LGBT Cancer Project

Squamous Cell Carcinoma

October 5, 2015

Boehringer Ingelheim has released results of a phase III trial of fatinib compared to erlotinib for the treatment of patients with previously treated advanced squamous cell carcinomas (SCC) of the lung. More patients had improved overall health-related quality-of-life (36% v. 28%, p=0·041), cough (43% v. 35%, p=0·029) and dyspnoea (51% v. 44%, p=0·061) with afatinib than with erlotinib. The rate of severe adverse events in the LUX-Lung 8 trial was similar between the two treatment arms with differences observed in the incidence of certain side effects. A higher incidence of severe diarrhoea and stomatitis (mouth sores) was observed with afatinib compared to erlotinib (grade 3 diarrhoea: 10% v. 2%; grade 3 stomatitis: 4% v. 0%), while a higher incidence of severe rash/acne was reported with erlotinib compared to afatinib (grade 3 rash/acne: 10% v. 6%). Diarrhoea occurring in patients treated with afatinib was manageable. Afatinib is under review by both the FDA and EMA for the treatment of SCC of the lung. Afatinib also has been granted Orphan Drug designation by the FDA. Afatinib currently is approved in more than 60 countries for the first-line treatment of specific types of EGFR mutation-positive non-small cell lung cancer.

June 29, 2015

Boehringer Ingelheim issued results of a phase III study of afatinib v. erlotinib in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. Treatment with afatinib significantly reduced the risk of death by 19%, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib. Significantly more patients treated with afatinib were still alive at one year compared to those treated with erlotinib (36.4 v. 28.2%). The updated analysis of PFS confirmed a significant reduction in the risk of cancer progression by 19% in patients treated with afatinib compared with erlotinib. The delay in cancer progression seen with afatinib treatment was accompanied by improved control of cancer-related symptoms: a higher proportion of patients treated with afatinib reported improvement in cough (43.4 v. 35.2%), shortness of breath (51.3 v. 44.1%) and overall well-being/quality-of-life (35.7 v. 28.3%) compared with erlotinib. The rate of severe adverse events was similar between afatinib and erlotinib treatment arms (57.1 v. 57.5%). Afatinib is approved in more than 50 countries for the first-line treatment of distinct types of EGFR mutation-positive NSCLC. Afatinib is not approved for use in patients with SCC of the lung. The complete results from this study will be the basis for global regulatory submissions later this year.

October 20, 2014

Boehringer Ingelheim issued results of a phase III trial of afatinib v. erlotinib in patients with advanced squamous cell carcinoma (SCC) of the lung. In the randomized, open-label trial, 795 patients with stage IIIB/IV SCC of the lung were randomized 1:1 to receive afatinib or erlotinib until disease progression. The planned primary analysis was based on 414 progression-free survival (PFS) events by independent review in the first 669 patients randomized (afatinib: 335, erlotinib: 334) while recruitment was ongoing. Afatinib significantly reduced the risk of disease progression by 18% when compared to erlotinib and delayed tumor growth (PFS by independent review: 2.4 v. 1.9 months; HR=0.82; p=0.043). Treatment with afatinib showed improvement in the secondary endpoint of disease control rate (DCR) compared to erlotinib (DCR: 45.7% v. 36.8%; p=0.020). Objective response rate was 4.8% in the afatinib arm v. 3% in the erlotinib arm (p=0.233). More patients reported an improvement in their global health status/quality of life (p=0.026) and cough (p=0.01) with afatinib v. erlotinib; no difference was observed with pain (p=1.0) and dyspnea (p=0.298) between groups. There was no significant difference in the time to deterioration across these four measures. The overall rate of severe (>/= grade 3) adverse events was comparable between both therapies. Incidence of severe adverse events was 50.2% in patients treated with afatinib compared to 49.1% with erlotinib. A higher incidence of severe diarrhea and stomatitis was observed in patients treated with afatinib compared to erlotinib (severe diarrhea: 9% v. 2%; stomatitis: 3% v. 0%), while there was a higher incidence of severe rash/acne observed with erlotinib compared to afatinib (9% v. 6%).

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