Boehringer submits NSCLC pill
pharmafile | October 14, 2013 | News story | Sales and Marketing |
Boehringer Ingelheim has submitted its oral triple angiokinase inhibitor nintedanib for scrutiny by the European Medicines Agency.
Nintedanib was impressive in presentations at the European Cancer Congress earlier this month, demonstrating its ability to extend life when added to chemotherapy in adenocarcinoma patients following chemo.
Adenocarcinoma is the most common form of non-small cell lung cancer (NSCLC) – and as most patients with an advanced stage of the disease will get worse after initial therapy, second line treatments which are effective will form a key part of treatment.
The German manufacturer wants approval for the drug, in combination with docetaxel, for second line treatment of NSCLC of adenocarcinoma histology after first line chemotherapy.
The Phase III LUME-Lung 1 trial showed that nintedanib plus docetaxel lengthened overall survival (OS) by 2.3 months for advanced NSCLC patients versus placebo and docetaxel.
Median OS rose from 10.3 months in the placebo arm to 12.6 months in the nintedanib arm – and the earlier that adenocarcinoma patients failed first line chemotherapy, the more benefit they got from nintedanib.
Patients who progressed within nine months after the start of their first-line treatment had a larger median OS of three months – 10.9 months versus 7.9 months.
Adenocarcinoma accounts for almost half of all NSCLC but this is a hard-to-treat group, and the LUME-Lung 1 results are the first promising findings in almost a decade in terms of OS for patients where initial chemotherapy has failed.
Boehringer has also just received approval in Europe for Giotrif (afatinib), the first irreversible ErbB family blocker, for the treatment of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor naive adult patients, with locally advanced or metastatic NSCLC and activating EGFR mutations.
Klaus Dugi, Boehringer’s corporate senior vice president medicine, said: “We are proud that nintedanib, a compound out of our innovative oncology research programme, is the second compound in our portfolio to be filed with the European Medicines Agency.”
Lung cancer is common and the prognosis for sufferers is poor, with only one in six patients surviving five years from diagnosis. More than two-thirds of adenocarcinoma patients are diagnosed at a late-stage when curative treatment is no longer feasible, Boehringer says.
Adam Hill
