Lung (includes NSCLC, SCLC, Mesothelioma)

SEC Fines Clovis Oncology Inc., Executives $20.8 Million For Lying About Cancer Drug Effectiveness

(MarketWatch) Sept 18, 2018 - Clovis Oncology Inc., will pay $20 million to settle charges by the Securities and Exchange Commission that it misled investors about the effectiveness of the company's developmental lung cancer drug, rociletinib, or Roci, according to an SEC press release. Its CEO Patrick Mahaffy, and Erle Mast, the company's former CFO, also settled charges.

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Thermal Ablation Effectively Treats Early-Stage Lung Cancer

(RSNA) Sept 18, 2018 - Thermal ablation is a safe, effective treatment for early-stage lung cancer, according to a study published in the journal Radiology. The results show that ablation may be an effective alternative for patients who cannot undergo lung cancer surgery because of age or health status.

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The Risks to Children From Adults Who Smoke

(New York Times/Personal Health) Sept 17, 2018 - The hazards of secondhand smoke are firmly established. According to the American Academy of Pediatrics, breathing in someone else’s smoke is responsible for about 3,000 deaths from lung cancer and tens of thousands of deaths from heart disease among nonsmokers annually.

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CBT Pharmaceuticals Initiates the APOLLO Oncology Clinical Trials Program

(Morningstar) Sept 18, 2018 - CBT Pharmaceuticals, a U.S. and China-based innovative biopharmaceutical company committed to becoming a leader in the discovery and development of oncology combination therapies, today announced the initiation of the APOLLO Oncology Clinical Trials Program.

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Novel Mesothelioma Treatment Closer to FDA Approval

(Asbestos.com) Sept 17, 2018 - Standard-of-care treatment for patients with pleural mesothelioma may soon include Tumor Treating Fields (TTF), a novel therapy involving electric currents that disrupt cancer cell division and inhibit tumor growth.

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Artificial Intelligence Tool Accurately Identifies Cancer Type & Genetic Changes in Each Patient’s Lung Tumor

(NYU Langone) Sept 17, 2018 - A study found that a type of artificial intelligence (AI), or “machine learning” program, could distinguish with 97 percent accuracy between adenocarcinoma and squamous cell carcinoma—two lung cancer types that experienced pathologists at times struggle to parse without confirmatory tests.

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Natera Signs Agreement with Bristol-Myers Squibb to Investigate Signatera™ ctDNA Assay as a Potential Biomarker for Opdivo (nivolumab) in a Prospective Phase 2 Adjuvant Non-Small Cell Lung Cancer Clinical Trial

(Natera) Sept 13, 2018 - First study using ctDNA-based minimal residual disease assessment for immunotherapy in the adjuvant NSCLC setting.

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Helix BioPharma Corp. Initiates Enrollment of the Second Last Cohort in U.S. Combination Treatment Study of Its Lung Cancer Drug Candidate L-DOS47

(MarketWatch) Sept 13, 2018 - Helix BioPharma Corp., an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, today announced that the Safety Review Committee ("SRC") reviewed safety data from the fifth dosing cohort of the Company's LDOS001 study and recommended that Helix begin enrollment of patients into the sixth dosing cohort.

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FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Monotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Patients Whose Tumors Express PD-L1 (TPS ≥1%)

(Merck) Sept 12, 2018 - Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review and granted priority review to a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) without EGFR or ALK genomic tumor aberrations. The application is based on data from the pivotal Phase 3 KEYNOTE-042 trial, one of five Phase 3 clinical trials with KEYTRUDA in NSCLC to demonstrate a significant improvement in overall survival. Data from the trial were presented earlier this year at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Jan. 11, 2019.

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Spectrum Pharmaceuticals Expands Poziotinib Clinical Trial Into First-Line Therapy and Doses First Patient

(Markets Insider) Sept 12, 2018 - Spectrum Pharmaceuticals, Inc., a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that it has initiated two new cohorts for first-line, locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR or HER2 exon 20 insertion mutations in its current Phase 2 non-small cell lung cancer (NSCLC) clinical trial.

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FDA Grants Priority Review to Keytruda to Treat Non-Small Cell Lung Cancer Subgroup

(Curetoday.com) Sept 12, 2018 - The Food and Drug Administration (FDA) granted priority review to Keytruda (pembrolizumab) monotherapy for the first-line treatment of patients with locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) whose tumors express PD-L1 without EGFR or ALK genomic tumor aberrations.

