The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recently recommended the approval of three therapeutic approaches, marking significant progress in the treatment of lung cancer, breast cancer, and cervical cancer and offering new hope to patients across Europe.
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Durvalumab for Limited-Stage Small Cell Lung Cancer
On January 30, 2025, durvalumab received a positive recommendation from the CHMP as a monotherapy for adults with LS-SCLC whose disease has not progressed following platinum-based chemoradiation therapy (CRT). This decision is supported by results from the ADRIATIC Phase III trial, published in The New England Journal of Medicine.
Key findings include:
- 27% reduction in the risk of death compared to placebo (HR = 0.73; 95% CI: 0.57-0.93; p = 0.0104).
- Median overall survival (OS) of 55.9 months for durvalumab vs. 33.4 months for placebo.
- At three years, 57% of patients treated with durvalumab were alive, compared to 48% in the placebo group.
- 24% reduction in the risk of disease progression or death (PFS HR = 0.76; 95% CI: 0.61-0.95; p = 0.0161).
- Median progression-free survival (PFS) of 16.6 months for durvalumab vs. 9.2 months for placebo.
These results highlight durvalumab’s potential to extend survival and delay disease progression in LS-SCLC patients.
Tisotumab Vedotin for Recurrent or Metastatic Cervical Cancer
Also on January 30, 2025, tisotumab vedotin was recommended for approval for the treatment of recurrent or metastatic cervical cancer. Tisotumab vedotin, an antibody-drug conjugate, targets tissue factor (TF)-expressing tumor cells, leading to cell death.
The recommendation is based on data from the innovaTV 301 Phase III trial, which demonstrated:
- 30% reduction in the risk of death compared to chemotherapy (HR = 0.70; 95% CI: 0.54-0.89; p = 0.0038).
- Median OS of 11.5 months for tisotumab vedotin vs. 9.5 months for chemotherapy.
- Secondary endpoints, including PFS and ORR, were also met.
Tisotumab vedotin showed no new safety issues, with common adverse reactions including peripheral neuropathy, nausea, conjunctivitis, and anemia.
Datopotamab Deruxtecan (Dato-DXd) for HR-Positive, HER2-Negative Breast Cancer
On January 31, 2025, the CHMP recommended approval of datopotamab deruxtecan (Dato-DXd) for adults with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have undergone endocrine therapy and at least one line of chemotherapy.
Based on the TROPION-Breast01 Phase III trial, published in the Journal of Clinical Oncology, the key outcomes were:
- 37% reduction in the risk of disease progression or death compared to chemotherapy (HR = 0.63; 95% CI: 0.52-0.76; p < 0.0001).
- Median PFS of 6.9 months with Dato-DXd vs. 4.9 months with chemotherapy.
- Objective response rate (ORR) of 36% with Dato-DXd vs. 23% with chemotherapy.
- Median duration of response (DoR) of 6.7 months for Dato-DXd compared to 5.7 months with chemotherapy.
Dato-DXd also demonstrated a favorable safety profile, with fewer grade 3 or higher treatment-related adverse events (21% vs. 45% with chemotherapy), offering a promising option for patients with advanced breast cancer.
These CHMP recommendations highlight the continuous advancements in oncology, offering new, effective treatment options for patients with lung, breast, and cervical cancers. As these therapies move closer to receiving full marketing authorization in the EU, they promise to improve survival outcomes and quality of life for many patients across Europe.
References:
- “Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025 | European Medicines Agency (EMA),” European Medicines Agency (EMA), Jan. 31, 2025. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-27-30-january-2025#positive-recommendations-on-new-medicines-73281
- Y. Cheng et al., “Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer,” New England Journal of Medicine, vol. 391, no. 14, pp. 1313–1327, Sep. 2024, doi: 10.1056/nejmoa2404873.
- I. B. Vergote et al., “LBA9 innovaTV 301/ENGOT-cx12/GOG-3057: A global, randomized, open-label, phase III study of tisotumab vedotin vs investigator’s choice of chemotherapy in 2L or 3L recurrent or metastatic cervical cancer,” Annals of Oncology, vol. 34, pp. S1276–S1277, Oct. 2023, doi: 10.1016/j.annonc.2023.10.029.
- A. Bardia et al., “Datopotamab Deruxtecan versus chemotherapy in previously treated Inoperable/Metastatic hormone Receptor–Positive Human Epidermal Growth Factor Receptor 2–Negative breast cancer: primary results from TROPION-Breast01,” Journal of Clinical Oncology, Sep. 2024, doi: 10.1200/jco.24.00920.
Nuria María Novoa
