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IMFINZITM (durvalumab) WITH CHEMOTHERAPY DEMONSTRATED A SUSTAINED OVERALL SURVIVAL BENEFIT IN 1ST-LINE EXTENSIVE-STAGE SMALL CELL LUNG CANCER IN THE PHASE III CASPIAN TRIAL

AstraZeneca

Data presented at ASCO show 11% of patients on durvalumab plus chemotherapy had not progressed and remained on treatment at two years vs. 2.9% on chemotherapy alone



Luton, UK, 29th May 2020 - Detailed results from an updated analysis of the Phase III CASPIAN trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin, demonstrated a sustained, clinically meaningful overall survival (OS) benefit for adults with extensive-stage small cell lung cancer (ES-SCLC) treated in the 1st-line setting. The data were presented today at the 2020 American Society of Clinical Oncology (ASCO20) Virtual Scientific Program.

The CASPIAN trial met the primary endpoint of OS in June 2019, reducing the risk of death by 27% (equal to hazard ratio [HR] of 0.73; 95% confidence interval [CI] 0.59-0.91; p=0.0047). (1)

After a median follow up of more than two years, the latest results for durvalumab plus chemotherapy showed sustained efficacy, maintaining a 25% reduction in the risk of death versus chemotherapy alone (based on a HR of 0.75; 95% CI 0.62-0.91; nominal p=0.0032).1 Updated median OS was 12.9 months in the experimental arm versus 10.5 months for chemotherapy. (1) In a post-hoc analysis, an estimated 22.2% of patients treated with durvalumab plus chemotherapy were alive at 24 months versus 14.4% for chemotherapy. (1)

For durvalumab plus chemotherapy, 11% of patients were alive and progression-free at 24 months versus 2.9% for chemotherapy (post-hoc). (1) Durvalumab plus chemotherapy maintained a high confirmed objective response rate (ORR) (67.9% versus 58%) and in a post-hoc analysis, duration of response (DoR) for durvalumab plus chemotherapy at 24 months was 13.5% versus 3.9% for chemotherapy. (1) At 24 months, 12% of patients in the durvalumab plus chemotherapy arm remained on durvalumab treatment. (1)

Durvalumab is not currently licensed as a treatment for ES-SCLC in the United Kingdom. In Europe, durvalumab is licensed as monotherapy for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy. (2)

Luis Paz-Ares MD, Ph.D., Chair, Medical Oncology Department, Hospital Universitario Doce de Octubre, Madrid, Spain and principal investigator in the Phase III CASPIAN trial, said: “These updated results from the CASPIAN trial show a remarkable 22.2% of patients still alive at 24 months, supporting the sustained benefits of treatment with durvalumab plus chemotherapy.”

José Baselga, Executive Vice President, AstraZeneca Oncology R&D, said: “After two years median follow-up, durvalumab continues to show sustained and meaningful improvements in survival and prolonged treatment response for patients facing this devastating and aggressive disease.”

The second experimental arm in the CASPIAN trial testing tremelimumab, an anti-CTLA-4 monoclonal antibody, added to durvalumab and chemotherapy showed a trend towards OS, but did not reach statistical significance compared to chemotherapy alone.

The safety and tolerability for durvalumab plus chemotherapy was consistent with the known safety profile of these medicines. Results showed 62.3% of patients experienced a Grade 3 or 4 adverse event (AE) with durvalumab plus chemotherapy (all causes) versus 62.8% with chemotherapy alone. The percentage of patients discontinuing treatment (all causes) was 10.2% for durvalumab plus chemotherapy and 9.4% for chemotherapy alone. Immune-mediated AEs occurred in 20% of patients treated with durvalumab plus chemotherapy, compared to 2.6% with chemotherapy alone. Treatment-related AEs leading to death occurred in 2.3% of patients treated with durvalumab plus chemotherapy, compared to 0.8% with chemotherapy alone. (1)

Durvalumab in combination with etoposide and either carboplatin or cisplatin is currently under regulatory review for the treatment of ES-SCLC in the 1st-line setting in the EU and Japan.

References

1.Paz-Ares L, et al. 9002: Durvalumab ± tremelimumab + platinum-etoposide in first-line extensive-stage SCLC: Updated results from the phase 3 CASPIAN study. Presented at the American Society of Clinical Oncology ASCO20 Virtual Scientific Program on 29 May 2020.
2. IMFINZI 50 mg/mL concentrate for solution for infusion. 16 April 2020. Available at https://www.medicines.org.uk/emc/product/9495/smpc. Accessed May 2020.
3. Cancer Research UK. Lung cancer statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/lung-cancer#heading-One Accessed May 2020.
4. Cancer Research UK. Types of lung cancer. Available at: https://www.cancerresearchuk.org/about-cancer/lung-cancer/stages-types-grades/types Accessed May 2020.
5. National Cancer Institute. NCI Dictionary - Small Cell Lung Cancer. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer Accessed May 2020.
6. Qin A, Kalemkerian GP. Treatment options for relapsed small-cell lung cancer: what progress have we made? J Oncol Pract. 2018:14;369-370.
7. Cancer.Net. Lung cancer - small cell. Available at: https://www.cancer.net/cancer-types/33776/view-all Accessed May 2020.
8. Lassen U, Osterlind K, Hansen M, Dombernowsky P, Bergman B, Hansen HH. Long-term survival in small-cell lung cancer: posttreatment characteristics in patients surviving 5 to 18+ years--an analysis of 1,714 consecutive patients. J Clin Oncol. 1995 May;13(5):1215-20.
9. Stewart R, Morrow M, Hammond SA, et al. Identification and characterization of MEDI4736, an antagonistic anti–PD-L1 monoclonal antibody. Cancer Immunol Res. 2015;3:1052-1062.
10. Patel S, Kurzrock R. PD-L1 expression as a predictive biomarker in cancer immunotherapy. Mol Cancer Ther. 2015;14:847-856.
11. Pakkala S Ramalingam SS.. Personalized therapy for lung cancer: striking a moving target. JCI Insight. 2018;3:e120858.
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