Keytruda® Combination Treatment Approved by the European Commission

Last week, it was announced that pembrolizumab (trade name Keytruda®), in combination with chemotherapy drugs, has been approved by the European Commission to be used as the first choice of treatment in certain lung cancer patients.[i]

Keytruda is an immunotherapy cancer drug which has shown promise, in clinical trials, for extending life expectancy in mesothelioma patients. 

Keytruda is already approved for the treatment of several types of cancer in Europe:

  • Melanoma that has spread or cannot be removed with surgery;
  • Squamous or nonsquamous non-small cell lung cancer with high PD-L1 expression, which has spread or is advanced, with no EGFR or ALHK positive mutations, as a first line treatment;
  • Squamous or nonsquamous non-small cell lung cancer with 1% or more PD-L1 expression that has spread or is advanced, in patients who have received at least one prior chemotherapy regimen;
  • Classical Hodgkin lymphoma, after failure of other particular treatments; and
  • Urothelial cancer that is advanced or has spread, in patients who have previously been treated with, or cannot be treated with, particular chemotherapy medicines.

As previously reported, in edition 244 of BC Disease News (here), data from the Phase 3 Keynote-189 trial demonstrated that patients treated with pembrolizumab in combination had significant survival benefits, compared to those treated with chemotherapy drugs alone. This method of treatment was subsequently recommended for approval by the European Medicines Agency (EMA).

The European Commission’s latest approval is therefore based on both Keynote-189 results and the EMA recommendation.

Pembrolizumab, in combination with pemetrexed and platinum chemotherapy, has been approved as a first-line treatment for adult patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), whose tumours have spread and lack mutations (EGFR and ALK).

Treatment can be marketed in all 28 EU member states, as well as Iceland, Lichtenstein and Norway. Approved dosage is 200 mg every 3 weeks, until the disease progresses, or causes significant side effects.

New approvals of the drug may lead to more investigations into drug efficacy with other cancers, or in different groups of patients. This could lead to more evidence in support of effectiveness in mesothelioma patients.

In last week’s edition of BCDN (here), we provided case analysis on Hague v British Telcommunications Plc (Immunotherapy: Reasonableness of Treatment: Private Dictionary Principle) [2018] EWHC 2227 (QB). Here, Master Thornett found that anecdotal evidence, provided by the claimant’s consultant oncologist, in support of a 2nd type of second-line private immunotherapy treatment, was ‘reasonable’. As a result, under a ‘compromise agreement’ the defendant was liable to indemnify the claimant for private therapy, consisting of nivolumab (trade name Opdivo®) and ipilimumab, after pembrolizumab therapy was unsuccessful.

If employers and insurers continue to indmnify mesothelioma claimants for undefined first and second line therapies, it is increasingly likely that successful claims will cover an ever-growing list of drug combinations, including pembrolizumab plus pemetrexed and platinum chemotherapy.

 

[i] European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed and Platinum Chemotherapy for the First-Line Treatment of Patients with Metastatic Nonsquamous NSCLC, with No EGFR or ALJ Genomic Tumor Aberrations.  Merck Newsroom, 10 September 2018. https://www.mrknewsroom.com/news-release/oncology/european-commission-approves-mercks-keytruda-pembrolizumab-combination-pemetre (Accessed 19 September 2018)