SMC accepts MSD's KEYTRUDA®▼(pembrolizumab) in Combination with Chemotherapy for Restricted Use Within NHS Scotland for First Line Treatment of Adults with Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
Scottish Patients to Access Immunotherapy/Chemotherapy Combination for First-Line Treatment of Advanced Form of Non-Small Cell Lung Cancer
HODDESDON, 9th September, 2019 – Today, MSD (tradename of Merck & Co., Kenilworth, N.J., USA (NYSE:MRK)) is proud to announce that the Scottish Medicines Consortium (SMC) has accepted KEYTRUDA®▼ (pembrolizumab) in combination with carboplatin and paclitaxel chemotherapy for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) for restricted use in Scotland. The SMC has accepted this treatment for patients whose tumours express programmed death ligand 1 (PD-L1) with a <50% tumour proportion score (TPS), or in those whom it has not been possible to evaluate PD-L1 TPS. Treatment with pembrolizumab is subject to a two-year stopping rule.[i]
Now, for the first time, patients with this difficult-to-treat form of lung cancer will have access to pembrolizumab in combination with chemotherapy across the UK – rather than having to wait to finish a course of chemotherapy.i,[ii] This approval makes pembrolizumab the first immunotherapy to be approved for use in the first-line setting for Scottish patients with metastatic squamous NSCLC when combined with carboplatin and paclitaxel chemotherapy.i Pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of metastatic squamous NSCLC in adults.[iii]
“Due to the difficult-to-treat nature of squamous NSCLC, most Scottish patients have, to date, only had access to immunotherapy after chemotherapy,” said Dr Brian Clark, Consultant Clinical Oncologist at the Beatson West of Scotland Cancer Centre. “Treatment with pembrolizumab combined with chemotherapy is showing significant improvements in overall survival and we have found that response rates are significantly higher at 58% with a chemotherapy/immunotherapy combination, compared to 35% for chemotherapy alone. This approval is a hugely positive result for this group of Scottish lung cancer patients, for which this first line treatment option has not been available until now.”
“We are delighted that Scottish patients with squamous NSCLC will now be able to receive pembrolizumab,” said Paula Chadwick, CEO, Roy Castle Lung Cancer Foundation. “From speaking to patients every day, we know the positive impact the new wave of immuno-oncology and targeted therapies are having on their lives. Not only are these treatments potentially giving them more time but also improving the quality of this time with their loved ones.”
Lung cancer is the most common cause of death in both men and women in Scotland. 5,331 cases were diagnosed in 2017 – 16.5% of all cases of cancer diagnosed that year.[iv],[v] It is the leading cause of cancer-related death and, in 2017, accounted for a quarter (25.3%) of deaths caused by all cancers.[vi] The survival rate of lung cancer is poor with 9.8% of Scottish patients still alive five years after diagnosis.vi NSCLC is the most common type of the disease, accounting for more than 80% of cases[vii] and approximately 25-30% of all lung cancers are squamous cell carcinomas.[viii] There are usually no signs or symptoms in the early stages of lung cancer and between 72-76% of people are diagnosed at a late stage (stage III or IV) when the cancer has spread outside the lungs.[ix]
John McNeill, Devolved Nations Director, MSD, said, “As lung cancer is one of the most common cancers in Scotland, we are incredibly pleased that the SMC has recognised the significant value of pembrolizumab in combination with chemotherapy for patients with a notoriously difficult-to-treat form of advanced lung cancer. MSD has worked collaboratively with the SMC and NHS Scotland to broaden access to a beneficial treatment option to another subset of patients with lung cancer which has the potential to increase survival.”
Data from the Phase III KEYNOTE-407 trial supported the decision demonstrating that pembrolizumab in combination with chemotherapy significantly improved overall survival (OS) in adults with metastatic squamous NSCLC regardless of PD-L1 tumour expression status (15.9 months (95% CI, 13.2 months to not reached) vs.11.3 months (95% CI, 9.5-14.8)) and reducing the risk of death by over a third (36%) compared to chemotherapy alone (HR=0.64 [95% CI, 0.49-0.85]; p<0.001).[x]
The safety of pembrolizumab in combination with chemotherapy has been evaluated in 278 patients with squamous NSCLC receiving 200 mg, 2 mg/kg or 10 mg/kg pembrolizumab every three weeks, in clinical studies. In this patient population, the most frequent adverse reactions were anaemia (53.2%), alopecia (46%), and neutropenia (37.8%). Incidences of Grade 3-5 adverse reactions were 69.8% for the pembrolizumab combination and 68.2% for chemotherapy alone. x
[i]Scottish Medicine Consortium. pembrolizumab (Keytruda). Available at: https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-full-smc2187/. Accessed September 2019.
[ii]NICE. Final appraisal document. Pembrolizumab with carboplatin and paclitaxel for untreated metastatic squamous non-small-cell lung cancer. Issued 8th August 2019.
[iii] EMC. KEYTRUDA. Available at: www.medicines.org.uk/emc/product/6947/smpc. Accessed September 2019
[iv]The Scottish Public Health Observatory. Lung Cancer: Key points. Available at: www.scotpho.org.uk/health-wellbeing-and-disease/cancer-lung/key-points/. Accessed September 2019.
[v]Information Services Division. Cancer in Scotland. Available at: https://www.isdscotland.org/Health-Topics/Cancer/Publications/2019-04-30/Cancer_in_Scotland_summary_m.pdf?18:56:50. Accessed September 2019
[vi]The Scottish Public Health Observatory. Lung Cancer: Scottish data. Available at: www.scotpho.org.uk/health-wellbeing-and-disease/cancer-lung/data/scottish/. Accessed September 2019.
[viii]National Cancer Institute. Non-small cell lung cancer. Available athttps://www.cancer.gov/types/lung/hp/non-small-cell-lung-treatment-pdq. Accessed September 2019.
[ix]Cancer Research UK. Lung cancer incidence statistics. Available at: www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/lung-cancer/incidence#heading-Three. Accessed September 2019.
[x]Paz-Ares. L, et al. 2018. Pembrolizumab plus Chemotherapy for Squamous Non–Small-Cell Lung Cancer. N Engl J Med; 379:2040-2051.