BOEHRINGER-INGELHEIM

Boehringer Ingelheim today announced the initiation of a Phase II trial of afatinib* (Giotrif^® ) in combination with pembrolizumab (Keytruda^® ) for patients with locally advanced or metastatic squamous cell carcinoma (SqCC) of the lung.

Benjamin Levy, MD, Clinical Director, Sidney Kimmel Cancer Center, Johns Hopkins Medicine at Sibley Memorial Hospital Washington DC, USA said, “Given the complexity of tumours and their ability to evade immune destruction, combination approaches rooted in both clinical and scientific rationale are desperately needed. Bringing together two drugs, afatinib and pembrolizumab, which have each demonstrated meaningful activity and survival advantages in advanced stage squamous cell lung cancer patients, is an attractive strategy that needs to be further investigated as a treatment combination. The potential synergy in these agents will hopefully advance care and therapeutic options for this group of patients.”

Afatinib is approved in the EU (Giotrif^® ), US (Gilotrif^® ) and other markets in patients with advanced SqCC of the lung whose disease has progressed on or after (EU label) / after (US label) treatment with platinum-based chemotherapy.

Pembrolizumab is approved in the US, EU, Japan and other markets for the treatment of previously-untreated patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression (tumour proportion score (TPS) >50%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations. Pembrolizumab is also indicated for the treatment of previously-treated patients with metastatic NSCLC whose tumours express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy.

The trial is being conducted in collaboration with a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada) and the combination of afatinib and pembrolizumab studied in this trial is currently not an approved treatment regimen in the studied indication.

Dr. Victoria Zazulina, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim said, “We are excited to collaborate with MSD and launch this trial, allowing us to gain further insights into the opportunities around treatment of squamous cell carcinoma of the lung. Around the world, patients with this type of cancer are already benefitting from anti-PD-1 therapies and afatinib, the only oral tyrosine kinase inhibitor (TKI) used in this indication. It is intriguing to combine both approaches in an attempt to improve the outcomes for patients with squamous lung cancer and equip physicians with new options.”

The Phase II trial will include approximately 60 patients who have progressed or relapsed on or after prior platinum-based chemotherapy, and who have not previously received therapy with an anti-PD-1 therapy, a PD-L1/L2 antibody, or other checkpoint inhibitor or anti-EGFR targeted therapy. The trial aims to measure the decrease in tumour size (primary endpoint; objective response rate) and will confirm the dose of afatinib in combination with the standard dose of pembrolizumab, as well as the tolerability of this new regimen. In addition, it will evaluate anti-tumour activity in terms of disease control, duration of response, progression-free survival (PFS) and overall survival (OS).

SqCC of the lung is the second largest sub-type of NSCLC and represents approximately 20-30% of NSCLC cases. Patients with advanced SqCC of the lung typically have a poor prognosis and the median overall survival after diagnosis is around one year.

Afatinib is also approved in over 70 countries for the first-line treatment of EGFR mutation-positive NSCLC and continues to be more broadly studied beyond the approved indications.

*Afatinib is approved in more than 70 countries, including the EU, Japan, Taiwan and Canada under the brand name Giotrif ^® , in the US under the brand name Gilotrif ^® and in India under the brand name Xovoltib ^® for use in patients with distinct types of EGFR mutation-positive NSCLC. Afatinib is also approved in the EU, US and other markets for the treatment of patients with advanced SqCC of the lung whose disease has progressed (on or) after treatment with platinum-based chemotherapy. Afatinib is under regulatory review by health authorities in other countries worldwide. Registration conditions differ internationally, please refer to locally approved prescribing information.

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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Boehringer Ingelheim
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Susanne Granold
Phone: +49 6132 – 77 93319
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Email: press@boehringer-ingelheim.com