Atezolizumab and Hyaluronidase-tqjs Receives FDA Approval for Subcutaneous Injection
The US Food and Drug Administration (FDA) recently approved the use of atezolizumab and hyaluronidase-tqjs to treat various solid tumors in cancers, including non-small cell lung cancer (NSCLC) and small-cell lung cancer (SCLC). The approval is based on a randomized trial in adults with locally advanced or metastatic NSCLC who were not previously treated with cancer immunotherapy and who had disease progression after treatment with platinum-based chemotherapy.1
The median survival follow-up was 9.5 months, and the median subcutaneous injection time was 7.1 minutes, with an average subcutaneous injection time of 4 to 8 minutes in most patients (76%). Median overall survival (OS) was similar between treatment arms, at 10.7 and 10.1 months in the subcutaneous and intravenous arms, respectively (hazard ratio: 0.88; 95% confidence interval [CI]: 0.67-1.16).2 There were no notable differences observed in overall response rate (ORR), progression-free survival (PFS), or OS between the different formulations.1
The most common adverse reactions of any grade (≥ 10%) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.1 Additionally, most healthcare providers found that subcutaneous administration was convenient (80%), easy to administer (90%), and were satisfied with the treatment (85%).2 Majority of providers (75%) also agreed that administering atezolizumab subcutaneously compared with intravenously could save time.2
Novel ADC Granted Breakthrough Therapy Designation by the FDA for ES-SCLC
The FDA has granted Breakthrough Therapy Designation to the antibody-drug conjugate, HS-20093 for the treatment of extensive-stage small-cell lung cancer (ES-SCLC).3 The designation is designed to help expedite the review process of drugs that demonstrate the potential to treat a serious condition and where preliminary clinical evidence may indicate substantial improvement over currently available therapy.4
The FDA’s decision is based on the data published in the phase I ARTEMIS-001 trial, which showed tumor shrinkage occurring in 96% of patients with evaluable targeted lesions, as well as tumor shrinkage of 50% or more occurring in 44% of patients.3 At the time of data cutoff (November 30, 2023) a total of 56 patients with ES-SCLC were enrolled and received at least one dose of HS-20093, with 31 patients receiving doses at 8 mg/kg and 25 receiving 10 mg/kg once every three weeks.5
Neutropenia, leukopenia, lymphopenia, thrombocytopenia, and anemia were the most common treatment-related adverse events (≥ 10%).5
Resources
- 1. FDA Approves Atezolizumab and Hyaluronidase-tqjs for Subcutaneous Injection
- 2. Burotto M, Zvirbule Z, Alvarez R, et al. Brief Report: Updated Data From IMscin001 Part 2, a Randomized Phase III Study of Subcutaneous Versus Intravenous Atezolizumab in Patients With Locally Advanced or Metastatic NSCLC. J Thorac Oncol. Published online May 9, 2024. doi:10.1016/j.jtho.2024.05.005
- 3. GSK receives US FDA Breakthrough Therapy Designation for its B7-H3-targeted antibody-drug conjugate in relapsed or refractory extensive-stage small-cell lung cancer
- 4. Breakthrough Therapy
- 5. Wang J, Duan J, Sun Y, et al. ARTEMIS-001: data from a phase 1a/b study of HS-20093 in patients with relapsed small cell lung cancer (SCLC). J Clin Oncol. 2024;42(suppl 16):8093. doi:10.1200/JCO.2024.42.16_suppl.8093
