LILLY RECEIVES MHRA CONDITIONAL MARKETING AUTHORISATION FOR RETSEVMO®▼ (SELPERCATINIB), THE FIRST THERAPY DEVELOPED TO TARGET RET-DRIVEN ADVANCED LUNG AND THYROID CANCERS

Lilly Receives MHRA CONDITIONAL MARKETING AUTHORISATION For Retsevmo^®▼ (selpercatinib), the First Therapy developed to target RET-Driven Advanced Lung and Thyroid Cancers

·         Retsevmo is an oral therapy, designed to help prevent cancer cells from growing by targeting the specific driver of certain RET-driven advanced or metastatic cancers.[i]^,[ii]

·         In the LIBRETTO-001 Phase 1/2 trial, on which the authorisation is based, in the primary analysis of 105 previously treated patients with NSCLC (non-small cell lung cancer), 64% responded to treatment with an average duration of response of 17.5 months.¹ In the previously treated RET-mutant medullary thyroid cancer patients, the primary analysis of 55 patients demonstrated a 69.1% response rate.¹

BASINGSTOKE, March 10, 2021 – Eli Lilly and Company announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation for Retsevmo^®▼ (selpercatinib) as monotherapy for:

• the treatment of adults with advanced RET fusion‑positive non‑small cell lung cancer (NSCLC) who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy1
• the treatment of adults with advanced RET fusion‑positive thyroid cancer who require systemic therapy following prior treatment with sorafenib and/or lenvatinib1
• the treatment of adults and adolescents 12 years and older with advanced RET‑mutant medullary thyroid cancer (MTC) who require systemic therapy following prior treatment with cabozantinib and/or vandetanib1

Lung cancer is the third most common cancer with 85,000 people in the UK having received a lung cancer diagnosis.^[iii],[iv] Among these patients, NSCLC contributes to 80%-90% of all cases.7^,8 RET fusion-positive tumours occur in 1-2% of NSCLCs and are more commonly found in people who are younger than 60 years.9

There are around 3,700 new thyroid cancer cases in the UK every year, with cases being three times more common in women than in men.^[v] MTC is rare form of thyroid cancer, accounting for approximately 3% of adult thyroid cancers, yet has poorer long-term outcomes compared to other types.^[vi],[vii]

“Lilly is committed to delivering life-changing medicines to people living with cancer and we are delighted that the MHRA has granted conditional authorisation of selpercatinib for people with advanced or metastatic RET-driven lung and thyroid cancers.” said Jyun-Yan Yang, M.D., Senior Medical Director, Northern Europe.  “The development of targeted therapies can offer patients new treatment options with improved outcomes, potentially giving them more time with their loved ones.”

The discovery of genes which can cause lung cancer has led to significant advances in available treatments options. Targeted therapies have the potential to offer improved efficacy and better patient outcomes, while addressing unmet medical needs.^{[viii],[ix],[x]}

Dr Yvonne Summers, consultant oncologist at The Christie NHS Foundation Trust said: “This is good news for patients living with RET-driven cancers as they will soon have a treatment option that targets RET alterations directly.  With trial results showing median benefit of 17.5 months¹, this treatment represents a significant advancement in this growing field.”

The treatment was granted authorisation based on the LIBRETTO-001 Phase 1/2 trial's endpoints of objective response rate (ORR) and duration of response (DoR). Selpercatinib was evaluated in the single-arm, multi-centre Phase 1/2 LIBRETTO-001 trial of over 700 of patients with RET-driven cancers. In the primary analysis of 105 previously treated patients with NSCLC (non-small cell lung cancer), 64% responded to treatment with an average duration of response of 17.5 months.  In the previously treated RET-mutant medullary thyroid cancer patients, primary analysis of 55 patients had a 69.1% response rate.¹

The most common serious adverse drug reactions (ADRs) are hypertension (0.9%), increased aspartate aminotransferase (AST) (1.6%) and increased alanine aminotransferase (ALT) (1.6%). ¹ Permanent discontinuation of selpercatinib for treatment emergent adverse events, regardless of attribution occurred in 6.0% of patients. ADRs resulting in permanent discontinuation (2 or more patients) included increased ALT (0.4%), increased AST (0.3%), hypersensitivity (0.4%), and thrombocytopenia (0.3%).1

[i] Retsevmo (selpercatinib) Summary of Product Characteristics 2021.

^[ii] Drilon A, Hu ZI, Lai GGY, et al. Targeting RET-driven cancers: lessons from evolving preclinical and clinical landscapes. Nat Rev Clin Oncol. 2018;15(3):151-167.

[iii] British Lung Foundation. Lung Cancer Statistics. Available from: https://statistics.blf.org.uk/lung-cancer. Last Accessed: February 2021.

[iv] Office for National Statistics. Cancer registration statistics, England: 2017. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/bulletins/cancerregistrationstatisticsengland/2017#cancer-registration-data. Last Accessed: February 2021.

¹⁵ National Cancer Intelligence Network. Thyroid cancer – trends by sex, age and histological type. Available from: http://www.ncin.org.uk/publications/data_briefings/thyroid_cancer_trends_by_sex_age_and_histological_type. Last accessed: February 2021.

[vi] British Thyroid Association (2014). Guidelines for the management of thyroid cancer. Clinical Endocrinology 81: Suppl 1.

[vii] American Thyroid Association. Medullary thyroid cancer. Available from: https://www.thyroid.org/medullary-thyroid-cancer/. Last accessed: February 2021.

[viii] Penn Medicine. Targeted Molecular Therapy. Available from: https://www.pennmedicine.org/cancer/navigating-cancer-care/treatment-types/targeted-therapy. Last accessed: February 2021.

[ix] Kris MG, et al. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA. 2014;311(19): 1998-2006.

[x] Royal College of Physicians, Care Quality Improvement Department. National Lung Cancer Audit. Spotlight report on molecular testing in advanced lung cancer. 2020. Available from: https://www.rcplondon.ac.uk/projects/outputs/spotlight-audit-molecular-testing-advanced-lung-cancer-2019-diagnoses-2017. Last accessed: February 2021.