NICE Recommends Merck's Keytruda in Combination with Chemotherapy for First-Line Treatment of Metastatic Squamous NSCLC

Compiled by Fan Dongdong

Recently, the UK NICE recommended MSD's Keytruda in combination with chemotherapy agents carboplatin and paclitaxel for untreated metastatic squamous non-small cell lung cancer (NSCLC). After receiving NICE's support, MSD's Keytruda has become the first immunotherapy endorsed by NICE that can be used in combination with chemotherapy in a first-line setting, regardless of PD-L1 expression levels.

MSD's Keytruda in Combination with Chemotherapy (Carboplatin and Paclitaxel) Receives Support from UK NICE Mainly Based on Results of Keynote-407 Trial Involving 559 AdultsThe trial results showed that the median survival for patients receiving MSD's Keytruda plus chemotherapy was 15.9 months, compared to 11.3 months for those receiving chemotherapy alone, leading to a 36% reduction in the risk of death. Follow-up data revealed that after 14.3 months of follow-up, the overall survival for patients treated with MSD's Keytruda plus chemotherapy was 17.1 months, while it was only 11.6 months for those receiving chemotherapy alone.

Compared with previous standard treatments, the combination therapy of MSD's Keytruda with chemotherapy drugs carboplatin and paclitaxel offers hope for extending the life expectancy of lung cancer patients. In the UK, there are 48,000 new cases of lung cancer each year. It is the third most common form of cancer and the leading cause of cancer-related deaths, yet only 16% of diagnosed patients survive for five years or longer. As symptoms of lung cancer rarely appear in the early stages, about 75% of patients are diagnosed after the cancer has spread beyond the lungs. Approximately 80% of lung cancer patients have the NSCLC type.

Just a short while ago, in early January, the U.S. FDA granted Fast Track Designation (FTD) to the gene therapy Reqorsa in combination therapy, supporting the use of Reqorsa with MSD's Keytruda to treat patients with histologically confirmed unresectable stage III or IV non-small cell lung cancer (NSCLC). In the first quarter of 2022, Genprex is expected to initiate an open-label, multi-center phase 1/2 clinical trial to evaluate the efficacy and safety of this treatment combination in this patient population.

However, another combination therapy of Keytruda recently encountered a setback. Four years ago, MSD and Eisai signed a cooperation agreement totaling $5.8 billion to jointly develop the oral multi-receptor tyrosine kinase inhibitor Lenvima as a monotherapy and in combination with Keytruda. In December 2021, data presented at the ESMO Immuno-Oncology Congress showed that, in the first-line treatment of non-small cell lung cancer (NSCLC) patients with tumor expression of PD-L1 (CPS≥1%), the combination therapy of Keytruda and Lenvima failed to prolong patient survival compared to Keytruda monotherapy.

So far, after Keytruda was first approved by the U.S. FDA in 2014 for the treatment of advanced melanoma, it has received up to 37 additional indications approvals. Just at the end of December last year, the U.S. FDA approved Keytruda for adjuvant treatment of renal cell carcinoma (RCC) patients with intermediate-high or high risk of recurrence after nephrectomy (surgical removal of the kidney) or nephrectomy and metastasectomy. Keytruda has also become the first immunotherapy approved for adjuvant treatment of renal cell carcinoma post-surgery.

Blockbuster Keytruda's sales soared to $14.4 billion in 2020, and in the first three quarters of 2021, the therapy’s sales reached $12.6 billion. Analysts noted that the total sales of Keytruda therapy for the whole year of 2021 are expected to reach $17 billion.

Reference Source: Merck's Keytruda Scores Key NICE Sign-Off for First-Line NSCLC Indication