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Commentary: Jack West: Why CMS' Step Therapy Decision Is so Dangerous

(Medscape Medical News) Sept 6, 2018 - Practicing medicine today requires balancing cost, treatment timing, and access to the best therapies for patients. This is especially critical in cancer, where the costs of newer agents have entered the stratospheric range, and where more narrowly defined treatments based on molecular selection are optimal.

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Merck's Keytruda Clocks Up New Win As EU Approves Chemo Cocktail

(Reuters) Sept 10, 2018 - Merck & Co’s key cancer drug Keytruda has been approved for use in Europe in combination with chemotherapy in previously untreated lung cancer patients, marking a further advance for the product after uncertainty about its EU prospects a year ago.

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Roche Provides Update on Supplemental Biologics License Application (sBLA) for TECENTRIQ in First-line Metastatic Non-Squamous NSCLC

(Roche) Sept 6, 2018 - On September 05 2018, Roche was notified by the U.S. Food and Drug Administration (FDA) that the review period for the supplemental Biologics License Application (sBLA) for TECENTRIQ® (atezolizumab) in combination with Avastin® (bevacizumab), carboplatin and paclitaxel for the initial treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) has been extended by three months. The extension allows the FDA time to review additional information requested in support of the sBLA. FDA determined that the submission of this information constituted a major amendment to the sBLA resulting in this extension of the PDUFA goal date.

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Roche To Present New Data From Its Extensive Lung Cancer Programme At The 2018 World Conference on Lung Cancer (WCLC)

(Roche) Sept 6, 2018 - Roche today announced that new data from its broad clinical development programme across different types of lung cancer will be presented at the International Association for the Study of Lung Cancer (IASLC) 2018 World Conference on Lung Cancer (WCLC), taking place from 23–26 September in Toronto, Canada. 10 abstracts have been accepted, including three ‘late breakers’ and five oral presentations. “We look forward to presenting new data from our comprehensive lung cancer programme, including new immunotherapy and targeted treatment strategies across different types of lung cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are particularly pleased to be sharing positive TECENTRIQ data in extensive-stage small cell lung cancer, which has seen limited progress in treatment over the last two decades, as well as new pivotal data for our investigational therapy entrectinib for the treatment of ROS1 fusion-positive lung cancer.”

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FDA Extends Review Period for Roche Cancer Treatment License

(Morningstar/Dow Jones Newswires) Sept 6, 2018 - Roche Holding AG said Thursday that the FDA has extended the review period for a license application for its Tecentriq lung-cancer treatment by three months. The extension allows the FDA time to review additional information requested in support of the application, Roche said. The combination of Tecentriq with Avastin, carboplatin and paclitaxel for the treatment of a type of lung cancer received priority review status from the FDA in May, following promising results from a phase 3 trial.

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Data from Merck’s Leading Lung Cancer Research Program with KEYTRUDA® (pembrolizumab) to be Presented at IASLC 19th World Conference on Lung Cancer

(Merck) Sept 6, 2018 - Merck, known as MSD outside the United States and Canada, today announced that investigational data from the company’s leading lung cancer research program with KEYTRUDA, Merck’s anti-PD-1 therapy, will be presented at the IASLC 19th World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Toronto from Sept. 23-26.

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Tumor Treating Fields Plus Standard of Care Chemotherapy Significantly Extends Median Overall Survival by 6.1 Months in STELLAR Phase 2 Registration Trial in Mesothelioma Compared to Historical Control

(Morningstar) Sept 5, 2018 - Novocure announced final results from its STELLAR phase 2 registration trial in mesothelioma, demonstrating a significant extension in median overall survival among patients treated with Tumor Treating Fields plus standard of care chemotherapy compared to historical control data of patients who received standard of care chemotherapy alone.

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Checkpoint Therapeutics Announces Encouraging Safety and Efficacy Data from Phase 1/2 Clinical Trial of EGFR Inhibitor CK-101

(Morningstar) Sept 6, 2018 - Checkpoint Therapeutics, Inc. today announced positive preliminary safety and efficacy data from an ongoing Phase 1/2 clinical trial of CK-101 (also known as RX518), a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) being evaluated in advanced non-small cell lung cancer (NSCLC).

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Merrimack Completes Enrollment in Randomized Phase 2 SHERLOC Study of MM-121 (seribantumab) in Non-Small Cell Lung Cancer (NSCLC)

(Morningstar) Sept 6, 2018 - Merrimack Pharmaceuticals, Inc., a clinical-stage oncology company focused on biomarker-defined cancers, today announced that it has completed enrollment in its ongoing SHERLOC study, a Phase 2 clinical trial evaluating its lead investigational drug candidate, MM-121, in patients with heregulin positive NSCLC.

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