FDA Grants Priority Review to Keytruda Plus Chemotherapy for Lung Cancer Subtype

Excerpt:

“The FDA granted priority review designation to a supplemental biologics license application that seeks approval of pembrolizumab for use in combination with chemotherapy as first-line treatment of metastatic squamous non-small cell lung cancer regardless of PD-L1 expression.

“The agency set a target action date of Oct. 30.”

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Tecentriq Combo Success Boosts Roche in Lung Cancer

Excerpt:

“A combination of Roche AG’s immunotherapy Tecentriq with two older cancer drugs bested chemotherapy in extending progression-free survival (PFS) among previously untreated patients with squamous non-small cell lung cancer (NSCLC), the Swiss pharma announced March 20.

“Results from the Phase 3 study, known as IMpower 131, could position Tecentriq as the first checkpoint inhibitor to market for first-line treatment of squamous NSCLC, a subset that accounts for 25% to 30%of all NSCLC cases.

“Roche only disclosed topline results for the combination regimen’s effect on PFS. At this point, no benefit in overall survival (OS) between the treatment and control groups was reported, but the study will continue to allow for further observation.”

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FGFR Inhibitor Dovitinib Shows Modest Efficacy in Squamous NSCLC

Excerpt:

“The FGFR inhibitor dovitinib showed modest efficacy in a phase II trial of patients with pretreated, advanced squamous cell carcinoma (SCC) of the lung with FGFR1 amplification. Further work on the drug, in particular to find biomarkers of efficacy, was deemed warranted.

“ ‘The majority of new cytotoxic chemotherapies for the treatment of non–small-cell lung cancer (NSCLC) such as pemetrexed or targeted agents such as gefitinib or erlotinib are not indicated for the SCC subtype because of a lack of efficacy or because activity is limited to tumors with specific genetic alterations that are rarely found in patients with squamous cell NSCLC,’ wrote study authors led by Myung-Ju Ahn, MD, PhD, of Samsung Medical Center in Seoul, South Korea. SCC accounts for about 30% of all NSCLC cases.”

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Sacituzumab Govitecan Shows Promise for Metastatic NSCLC

Excerpt:

“Treatment with sacituzumab govitecan induced objective responses and appeared tolerable in patients with metastatic non–small cell lung cancer who had received first-line platinum-based therapy, according to the results from an expansion cohort of a phase 1/2 study presented at the ASCO Annual Meeting.

” ‘This therapy showed efficacy for squamous and non-squamous patients as well as for patients with prior PD-1/PD-L1 therapy,’ D. Ross Camidge, MD, PhD, professor in the division of medical oncology and Joyce Zeff chair in lung cancer research at University of Colorado Anschutz Medical Campus, said during a presentation.

Sacituzumab govitecan (IMMU-132, Immunomedics) is an antibody drug conjugate comprised of SN-38 — the active metabolite of irinotecan, a topoisomerase inhibitor — conjugated to an anti–Trop-2 humanized monoclonal antibody.”

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US Widens Use of Boehringer's Lung Cancer Drug Gilotrif

Excerpt:

“US health officials have expanded the approved indications for Boehringer Ingelheim’s Gilotrif, clearing its use in patients with squamous cell carcinoma of the lung.

“Gilotrif (afatinib), an oral, once-daily EGFR-directed therapy, is currently cleared in the US for the first-line treatment of specific types of EGFR mutation-positive non-small cell lung cancer.

“Approval for squamous cell carcinoma of the lung, a disease linked with a particularly bleak poor prognosis of one-year survival post diagnosis, was based on data from the head-to-head LUX-Lung 8 trial in patients whose tumours progressed after first-line chemotherapy.”

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ELCC 2016 News: Updates from CheckMate 063 and 017 Trials Confirm Nivolumab Efficacy in Patients with Advanced Platinum-Refractory Squamous NSCLC

Excerpt:

“The baseline serum cytokine levels of platinum pretreated patients with advanced squamous non-small cell lung cancer (NSCLC) altered the efficacy of immunotherapy with nivolumab, a fully human IgG4 antibody inhibiting the programmed death-1 (PD-1) immune checkpoint.

“Updated findings from the phase II CheckMate 063 trial of nivolumab and phase III CheckMate 017 trial of nivolumab versus docetaxel in patients with advanced platinum-refractory squamous NSCLC were submitted by Dr Hervé Lena, Service de Pneumologie, Centre Hospitalier Universitaire de Rennes, Rennes, France and colleagues, including Suresh Ramalingam who presented the results at the European Lung Cancer Conference (ELCC), held in Geneva, Switzerland, 13 to 16 April, 2016.”

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CHMP Recommends Afatinib for Second-Line NSCLC

“Afatinib (Giotrif, EU; Gilotrif, US) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) as a treatment for patients with advanced squamous cell non–small cell lung cancer (NSCLC) following progression on platinum-based chemotherapy, according to Boehringer Ingelheim, the manufacturer of the irreversible EGFR inhibitor.

“The CHMP opinion, which recommends that the treatment should gain approval from the European Medicines Agency in this setting, is based on data from the phase III LUX-Lung 8 trial. In the study, second-line afatinib reduced the risk of both disease progression and death by 19%, compared with erlotinib (Tarceva) in patients with advanced squamous cell carcinoma of the lung.”


Lung Cancer Patients Gain Access to New Treatment for Fourth Time in Two Months

“The International Association for the Study of Lung Cancer (IASLC) is pleased to hear of another approval by the U.S. Food and Drug Administration (FDA) that helps in the fight against lung cancer—the fourth in two months. The FDA approved necitumumab (Portrazza) in combination with standard chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for their advanced disease.

“Necitumumab binds to the epidermal growth factor receptor (EGFR), a protein commonly found on squamous NSCLC tumors, and blocks EGFR from binding its ligands, thus preventing tumor growth. Necitumumab is the first monoclonal antibody type of EGFR inhibitor to be approved in lung cancer, whereas there are a number of tyrosine kinase type of EGFR inhibitors (TKI) already FDA approved and used in clinical practice. These TKIs include gefitinib, erlotinib, afatinib, and osimertinib.”


FDA Approves Portrazza to Treat Advanced Squamous Non-Small Cell Lung Cancer

“The U.S. Food and Drug Administration today approved Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer.

“Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015. The most common type of lung cancer, non-small cell lung cancer, is further divided into two main types named for the kinds of cells found in the cancer – squamous cell and non-squamous cell (which includes adenocarcinoma).”