Opdivo generated KRW 130.4 billion in sales last year, up 18.7% from KRW 109.8 billion in 2022.

After hovering in the KRW 60 billion range from 2019 to 2020, the company surpassed the KRW 100 billion mark in 2022 after reaching KRW 85 billion in 2019.

Together, Keytruda and Opdivo generated KRW 529.1 billion in sales last year, accounting for 72.4% of the market.

Opdivo is a PD-1 class immuno-oncology drug co-developed by BMS and Japan's Ono Pharmaceutical.

It has 22 approved indications in Korea, including melanoma, non-small cell lung cancer, and renal cell carcinoma.

Both companies have been steadily expanding the number of their solid tumor indication since their approval.

In addition to extending Opdivo’s reimbursement coverage, BMS and Ono plan to develop a subcutaneous (SC) formulation to expand options for the patients.

Opdivo's major patents are set to expire in 2028.

BMS confirmed that Opdivo’s subcutaneous (SC) formulation was non-inferior to the intravenous (IV) formulation in a Phase III clinical trial conducted to confirm the efficacy of the SC formulation.

The safety results were also comparable in both arms.

The SC formulation can be administered in less than 5 minutes, compared to the 1 hour required for the existing IV formulation.

BMS is preparing to apply for approval of its SC formulation with regulatory authorities around the world.

Tecentriq and Imfinzi gains ground in intractable cancers Roche's Tecentriq and AstraZeneca's Imfinzi also showed marked sales growth.

After posting KRW 37 billion in 2020 and doubling its sales in 2021, Tecentriq’s sales have been on a steady rise.

Roche has been rapidly expanding Tecentriq’s indication by actively accepting the government’s requests.

Tysentriq gained coverage for lung cancer within a year of approval and expanded coverage in 2019 by removing the PD-L1 expression limit.

Roche plans to expand Tecentriq’s indications through combined use with targeted cancer drugs.

Tecentriq, in combination with Avastin, became the first immuno-oncology drug to be reimbursed for the first-line treatment of liver cancer.

Roche is also conducting combination trials with NT-I7, an anti-interleukin (IL)-7 inhibitor developed by a Korean biotech NeoImmuneTech, in lung and skin cancers.

AstraZeneca's Imfinzi posted sales of KRW 82.7 billion last year, up 57.8% from KRW 52.4 billion in 2022.

After generating KRW 3.4 billion in sales in 2019, Imfinzi’s sales surged 624% to KRW 24.6 billion the following year.

With sales exceeding KRW 80 billion last year, Imfinzi ranked fourth in the immuno-oncology market.

Imfinzi’s strength is that it is the first immuno-oncology drug to show efficacy in biliary tract cancer.

In 2022, AstraZeneca received approval for the Imfinzi+gemcitabine+cisplatin combination in Korea.

This approval established the Imfinzi combination as the new standard of care in biliary tract cancer for 12 years.

AstraZeneca is currently in the process of extending Imfinzi’s reimbursement to its biliary tract cancer indication.

BMS plans to extend indications for the Yervoy+Opdivo combo...Bavencio’s sales increase with reimbursement in urothelial cancer

Sales of Yervoy, which is the only immuno-oncology drug to target CTLA-4, grew only 12.6% last year, generating sales of KRW 16 billion.

In 2021, Yervoy received approval for use in combination with Opdivo in 2021.

However, the maximum dosing interval was set at 2 years, meaning that even if it works, patients will not be eligible for additional reimbursement afterward.

BMS plans to explore multiple uses for the Yervoy and Opdivo combination.

The company is currently exploring the combination of metastatic colorectal cancer, squamous cell carcinoma, and head and neck cancer.

Merck's Bavencio generated KRW 5.7 billion in sales last year.

Sales of Bavencio grew with its reimbursement approval in metastatic urothelial cancer.

Bavencio, which was approved in Korea in 2019, secured reimbursement as a first-line maintenance therapy for urothelial cancer in 2023.

The variable is Padcev.

Padcev, which is an antibody-drug conjugate (ADC) cancer drug developed by Astellas and Seegen, has confirmed efficacy results as a first-line treatment in urothelial cancer.

Based on the results of the study, the company is accelerating its efforts to receive approval as a first-line treatment in urothelial cancer This could have implications for Bavencio, as it is being used as a maintenance therapy in the first-line setting.