PD-L1 Inhibitor Market: Competitive Landscape, Pipeline, and Market Analysis 2024

Programmed death-ligand 1 (PD-L1) also known as cluster of differentiation 274 (CD274) or B7 homolog 1 (B7-H1) is a protein that in humans is encoded by the CD274 gene. Programmed death-ligand 1 (PD-L1) is a 40kDa type 1 transmembrane protein that has been speculated to play a major role in suppressing the adaptive arm of immune systems during particular events such as pregnancy, tissue allografts, autoimmune disease, and other disease states such as hepatitis. The mechanism of action (MOA) of PD-L1 Inhibitor is by binding to PD-L1, the inhibitors prevent its interaction with PD-1, and the binding of PD-L1 to PD-1 receptor on immune cells, such as T cells, inhibits the immune response and promotes immune evasion by cancer cells. PD-L1 inhibitors disrupt this interaction, preventing the inhibitory signal that PD-L1 delivers to PD-1. As a result, the immune response against cancer cells is reactivated. PD-L1 inhibitors are used for the treatment of lymphoma, leukemia, sarcoma, hematologic diseases, glioblastoma, lung diseases, gastrointestinal diseases, colorectal neoplasms, etc. Increased prevalence of sarcoma and lymphoma are the key drivers for the PD-L1 Inhibitor market. For instance, according to the World Health Organization 2023, non-Hodgkin lymphoma (NHL) is one of the most common cancers in the United States, accounting for about 4% of all cancers. Launch of newer products by the market players could seek opportunities that influence extensive research and development in PD-L1 inhibitors. For instance, AstraZeneca’s Imfinzi (Durvalumab) is launched for the treatment of small cell lung cancer. Moreover, the development of novel molecules by many market players is coming up to overcome challenges in therapy. For instance, Sorrento’s Socazolimab (STI-A1014) for the indication of lung cancer is under the various stages of clinical studies.

Key Market Developments:

• In October 2021, Roche received FDA grant for expanded indication for Tecentriq (Atezolizumab as adjuvant treatment following surgery and platinum-based chemotherapy for adults with Stage II-IIIA NSCLC whose tumors express PD-L1≥1%.
• In October 2022, AstraZeneca received FDA approval for its Imjudo (Tremelimumab) Plus Imfinzi (Durvalumab) for the treatment of adult patients with unresectable hepatocellular carcinoma.

Approved Drug Molecules and Brand Names for PD-L1 Inhibitor:

• Tecentriq (Atezolizumab)
• Imjudo (Tremelimumab) Plus Imfinzi (Durvalumab)
• Imfinzi (Durvalumab)
• Bavencio (Avelumab)

Drugs under the Pipeline for PD-L1 Inhibitor:

• Zimberelimab (AB122)
• APL-502
• Adebrelimab (SHR-1316)
• Retlirafusp Alfa (SHR-1701)
• Ezabenlimab (BI 754091)
• Erfonrilimab (KN046)
• Cetrelimab (JNJ-63723283)
• Cejemly (Sugemalimab)
• Socazolimab (STI-A1014)
• Tomivosertib (Eft508)
• PM8002
• IMC-001
• IO102-IO103
• TQB2858
• Nivolumab Subcutaneous (BMS-986298)
• Reozalimab (IBI318)
• Simridarlimab (IBI-322)
• INCB99280
• Emfizatamab (GNC-038)
• Nofazinlimab (CS1003)
• 6MW3211
• BMS-936559
• INCB86550
• PD-L1.T-Hank
• Tecentriq SC (Atezolizumab SC)
• VG161
• Lodapolimab (LY3300054)
• Tagitanlimab (HBM9167)
• LP002
• Cosibelimab (CK-301)
• BC003
• GNC-035
• INCB99318
• IO103
• Acasunlimab (GEN1046)
• Pacmilimab (CX-072)
• BAT7104
• HLX301
• LAE005
• Max-10181

Clinical Activity and Developments of PD-L1 Inhibitor:

Till July 2023, more than 80 companies have approximately 103 molecules targeting the 90 diseases. For these molecules, more than 1600 clinical trials are being conducted and majority are in phase-2, and phase-3 clinical trials by players across the globe. For instance,

• In June 2020, Merck received FDA grant for expanded indication for Bavencio (Avelumab) based on a phase III, multicenter, multinational, randomized, open-label, parallel-arm study investigated first-line maintenance treatment with Bavencio plus BSC versus BSC alone in patients with locally advanced or metastatic UC that did not progress with first-line platinum-containing chemotherapy as per RECIST v1.1.
• In December 2022, Reata Pharmaceuticals completed a phase 3 Study of Bardoxolone Methyl (RTA 402) to evaluate the safety and efficacy in patients with connective tissue disease-associated pulmonary arterial hypertension.