BI’s Gilotrif moves toward approval

FDA and EMA accept regulatory applications for Boehringer Ingelheim’s Gilotrif (afatinib) for treatment of advanced squamous cell carcinoma of the lung

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RIDGEFIELD, Conn.—Boehringer Ingelheim today announced that both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line chemotherapy. Afatinib has also been granted Orphan Drug Designation by the FDA—a status given to a product intended for the treatment of a rare disease or condition.
Dr. Jörg Barth, corporate senior vice president, Therapy Area Head Oncology, Boehringer Ingelheim noted that “Working with the U.S. and EU regulatory authorities marks the next stage in our journey to hopefully provide patients with a new, oral treatment for squamous cell carcinoma of the lung, a condition with an extremely poor prognosis. This is an encouraging prospect for Boehringer Ingelheim, as we remain fully dedicated to improving and extending the lives of patients with different types of lung cancer.”
The submissions are based on data from the Phase 3 LUX-Lung 8 trial that compared Gilotrif (afatinib) to Tarceva (erlotinib) in patients with advanced SCC of the lung progressing after treatment with first-line platinum-based chemotherapy. Data from the trial showed that treatment with afatinib resulted in superior progression-free survival (PFS, primary endpoint), reducing the risk of cancer progression by 19 percent, and superior overall survival (OS, key secondary endpoint), reducing the risk of death by 19 percent compared to erlotinib in this patient population.
In the LUX-Lung 8 trial, an improvement in quality of life and control of cancer symptoms was observed with afatinib versus erlotinib. More patients had improved overall health-related quality-of-life with afatinib than with erlotinib (36 percent vs. 28 percent). Significantly more patients had an improvement in cough with afatinib than with erlotinib (43 percent vs. 35 percent). Differences in the proportion of patients with improved dyspnea (51 percent vs. 44 percent) and pain (40 percent vs. 39 percent) were not significant for afatinib versus erlotinib. Afatinib significantly delayed time to deterioration of dyspnea compared with erlotinib. Time to deterioration of both pain and cough was similar for afatinib versus erlotinib.
The rate of severe adverse events was similar between the two treatment arms with differences observed in the incidence of certain side effects. A higher incidence of severe diarrhea and stomatitis (mouth sores) was observed with afatinib compared to erlotinib (grade 3 diarrhea: 10 percent vs. 2 percent; grade 3 stomatitis: 4 percent vs. 0 percent), while a higher incidence of severe rash/acne was reported with erlotinib compared to afatinib (grade 3 rash/acne: 10 percent vs. 6 percent).
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer comprising over 85 percent of lung cancer cases. Squamous cell lung cancer develops in the cells lining the airways and represents approximately 30 percent of NSCLC cases. SCC of the lung is associated with a poor prognosis and limited survival. The median OS after diagnosis of advanced SCC is around one year.
Afatinib, an oral, once daily EGFR-directed therapy, is currently approved in more than 60 countries for the first-line treatment of specific types of EGFR mutation-positive NSCLC (under brand names: Gilotrif/Giotrif). Approval of afatinib in this indication was based on the primary endpoint of PFS from the LUX-Lung 3 clinical trial where afatinib significantly delayed tumor growth when compared to standard chemotherapy. In addition, afatinib is the first treatment to show an OS benefit for patients with specific types of EGFR mutation-positive NSCLC compared to chemotherapy. A significant OS benefit was demonstrated independently in the LUX-Lung 3 and 6 trials for patients with the most common EGFR mutation (exon 19 deletions; del19) compared to chemotherapy.
Gilotrif is an oral, once-daily kinase inhibitor that is designed to irreversibly bind and inhibit the following receptors: EGFR (ErbB1), HER2 (ErbB2) and ErbB4. Gilotrif is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research program to discover and develop innovative cancer treatments. Working in close collaboration with the international scientific community and a number of the world’s leading cancer centers, Boehringer Ingelheim’s commitment to oncology is underpinned by using advances in science to develop a range of targeted therapies for various solid tumors and hematological cancers. The current focus of late-stage research includes compounds in three areas: signal transduction inhibition, angiogenesis inhibition and cell-cycle kinase inhibition. The company is also evaluating a robust and growing pipeline of early-stage oncology compounds in areas including growth/survival signaling, immunotherapy and epigenetics.

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