Afatinib to be evaluated in combination with pembrolizumab in new trial for patients with SqCC of th

Boehringer Ingelheim to conduct trial in collaboration with a subsidiary of Merck (MSD).

Boehringer Ingelheim has initiatedf a Phase II trial of afatinib (Gilotrif) in combination with pembrolizumab (Keytruda) for patients with locally advanced or metastatic squamous cell carcinoma (SqCC) of the lung.

Benjamin Levy, Clinical Director, Sidney Kimmel Cancer Center, Johns Hopkins Medicine at Sibley Memorial Hospital Washington DC, 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 US (Gilotrif), EU (Giotrif) 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 (MSD) and the combination of afatinib and pembrolizumab studied in this trial is currently not an approved treatment regimen in the studied indication.

"This collaboration will provide invaluable information about the use of afatinib and pembrolizumab in combination to treat squamous cell carcinoma of the lung," said Martina Flammer, Vice President, Clinical Development & Medical Affairs Specialty Care, Boehringer Ingelheim Pharmaceuticals, Inc. "Furthermore, the trial underscores our commitment to continually investigate novel approaches for cancer treatment."

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 or 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, and overall survival.