Boehringer Ingelheim a Step Closer to Bringing Firm’s First Anti-Cancer Drug to Market
Boehringer Ingelheim announced on September 20, 2012, the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of afatinib. This regulatory milestone brings afatinib a step closer to becoming available to patients with advanced and metastatic Non-Small Cell Lung Cancer (NSCLC) harboring EGFR mutations. Afatinib, if approved, will be a direct competitor to currently available EGFR tyrosine kinase inhibitors Tarceva and Iressa. What differentiates afatinib is that it is an irreversible ErbB family inhibitor of EGFR (ErbB1), HER2 (ErbB2) and ErbB4, whereas Tarceva and Iressa are reversible inhibitors that target EGFR only.
GlobalData estimates the global NSCLC therapeutics market is currently worth approximately $5 billion and is forecast to reach $9.5 billion by 2018. Notably, AstraZeneca's $500m drug Iressa (gefitinib) and Roche's $1 billion drug Tarceva (erlotinib) are key market players. However, sales for Tarceva also include use for pancreatic cancer. Boehringer Ingelheim is also trying to test the drug's potential to treat other cancer patient populations. Afatinib has reached Phase III clinical development in breast cancer and head and neck cancer, and if the results of these trials are positive, Boehringer Ingelheim will seek further approvals.
The results of LUX-Lung 3 trial, a global, randomized, open-label, Phase III trial, provide pivotal support for this MAA submission. Afatinib demonstrated strong efficacy versus standard chemotherapy agents, Eli Lilly's Alimta (pemetrexed) and cisplatin. The study included 345 previously untreated patients with EGFR mutation positive NSCLC, and patients who received afatinib as a first-line treatment lived for almost one year without their tumor growing (progression-free survival (PFS) of 11.1 months) versus just over half a year (PFS of 6.9 months) for those receiving chemotherapy (pemetrexed/cisplatin). Furthermore, NSCLC patients with tumors harboring the two most common EGFR mutations (del19 and L858R, accounting for 90% of all tumors with EGFR mutations) taking afatinib lived for over a year without disease progression (PFS of 13.6 months) versus just over half a year (PFS of 6.9 months) for those in the comparator arm.
More of the patients who took afatinib experienced an improvement in shortness of breath, cough, and chest pain, which are common symptoms in NSCLC patients, and a delay in the deterioration of these symptoms, as well as overall improved quality of life. The safety profile was also positive for afatinib, as adverse events were manageable and the discontinuation rate was low.
Based on available clinical trial data in NSCLC patients, it is difficult to accurately compare afatinib with the currently available EGFR inhibitors, as continuous improvements in disease diagnosis and standards of care can explain any differences. Interestingly, Boehringer Ingelheim has already initiated two head-to-head trials (LUX-Lung 7 and 8) comparing afatinib to Iressa (gefitinib) and Tarceva (erlotinib), respectively, to demonstrate any potential efficacy and safety superiority of afatinib. The results of the above trials will be highly anticipated and give a clearer picture for the drug's positioning and success. If afatinib shows superiority in these clinical trials, Boehringer Ingelheim will have a very strong drug candidate for the treatment of NSCLC patients. In case afatinib shows equivalence or inferiority, there will be additional challenges in gaining market share and Boehringer Ingelheim will have to adjust pricing and marketing strategies accordingly. Undeniably, the approval of afatinib will further increase the competitiveness of this market segment.
GlobalData expects Boehringer Ingelheim to receive the EMA's opinion during the second quarter of 2013, which most likely will be a positive one after taking into consideration the efficacy and safety profile of afatinib. But most importantly, the approval of afatinib will be a major milestone for Boehringer Ingelheim, as it will become the company's first marketed anticancer drug, and an impressive success story for the firm's R&D shift into the oncology therapy area which only began in 2006. With two more anticancer drugs in the pipeline, nintedanib for NSCLS and ovarian cancer, and volasertib for acute myeloid leukemia, in late stages of clinical development, Boehringer Ingelheim shows the firm's ambitious drive to expand in the oncology therapy area and strengthen its portfolio of products.