLA-4 inhibitor, has demonstrated long-term responses in patients with melanoma; however, the drug is associated with a high rate of grade 3 and grade 4 immune-related adverse events.”

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Osimertinib Improves Progression-Free Survival in Patients With EGFR Mutated Lung Cancer

Excerpt:

“Osimertinib improves progression-free survival by 54% compared to standard first line therapy in patients with EGFR mutated non-small-cell lung cancer (NSCLC), according to late-breaking results from the FLAURA trial presented today at the ESMO 2017 Congress in Madrid.

“EGFR  are present in around 15% of NSCLC in Western populations, rising to 35% in Asian populations. EGFR inhibitors are superior to chemotherapy in the first line treatment of these patients. However, despite high response rates and good progression-free survival, patients invariably develop  to drugs such as erlotinib and gefitinib. In the majority of patients this resistance is mediated by a T790M mutation.”

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ESMO 2017 Press Release: Combination Immunotherapy in Second/third Line Extends Mesothelioma Survival to 15 Months

Excerpt:

“Combination immunotherapy as second or third line treatment extends overall survival to at least 15 months in patients with pleural malignant mesothelioma, according to late-breaking results from the MAPS2 trial presented today at the ESMO 2017 Congress in Madrid.

“Malignant pleural mesothelioma (MPM) is a rare disease usually caused by occupational exposure to asbestos. First line therapy is pemetrexed and platinum chemotherapy, with or without bevacizumab. There is no approved second line treatment and drugs that have been tested in this setting had low efficacy, with a disease control rate under 30%. Phase II studies have shown promising activity of checkpoint inhibitors as second line treatment.”

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