Merck reports positive HRQoL in phase 3 KEYNOTE-024 trial of KEYTRUDA (pembrolizumab)


Merck (MSD) has reported positive health-related quality of life (HRQoL) findings from an exploratory analysis from the phase 3 KEYNOTE-024 trial investigating the use of KEYTRUDA (pembrolizumab) for the treatment of patients with metastatic non-small-cell lung cancer (NSCLC) whose tumours express high levels of PD-L1.

The study is investigating the use of the company’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) compared to standard of care (SOC) platinum-containing chemotherapy for the treatment of patients with NSCLC whose tumours express high levels of PD-L1 (tumour proportion score [TPS] of 50% or more).

In particular, patient-reported outcomes indicated a clinically meaningful improvement with KEYTRUDA compared to chemotherapy.

Merck Research Laboratories senior vice president and therapeutic area head for oncology late-stage development Dr Roger Dansey said: “The patient-reported quality of life outcomes we are seeing in the KEYNOTE-024 study are very encouraging and, coupled with previously reported clinical data from this study, including a survival benefit, are important in understanding the robust clinical profile for KEYTRUDA compared to chemotherapy.”

"Patients were randomised to receive a 200mg fixed dose of KEYTRUDA every three weeks (n=154) or four to six cycles of investigator’s choice platinum-based chemotherapy (n=151)."

German-based LungenClinic Grosshansdorf head of the thoracic oncology department Dr Martin Reck said: “For people living with lung cancer, who often face serious health challenges brought on by the disease, quality of life is a major concern when determining treatment and the data presented today help us further understand the potential clinical benefit for KEYTRUDA in these patients.”

The KEYTRUDA (pembrolizumab) clinical development programme includes more than 30 tumour types in nearly 400 clinical trials, including more than 200 trials that combine KEYTRUDA with other cancer treatments.

Merck has an expansive research programme in NSCLC and is currently advancing multiple registration-enabling studies with KEYTRUDA as monotherapy and in combination with other treatments.

KEYNOTE-024 is a randomised, open-label, phase 3 study investigating KEYTRUDA monotherapy compared to SOC platinum-containing chemotherapy for the first-line treatment of patients with metastatic NSCLC.

The study has seen the enrolment of 305 patients who had not received prior systemic chemotherapy for their metastatic disease and whose tumours had high PD-L1 expression (TPS of 50% or more) with no EGFR or ALK aberrations.

Patients were randomised to receive a 200mg fixed dose of KEYTRUDA every three weeks (n=154) or four to six cycles of investigator’s choice platinum-based chemotherapy (n=151).

The primary outcome measure was progression-free survival.

Key secondary outcomes were overall survival, overall response rate and safety, while exploratory outcomes were duration of response and patient-reported outcomes.