Merck reports that Keytruda (pembrolizumab) as monotherapy is now indicated for the treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have high PD-L1 expression, with no EGFR or ALK genomic tumor aberrations and no prior systemic chemotherapy treatment.

A validated biomarker test to determine a patient’s tumour proportion score (TPS) enables physicians to determine the level of PD-L1 expression on a patient’s tumour cells. A PD-L1 expression on at least 50% of tumour cells (TPS ≥50%) is associated with a higher response rate.4,5

Non-small cell lung cancer is a deadly disease
Lung cancer, which forms in the cells of the lungs,6 is the leading cause of cancer death worldwide.7 The two main types of lung cancer are non-small cell and small cell.6 NSCLC is the most common type of lung cancer, accounting for 80 to 85 percent of all cases.2

The five-year relative survival rate for patients suffering from highly advanced, metastatic (Stage IV) NSCLC is estimated to be one percent.3 On average, 58 Canadians will die from lung cancer every day.1

“NSCLC is an aggressive disease that can affect any Canadian with lungs,” explains Dr. Rosalyn Juergens, Medical Oncologist with the Juravinski Cancer Center in Hamilton, Ontario. “We believe speed and the right diagnostic tools, like the PD-L1 biomarker test, are critical to treating lethal diseases like lung cancer. The key is bringing the right treatment as early as possible to the patients most likely to benefit. For lung cancer patients, it’s critical we avoid losing time on treatments that may not work for them.”

“At Lung Cancer Canada, every day we see how lung cancer shocks, overwhelms and separates families” said Shem Singh, Executive Director, Lung Cancer Canada. “Patients need treatment options in the first line setting that both work and allow them to spend quality time with their families. KEYTRUDA offers this potential for patients meeting the criteria. For this population of patients, every moment counts.”

Our Commitment to Patients
The approval in Canada of this first line indication for KEYTRUDA is a milestone for Merck’s immuno-oncology pipeline. 

“Lung cancer is the leading cause of cancer death for both men and women in Canada,1 which makes this new indication especially significant. We look forward to working with provinces and other jurisdictions to ensure that Canadians who need immunotherapy for first line treatment of metastatic NSCLC have rapid access to KEYTRUDA.” says Chirfi Guindo, President and Managing Director, Merck Canada Inc. “Merck has a long history of bringing innovative treatments to patients suffering from cancer, and we are proud to be at the forefront of this new era in immuno-oncology.”

KEYTRUDA is also approved in Canada for the treatment of metastatic melanoma.

Data Supporting First-Line Approval
The approval was based on data from KEYNOTE-024, a randomized, open-label, phase 3 study evaluating KEYTRUDA monotherapy compared to standard of care platinum-containing chemotherapy for the treatment of patients with both squamous (18%) and non-squamous (82%) metastatic NSCLC. The study enrolled patients who had not received prior systemic chemotherapy treatment for their metastatic disease and whose tumours had high PD-L1 expression (TPS of 50 percent or more) and with no EGFR or ALK aberrations. The study randomized 305 patients to receive KEYTRUDA (200 mg every three weeks) or investigator-choice standard of care platinum-based chemotherapy (pemetrexed+carboplatin, pemetrexed+cisplatin, gemcitabine+cisplatin, gemcitabine+carboplatin, or paclitaxel+carboplatin). Pemetrexed maintenance therapy was permitted for patients with non-squamous histologies.

The primary endpoint was progression-free survival (PFS); additional efficacy outcome measures were overall survival (OS) and overall response rate (ORR). Based on an interim analysis demonstrating KEYTRUDA (pembrolizumab) was superior compared to chemotherapy for both the primary endpoint of PFS and the secondary endpoint of OS, the trial was stopped early in June 2016 to give patients still on chemotherapy the opportunity to receive KEYTRUDA. Findings demonstrated that KEYTRUDA reduced the risk of progression or death by 50 percent compared to chemotherapy (HR, 0.50 [95% CI, 0.37, 0.68]; p<0.001). Additionally, KEYTRUDA resulted in a 40 percent reduction in the risk of death compared to chemotherapy (HR, 0.60 [95% CI, 0.41, 0.89]; p=0.005). 

About KEYTRUDA (pembrolizumab)
The immune system depends on T-cells to find and eliminate cancer cells. Cancer cells on the other hand, have evolved ways to hide from T-cells by sending signals that interfere with their normal function through a protein called PD-1.8 By preventing the PD-1 receptor from binding to its two ligands, KEYTRUDA blocks signals that cancer cells may send, reactivating cancer-specific killer T-cells and restoring the anti-tumour immune response.8

In Canada, KEYTRUDA has been issued marketing authorization without conditions for the treatment of patients with:

  • Unresectable or metastatic melanoma who have not received prior treatment with ipilimumab. Subjects with BRAF V600 mutant melanoma may have received prior BRAF inhibitor therapy.
  • Metastatic NSCLC as monotherapy, in adults whose tumours have high PD-L1 expression (TPS ≥50%) as determined by a validated test, with no EGFR or ALK genomic tumour aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC.

KEYTRUDA has also been issued marketing authorization with conditions, pending the results of studies to verify its clinical benefit for the treatment of patients with:

  • Unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor as per proposed indication.
  • Metastatic NSCLC as monotherapy, in adults whose tumours express PD-L1 (TPS ≥ 1%) as determined by a validated test and who have disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have received authorized therapy for these aberrations prior to receiving KEYTRUDA.8

Merck is advancing a broad and fast-growing clinical development program that has rapidly expanded to encompass more than 30 tumour types in more than 550 clinical trials, of which more than 300 trials combine pembrolizumab with other cancer treatments.

Registration-enabling trials of pembrolizumab are currently enrolling patients in melanoma, NSCLC, head and neck cancer, bladder cancer, gastric cancer, colorectal cancer, esophageal cancer, breast cancer, Hodgkin lymphoma, multiple myeloma and other tumours, with further trials in planning for other cancers. The safety and efficacy of KEYTRUDA for these types of cancer have not been established. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

References: https://www.newswire.ca/news-releases/new-first-line-treatment-now-available-for-canadians-with-metastatic-non-small-cell-lung-cancer-646123133.html