The Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorisation to Takeda’s EXKIVITY (mobocertinib) for patients in Great Britain with a rare and aggressive form of non-small cell lung cancer (NSCLC).
The authorisation means that EXKIVITY (mobocertinib) will be made available as a treatment for adult patients with epidermal growth factor receptor (EGFR) Exon 20 insertion mutation-positive (Exon20ins+) locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received prior platinum-based chemotherapy.
EGFR Exon20ins+ NSCLC is a rare and specific type of lung cancer that mainly affects younger people and non-smokers. It carries a worse prognosis than other EGFR mutations because of its aggressive nature and there being no targeted treatments on the NHS. Due to the rarity of the disease and the typical patient profile, it can often go undiagnosed for some time meaning most patients are diagnosed at Stage IV.
Mobocertinib was granted an Innovation Passport by the MHRA, enabling its entry into Project Orbis – an initiative organised by the Food and Drug Administration (FDA) which provides a framework for oncology products to be reviewed by international partners. It is designed to get innovative oncology treatments onto market for faster patient access.
Takeda hopes that the approval marks a significant milestone for patients suffering from this disease.
Mobocertinib is a first-in-class, oral Tyrosine kinase inhibitor (TKI) which was granted a conditional marketing authorisation based on a phase I/II multicentre, single-arm, open-label study. The study saw 86 patients with EGFR Exon20ins+ NSCLC who had previously been treated with platinum-based chemotherapy received mobocertinib at a dose of 160 mg once daily until disease progression or intolerable toxicity.
Mobocertinib met the primary endpoint by demonstrating a confirmed objective response rate (cORR) of 26%, as assessed by an independent review committee (IRC) and, in addition, achieved a cORR of 34% as per investigator-assessment. Additional data in 28 platinum pre-treated patients receiving mobocertinib at 160 mg once daily from a phase I/II dose-finding and expansion study demonstrated a 36% cORR, as assessed by an IRC, and 39% as per investigator.
In a pooled analysis of 114 platinum pre-treated patients receiving mobocertinib at 160mg there was a cORR of 28%, a median duration of response of 17.5 months, a median progression free survival of 7.3 months and a median overall survival of 24 months, all assessed by an IRC.
Angela Terry, Chair of EGFR Positive UK commented on the MHRA decision: “The impact of a cancer diagnosis is devastating enough, but to then understand that there are no treatments routinely available for your specific type of disease can often make patients feel frustrated and alone. So, it is fantastic news that EGFR Exon20 insertion NSCLC patients will now have the opportunity to benefit from an oral, targeted treatment that offers the hope of potentially improved outcomes. We also hope that having targeted treatments available will mean that patients are tested more effectively at diagnosis for this specific mutation – something that has historically been quite variable across the country.”
Emma Roffe, Oncology Country Head – UK & Ireland, Takeda UK said: “Takeda is extremely pleased that the promise of mobocertinib has been recognised by the MHRA via Project Orbis, and that approval has been expedited for patients in dire need of targeted treatment options. We have worked in close partnership with the clinical community, the regulatory authority and NHS England to demonstrate the value of this innovative treatment and continue to have patients front of mind in our decision making by ensuring that mobocertinib is made available to patients prior to potential NHS reimbursement later in the year.”