Durvalumab (8) – Imfinzi®

a) Female patients with newly diagnosed disease

• The conclusion is that, for the group of patients with a newly diagnosed disease, durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab and olaparib, provides considerable additional benefit.
• The certainty of the evidence for the identified additional benefit is classified as an ‘indication’.
• mortality
  • For the endpoint of overall survival, a statistically significant advantage was observed in the patient population of patients with newly diagnosed disease for durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab and olaparib.
  • The extent of the prolongation in overall survival achieved is assessed as a marked improvement.
• Morbidity – Dyspnoea
  • For the endpoint of dyspnoea (assessed using the EORTC QLQ-C30), a statistically significant disadvantage was observed with durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab plus olaparib.
• Morbidity – loss of appetite
  • For the endpoint of loss of appetite (assessed using the EORTC QLQ-C30), there was a statistically significant disadvantage compared to durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab plus olaparib.
• Morbidity – constipation
  • For the endpoint of constipation (assessed using the EORTC QLQ-C30), there was a statistically significant difference in favor of durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab plus olaparib.
• Morbidity – Patient Global Impression of Severity (PGIS)
  • No statistically significant difference was observed between the treatment groups for symptoms assessed using the PGIS.
• Health-related quality of life – Cognitive functioning
  • For the endpoint of cognitive functioning (assessed using the EORTC QLQ-C30), there was no statistically significant difference between the treatment groups.
• Side effects – severe adverse events (CTCAE grade ≥ 3)
  • For the endpoint of severe adverse events, there was no statistically significant difference between the treatment groups.
• Side effects – Anaemia (severe adverse events)
  • For the endpoint of anaemia (severe adverse events), there was a statistically significant disadvantage for durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab and olaparib, compared with placebo in combination with carboplatin and paclitaxel, followed by placebo.
• Overall assessment
  • In the overall analysis, the clear advantage in terms of overall survival is offset by moderate disadvantages in endpoints within the morbidity category.
  • These disadvantages do not call into question the extent of the improvement in overall survival.
  • No difference relevant to the benefit assessment was identified for the endpoint categories of health-related quality of life and side effects.

b) Patients with recurrent disease

• Consequently, no additional benefit is identified for durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab and olaparib, in patients with recurrent disease.
• mortality
  • In the patient population with recurrent disease, no statistically significant difference was observed between the treatment arms; consequently, no advantage can be inferred here.
• Morbidity – Patient Global Impression of Severity (PGIS)
  • No statistically significant difference was observed between the treatment groups in terms of symptoms assessed using the PGIS.
• Health-related quality of life – Cognitive functioning
  • For the endpoint of cognitive functioning (assessed using the EORTC QLQ-C30), there was no statistically significant difference between the treatment groups.
• Side effects – severe adverse events (CTCAE grade ≥ 3)
  • For the endpoint of severe adverse events, there was no statistically significant difference between the treatment groups.
• Side effects – Anaemia (severe adverse events)
  • For the endpoint of anaemia (severe adverse events), there was a statistically significant disadvantage for durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab and olaparib, compared with placebo in combination with carboplatin and paclitaxel, followed by placebo.
• Overall assessment
  • Overall, no differences relevant to the benefit assessment were observed in the endpoint categories of overall survival, health-related quality of life and side effects.
  • With regard to morbidity, moderate disadvantages are observed.

Courtesy translation only, please refer to the German original.