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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Long-Term Survival Rates More Than Double Previous Estimates for Locally Advanced Lung Cancer

Excerpt:

“Long-term results of a phase III clinical trial indicate that survival rates for patients receiving chemoradiation for unresectable, locally advanced non-small cell lung cancer (NSCLC) may be more than twice as high as previous estimates. At five years following treatment with a standard dose of 60 Gray (Gy) radiation delivered in 30 fractions, the overall survival rate was 32 percent, setting a new benchmark of survival for patients with inoperable stage III NSCLC. The trial, RTOG 0617, also confirms that a standard dose of radiation therapy is preferable to a higher dose and that cetuximab offers no additional survival benefit for these patients. Findings will be presented today at the 59th Annual Meeting of the American Society for Radiation Oncology (ASTRO) in San Diego.”

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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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#ESMO17 ROUNDUP: Merck’s Data on Keytruda/Chemo Combo for Lung Cancer Takes Early Spotlight at ESMO

Excerpt:

“Merck’s abstract $MRK on its big study of Keytruda (pembrolizumab) combined with chemo hit early at ESMO, attracting considerable attention for the impressive progression-free survival data the pharma giant posted as a frontline therapy for non-small cell lung cancer.

“The scoop: The median PFS hit 19 months for the combo arm compared to 8.9 months for chemo alone. The 18-month overall survival rate was 70% with pembro + chemo and 56% with chemo. That was an easy winner at the FDA and the new mark to beat in the hottest competition in drug development.”

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Jack West, MD: Top Five Lung Cancer Abstracts at ESMO 2017

Excerpt:

“The European Society for Medical Oncology (ESMO) 2017 Congress is just around the corner, and we can already say with confidence that there will be many provocative presentations, including several that are poised to change practice. At this point, we can only rely on the abstracts and press releases for several of these, but here are my early impressions on the top five presentations in lung cancer for ESMO 2017.”

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Blood Tumor Markers May Warn When Lung Cancer Patients Are Progressing on Targeted Treatments

Excerpt:

“For many years, oncologists have known that cancers can secrete complex molecules into the blood and that levels of these molecules can be easily measured. These so-called ‘tumor markers’ are traditionally associated with a single dominant cancer type, for example Prostate Specific Antigen (PSA) linked to prostate cancer, Carcinoembryonic antigen (CEA) to colorectal cancer, CA125 to ovarian cancer, CA19.9 to pancreatic cancer and CA27.29 to breast cancer. However, the real challenge has been to determine a practical use for these markers. They don’t appear to be useful as a means of screening otherwise healthy people for evidence of underlying cancers.”

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Alectinib: ALEX and ALUR trials show CNS benefit in NSCLC

Excerpt:

“Data from two separate phase 3 studies to be presented at the ESMO 2017 Congress in Madrid, show alectinib’s particular central nervous system (CNS) activity in patients with advanced non-small cell lung cancer involving a mutation of the anaplastic lymphoma kinase gene (ALK-positive NSCLC).

Findings from the ALUR trial (1), as well as a secondary analysis of the ALEX trial (2) show alectinib can significantly decrease CNS progression of NSCLC, both in the first-line as well as the second-line treatment setting.

” ‘Patients with NSCLC have a high risk of CNS and brain metastases,’ commented Prof. Fiona Blackhall, from the University of Manchester and The Christie Hospital, UK.”

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Roche Presents Data From Global Phase III Study Showing Significant Clinical Benefit of Alecensa (Alectinib) in Later-Line Advanced ALK-Positive Lung Cancer

Excerpt:

“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the global phase III ALUR study showing that Alecensa® significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 85% compared to chemotherapy in patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), who had progressed following treatment with platinum-based chemotherapy and crizotinib (hazard ratio [HR]=0.15, 95% CI: 0.08-0.29, p<0.001). Median PFS reported by the investigators, the primary endpoint of the study, was 9.6 months in patients who received Alecensa (95% CI: 6.9-12.2) compared with 1.4 months (95% CI: 1.3-1.6) in those who received chemotherapy. Median PFS assessed by an independent review committee (IRC), a secondary endpoint, was 7.1 months for patients who received Alecensa versus 1.6 months for patients who received chemotherapy (HR=0.32, 95% CI 0.17–0.59; p<0.001). The safety profile of Alecensa was consistent with that observed in previous studies and compared favourably to chemotherapy.”

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