Boehringer Ingelheim 3rd-generation EGFR TKI, BI 1482694, receives FDA Breakthrough Therapy Designat

• New data from Phase I/II clinical trial presented at ESMO Asia 2015 Congress showcase the potential for BI 1482694* to become a new treatment option for EGFR mutation-positive lung cancer
• In 62% of patients with T790M-positive NSCLC objective responses were achieved, including 32 patients (46%) with confirmed tumour response
• Based on these data, BI 1482694 has been granted Breakthrough Therapy Designation by the US FDA; first regulatory submission has been filed in Korea

INGELHEIM, Germany -- (BUSINESS WIRE) --

Boehringer Ingelheim today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for its novel, 3^rd-generation, epidermal growth factor receptor (EGFR) mutation-specific tyrosine kinase inhibitor (TKI), BI 1482694* (HM61713**). The BTD is based on results from the Phase I/II HM-EMSI-101 clinical trial which were presented at the ESMO Asia 2015 Congress in Singapore. BTDs have been established by the FDA to facilitate and expedite the development and review of promising drugs for serious or life-threatening conditions.

The HM-EMSI-101 clinical trial investigated BI 1482694 in patients with advanced and pre-treated EGFR mutation-positive non-small cell lung cancer (NSCLC). Based on these positive data, a New Drug Application for HM61713 / BI 1482694 has recently been submitted to the Korean Ministry of Food and Drug Safety by Hanmi Pharmaceutical Co. Ltd, with whom Boehringer Ingelheim has an exclusive license and collaboration agreement for the development and global commercialisation rights (except South Korea, China and Hong Kong) of BI 1482694.

Results from the Phase I/II clinical trial of BI 1482694 presented at the EMSO Asia 2015 Congress in Singapore, showcase the tumour activity and favourable safety profile of BI 1482694 at the recommended Phase II dose of 800mg once daily, previously presented at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting. In patients with T790M-positive NSCLC who had previously been treated with an EGFR TKI:

• Objective responses (ORs) by independent assessment were observed in 62% patients, including 32 patients (46%) whose tumour response had been confirmed by the time of data cut-off
• Disease control rate was 91% by independent assessment.

At the time of data cut off, median duration of response had not yet been reached and will be reported at a later date.

The most common treatment-related adverse events (AEs) included (total/grade 3) diarrhoea (55%/0%), nausea (37%/0%), rash (38%/5%) and pruritus (skin itching: 36%/1%) – the majority of AEs were mild-to-moderate.

Coordinating investigator Professor Keunchil Park, Division of Hematology & Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, South Korea commented, “These data further validate BI 1482694 as a potential treatment for lung cancer patients who encounter resistance to 1^st- or 2^nd-generation EGFR targeting treatments. Being able to improve outcomes of EGFR mutation-positive patients with minimum burden on their overall wellbeing is the goal for both patients and oncologists, so we eagerly await the duration of response and progression-free survival data from this study, as well as results of the broader clinical programme which is underway.”

The pivotal clinical development programme of BI 1482694 in lung cancer, ELUXA, encompasses multiple trials including Phase III studies starting in 2016. The first pivotal Phase II trial (ELUXA 1/HM-EMSI-202) is designed to further investigate the efficacy and safety of BI 1482694 in patients with NSCLC with acquired T790M-mediated resistance after first-line EGFR TKIs.

Dr Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented, “The clinical trial results we have seen so far for BI 1482694 are very encouraging and have led to the FDA Breakthrough Designation and a first regulatory submission in Korea. The T790M mutation is the most common resistance mechanism found in about half of the patients previously treated with currently available EGFR TKIs. Our aim at Boehringer Ingelheim is to prolong the continuum of treatment with targeted therapies for patients with EGFR mutation-positive lung cancer with a treatment that could potentially be efficacious even after the inevitable occurrence of resistance to the initial treatment.”

Regulatory update

Boehringer Ingelheim aims to achieve first market authorisation for BI 1482694 in patients with T790M-positive NSCLC in 2017.

• In December 2015, the US FDA granted BI 1482694 with Breakthrough Therapy Designation
• In October 2015, a New Drug Application for HM61713 / BI 1482694, was filed to the Korean Ministry of Food and Drug Safety.

About the HM-EMSI-101 study

This is a Phase I/II, multicenter study of BI 1482694 in Korean patients. All patients included in the trial had been previously treated with at least one EGFR TKI and may have received additional lines of chemotherapy or other systemic treatments. At the recommended Phase II dose (RP2D: 800mg qd), all eligible patients had to have confirmed T790M mutation in the tumour. The primary endpoint was OR; secondary endpoints included duration of response, disease control rate, progression-free survival (PFS) and safety.

About the ELUXA 1 (HM-EMSI-202) study

ELUXA 1 is an ongoing pivotal Phase II global clinical trial. It is designed to further investigate the efficacy and safety of BI 1482694 in patients with NSCLC whose tumours acquired T790M-mediated resistance after first-line EGFR TKIs. The ELUXA 1 trial is part of a broad ELUXA pivotal trial programme, which will include the initiation of Phase III studies in 2016.

*BI 1482694 is an investigational, novel, oral, 3^rd-generation, EGFR mutant-specific tyrosine kinase inhibitor developed to target tumours with EGFR mutations including the resistance mutation T790M.

**Boehringer Ingelheim has an exclusive license and collaboration agreement with Hanmi Pharmaceutical Co. Ltd for the development and global commercialisation rights (except South Korea, China and Hong Kong) of BI 1482694 (HM61713).

Intended audiences

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

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