IQWiG assesses Boehringer's Giotrif, Novartis COPD compound

Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) issued preliminary benefit assessments for lung cancer drug Giotrif afatinib from Boehringer Ingelheim GmbH (Ingelheim, Germany) and chronic obstructive pulmonary disease (COPD) product Ultibro Breezhaler from Novartis AG (NYSE:NVS; SIX:NOVN). In treatment-naïve non-small cell lung cancer (NSCLC) patients in "relatively good" health, IQWiG said Boehringer's Giotrif has "major" benefit in patients with exon 19 deletion EGFR gene mutations and "marginal" benefit in patients with exon 21 (L858R) substitution EGFR gene mutations compared to cisplatin plus pemetrexed. IQWiG said Giotrif did not show additional benefit in patients with other EGFR gene mutations, patients with poorer health or previously-treated patients. Afatinib is a dual inhibitor of EGFR and HER2.

Separately, IQWiG said Novartis' Ultibro Breezhaler has "marginal" additional benefit vs. tiotropium plus formoterol in patients with moderate COPD and patients with severe COPD with no more than two exacerbations per year. Novartis has rights to Ultibro Breezhaler from partners Vectura Group plc (LSE:VEC) and Sosei Group Corp. (Tokyo:4565) under a 2005 deal. The product is a fixed-dose combination of glycopyrronium bromide, an inhaled long-acting muscarinic receptor antagonist (LAMA), and indacaterol, a long-acting adrenergic receptor beta 2 agonist (LABA). Boehringer and Pfizer Inc. (NYSE:PFE) co-market Spiriva tiotropium. ...