Scottish Medicines Consortium Accepts Kite CAR T-Cell Therapy for Earlier Use to Treat Aggressive Blood Cancers

Scottish Medicines Consortium Accepts Kite CAR T-Cell Therapy for Earlier Use to Treat Aggressive Blood Cancers

- First SMC acceptance of any CAR T-cell therapy for lymphoma patients in the second-line setting[i] -

- Axi-cel is now available on the NHS in Scotland for the entire licenced DLBCL population[ii]-

Monday 11^th November 2024, London, UK – Gilead Sciences Ltd. and Kite, a Gilead company, today announced that the Scottish Medicines Consortium (SMC) has accepted the use of its CAR T-cell therapy, Yescarta^® (axicabtagene ciloleucel; axi-cel), for the treatment of adult patients with diffuse large B cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).1 Axi-cel is the first reimbursed CAR T-cell therapy in Scotland for the treatment of adult patients with DLBCL or HGBL who have experienced a relapse within 12 months of completion of their first-line treatment, or did not respond to initial therapy.[ii]

“Blood cancer survival rates in the UK lag behind countries of similar wealth and health and the blood cancer community deserves better. It’s great that people with DLBCL in Scotland now have access to the drug axi-cel on the NHS in this setting, where it is already available in England and Wales. CAR T therapies offer hope to people who are often living with the most aggressive forms of blood cancer, and having earlier access to this innovative drug across the UK is an important step in improving outcomes for patients," said Josh Hill, Scottish Policy Officer, Blood Cancer UK.

With approximately 450 new diagnoses in Scotland each year[iii]*, DLBCL is an aggressive type of non-Hodgkin lymphoma, where abnormal lymphocytes gather in lymph nodes or organs, causing lumps or swellings.[iv] While 50 to 60% of newly diagnosed DLBCL patients respond to initial treatment, 30 to 40% experience relapse, and 10% have refractory disease necessitating alternative treatment options.[v] Traditionally, a stem cell transplant has been the preferred second-line therapy; however, approximately 50% of patients are not eligible and, for those who are, long-term survival and quality of life can be poor.[vi] DLBCL has a 5-year survival rate of 60%, lower than the 70% average for blood cancers overall.[vii]^,[viii]

Peter Wickersham, Vice President and General Manager, Gilead Sciences UK & Ireland, said, "From the first clinical trials, we have been committed to ensuring equitable access to our cell therapies. We are proud to now offer the first cell therapy treatment for patients in a second-line setting in Scotland, including both those eligible and ineligible for stem cell transplant. This news marks a significant step forward for the blood cancer community, as we continue to expand access to innovative cell therapies for patients across the UK.”

The use of axi-cel in the second-line setting was informed by two multicentre, open-label clinical trials; the ZUMA-7 study (n=359) in patients intended for high-dose chemotherapy followed by autologous stem cell transplant and the ALYCANTE study (n=40) in patients deemed ineligible for high-dose therapy and autologous stem cell transplant.[vi]^,[ix] The ZUMA-7 Phase III study showed that axi-cel significantly outperforms standard-of-care (SOC) treatments in relapsed/refractory DLBCL.[x]

In ZUMA-7, the SOC arm received chemoimmunotherapy followed by high-dose therapy/autologous stem cell transplant for patients who achieved a complete or partial remission.[x] Axi-cel demonstrated a superior 24-month event-free survival rate (41% vs 16%; hazard ratio 0.40 p<0.001), improved median progression free survival (14.7 vs 3.7 months) and was the first treatment in nearly 30 years to show statistically significant overall survival improvement in this setting. Among patients who received axi-cel, grade ≥3 cytokine release syndrome occurred in 6%, grade ≥3 neurological events in 21% and one treatment related Grade 5 event.[x]

References

[i] Scottish Medicines Consortium. Yescarta product update SMC2695.

[ii] Yescarta. Summary of Product Characteristics. Updated September 2024. Available at: https://www.medicines.org.uk/emc/product/9439/smpc#gref. Last accessed: November 2024.

[iii] Lymphoma Action. Diffuse Large B-Cell Lymphoma (DLBCL). Lymphoma Action website. Available at:  https://lymphoma-action.org.uk/types-lymphoma-non-hodgkin-lymphoma/diffuse-large-b-cell-lymphoma#what-is. Last accessed: November 2024.

[iv] Blood Cancer UK. What is diffuse large B-cell lymphoma (DLBCL)?. Available at: https://bloodcancer.org.uk/understanding-blood-cancer/lymphoma/diffuse-large-b-cell-lymphoma/what-is-dlbcl/. Last accessed: November 2024.

[v] Raut, L.S. and Chakrabarti, P.P. Management of relapsed-refractory diffuse large B cell lymphoma. South Asian Journal of Cancer, 03(01), pp. 066–070.

[vi] Houot R, Bachy E, Cartron G, et al. Axicabtagene ciloleucel as second-line therapy in large B cell lymphoma ineligible for autologous stem cell transplantation: a phase 2 trial. Nat Med. 2023;29:2593-2601. doi:10.1038/s41591-023-02572-5.

[vii] Blood Cancer UK. Facts and information about blood cancer. Available at: https://bloodcancer.org.uk/news/blood-cancer-facts. Last accessed: November 2024.

[viii] Cancer Research UK. Survival for non-Hodgkin lymphoma. Cancer Research UK. Updated April 2024. Available at: https://www.cancerresearchuk.org/about-cancer/non-hodgkin-lymphoma/survival Last accessed November 2024.

[ix] Westin, J. et al. Survival with Axicabtagene Ciloleucel in Large B-Cell Lymphoma. New England Journal of  Medicine. 2023;389:148-157; DOI: 10.1056/NEJMoa2301665.

[x]Locke, F.L. et al. Axicabtagene CILOLEUCEL as second-line therapy for large B-cell lymphoma. New England Journal of Medicine, 386(7), pp. 640–654.