Tiny Ignyta’s Lung Cancer Drug Bested Pfizer’s. Probably. Will We Ever Know For Sure?

Excerpt:

“There should have been a drug to prolong Stuart Brown’s life. But when his first option failed him, it seemed there was nothing else to try.

“Then came a drug made by Ignyta Pharmaceuticals, a San Diego-based drugmaker, that shrank his tumors and has kept them in check for more than a year. Results of a 32-patient study of the drug, presented today at the World Conference on Lung Cancer in Yokohama, Japan, show a best case scenario: the medicine shrank tumors in 79% of patients and kept working for a median 28.6 months, about 10 months longer than the current drug, Pfizer’s Xalkori, did in separate clinical trials. Lung cancer doctors are impressed, and the results best what financial analysts say could be a best-case scenario for Ignyta’s stock, which has already increased 200% year-to-date.”

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MET/EGFR Combo Effective for Advanced NSCLC

Excerpt:

“The combination of osimertinib (Tagrisso) and the MET inhibitor savolitinib showed signs of efficacy for pretreated patients with MET-positive, EGFR-mutant non–small cell lung cancer (NSCLC), regardless of prior treatment with a T790M-directed therapy, according to findings from part B of the TATTON trial presented at the 2017 World Conference on Lung Cancer (WCLC).

“Across patients in the phase Ib study (N = 64), the objective response rate (ORR) was 47% with the combination of osimertinib and savolitinib. In those pretreated with a T790M-directed therapy (n = 30), the ORR was 33% and in those with T790M-negative disease (n = 23) the ORR was 61%. In patients with T790M-positive disease (n = 11), the ORR was 55% for the combination.”

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US FDA Accepts Supplemental Biologics License Application for Imfinzi in Locally Advanced Unresectable Non-Small Cell Lung Cancer

Excerpt:

“AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) for the treatment of patients with locally advanced (Stage III) unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. The FDA has granted Imfinzi Priority Review status.”

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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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