This recommendation is incredibly important for this patient community in the EU because MPM has had no new treatment developments in the last 15 years and the overall survival rate for the disease is poor.

The Study

This trial demonstrated that the combination therapy could reduce the risk of death by 26% when compared with carboplatin or pemetrexed with cisplatin.

This trial was an open-label investigation which included 605 patients who were all diagnosed with MPM. All patients were randomized to get treated with either the combination therapy, or chemotherapy in combination with pemetrexed plus carboplatin or cisplatin. All patients were given their assigned therapy until their disease progressed, they found the treatment intolerable due to toxicity, or, for those in the immunotherapy group, two years had passed.

The trial’s primary endpoint was overall survival (OS). Also documented were disease control rate, objective response rate (ORR), and progression-free survival (PFS).

For the combination therapy results were as follows.

• Median OS of 18.1 months at the 29.7 month
• 1 year OS rate of 68%
• 2 year OS rate of 41%
• Median DOR 11.0 months
• Medan time to response 2.7 months
• ORR 40%
• Disease Control Rate  77%

The chemotherapy results were as follows.

The same benefits with the combination treatment were found regardless of gender, PD-L1 expression, or non-epithelioid or epithelioid disease.

For those receiving the combination therapy, 30% faced grade 3 or 4 adverse events compared to 32% of patients who were treated with chemotherapy. The most frequent AE’s for the combination therapy group were pruritus and diarrhea.

You can read more about this new recommendation here.