Takeda’s Exkivity (mobocertinib) has received a positive recommendation from the National Institute for Health and Care Excellence (NICE) for the treatment of epidermal growth factor receptor (EGFR) Exon 20 insertion mutation-positive (Exon20ins+) advanced non-small cell lung cancer (NSCLC), who have already received platinum-based chemotherapy.
The treatment was licensed through by Project Orbis, an international programme to review and approve promising cancer drugs helping patients access treatments faster.
NICE’s decision was supported by positive results from a phase 1/2 trial of Exkivity evaluating the safety and efficacy of oral Exkivity in patients with NSCLC.
At the November 2021 data cut off for the study, a pooled analysis of platinum pre-treated patients with EGFR Exon20 ins+ mNSCLC receiving Exkivity at a daily dose of 160mg demonstrated a confirmed objective response rate of 28%, a median duration of response of 15.8 months, a median progression free survival of 7.3 months and a median overall survival of 20 months.
The safety profile observed with Exkivity was ‘generally manageable’, the company reported, and was considered consistent with that of other tyrosine kinase inhibitors (TKIs).
NSCLC is the most common form of lung cancer, accounting for approximately 85% of the estimated 1.8 million new cases of lung cancer diagnosed each year worldwide. Patients with EGFR Exon20ins+ NSCLC make up approximately 2% of patients with NSCLC.
EGFR Exon20ins+ mutations are different from other common EGFR mutations, changing the shape of the EGFR protein in a way that makes it difficult for traditional EGFR TKIs to effectively target and treat this type of cancer mutation.
Exkivity, taken as four capsules per day at home, is a first-in-class, oral TKI specifically designed to specifically target EGFR Exon 20 insertion mutations.
“This positive recommendation is fantastic news for patients. Particularly as they have previously faced frustration and isolation due to the limited treatment options available for this aggressive disease,” said Angela Terry, chair of EGFR Positive UK.
She continued: “Having a medicine specifically designed to tackle their type of cancer will give patients the much-needed hope of improved outcomes and increased confidence that the management of their disease is catching up with other types of lung cancer.”
The company has a confidential commercial arrangement through a patient access scheme that makes Exkivity available to the NHS with a discount.