Module 6

02/10/2024

Example: Keytruda (active pembrolizumab) for Cancer Maximise the potential opportunities to extend the medicinal product

Pre-marketing Trial Results: • Keytruda can delay worsening of melanoma and improve survival. • Results from a study of 540 previously treated patients with melanoma showed that 2 years after start of treatment, the disease had not worsened in 16% of patients treated with Keytruda compared with less than 1% of patients treated with chemotherapy. Post-marketing study results to expand the melanoma indication: • A second study looked at 834 patients with melanoma who received either Keytruda or another medicine, ipilimumab. Patients treated with Keytruda lived for up to 5.6 months without their disease getting worse compared with 2.8 months with ipilimumab. In addition, up to 74% of patients treated with Keytruda lived for at least 12 months after the start of their treatment compared with 59% of patients on ipilimumab.

• A third study in 1,019 patients who had surgery and who were at high risk for their cancer coming back compared Keytruda to placebo. After one and a half years of treatment, 72% of patients on Keytruda were still disease-free compared with 54% of patients on placebo.

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 2 – Maintain and Extend the Brand

55

Example: Keytruda (active pembrolizumab) for Cancer Maximise the potential opportunities to extend the medicinal product Post-authorisation: Licence extended to add other multiple new indications at different timepoints to treat earlier, treat new targets and to improve treatment with combination with other actives. • non-small cell lung cancer (NSCLC), a type of lung cancer; 2nd line then later 1st line • classical Hodgkin lymphoma (cHL), a cancer of the white blood cells; monotherapy r&r • urothelial cancer, a cancer of the bladder and urinary tract, • a cancer affecting the head and neck known as head and neck squamous cell carcinoma (HNSCC); monotherapy and then later with combo platinum • renal cell carcinoma (a type of kidney cancer); 1 st line or metastatic then later combo with Lenvatinib • oesophageal cancer (cancer of the gullet or food pipe), including a type of cancer at the junction between the oesophagus and the stomach, • cancer of the colon or rectum (lower part of the gut) that is described as microsatellite in stability high (MSI-H) or mismatch repair deficient (dMMR), • triple-negative breast cancer, • endometrial carcinoma (a cancer of the womb); in combo with Lenvatinib Keytruda mainly used in adults for cancers that are advanced, have spread or returned, are not responding to other treatments or cannot be removed by surgery. For cHL, it is also used in children. In some cancers, it is only given to patients whose tumours produce high levels of a protein known as PD-L1.

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 2 – Maintain and Extend the Brand

56

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