Merck Solidifies RCC Position, While Bristol Gets Good SubQ Readout

Keytruda becomes the first immuno-oncology agent to show an overall survival benefit in adjuvant renal cell carcinoma. Bristol gains ground on Merck and Roche in race to develop a subcutaneous checkpoint inhibitor.

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Merck demonstrates an overall survival benefit with Keytruda in RCC

Merck & Co., Inc. is reinforcing its strength in renal cell carcinoma with data showing an overall survival benefit from the study that earned Keytruda approval in 2021 for adjuvant treatment of clear cell renal cell carcinoma in patients at intermediate-high or high risk of recurrence, but Bristol Myers Squibb Company reported data that same day for its subcutaneous formulation of Opdivo showing non-inferiority to the intravenously infused version now in use.

Key Takeaways
  • Keytruda demonstrates overall survival benefit in post-surgical RCC patients at risk of recurrence.

  • The company hopes to get the Phase III data added to Keytruda’s label in adjuvant clear cell RCC

Both companies released the datasets 27 January at the American Society of Clinical Oncology’s 2024 Genitourinary Cancers Symposium. But while Merck’s data appeared to further shut the door on BMS finding a space in post-surgical RCC, analysts called the data for subcutaneous Opdivo (nivolumab) a positive sign for other companies seeking to develop a subcutaneous injectable of a successful anti-PD-1 or anti-PD-L1 agent. Merck with Keytruda (pembrolizumab) and Roche Holding AG with Tecentriq (atezolizumab) also have subcutaneous reformulation efforts ongoing

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