In May 2017, Keytruda became the fifth immune checkpoint inhibitor to enter the bladder cancer market in just 12 months. Backed by the interim results of its Phase III KEYNOTE-045 trial (NCT02256436), Keytuda is indicated for the treatment of locally advanced or metastatic urothelial carcinoma that has progressed during or after a platinum-containing regimen. Keytruda is the first and only agent to elicit survival improvements over standard chemotherapy. How have these compelling results influenced U.S. oncologists' treatment choice?

At 2018 ASCO Annual Meeting (#ASCO18), the updated results after 2-years follow-up from KEYNOTE-045 confirm Keytruda’s overall survival (OS) benefit over chemotherapy1. Enrolled patients were followed for a median of 27.7 months, and the median OS was 10.3 months with Keytruda versus 7.3 months with investigator’s choice of chemotherapy (paclitaxel, docetaxel, or vinflunine) (HR 0.70; p < 0.0002).

This benefit was seen in all patients regardless of PD-L1 expression subgroups, and the adjustments for multiple variables (age, ECOG PS, prior therapy, liver metastases, baseline hemoglobin, time from last chemotherapy, histology, risk factor group, and choice of chemotherapy) did not change the findings, thus confirming Keytruda’s use as second-line therapy for platinum-refractory advanced urothelial carcinoma.

This long follow-up confirms the overall survival benefit Keytruda offers over chemotherapy in this setting, and reassures its addition as the only subsequent systemic therapy option (post-platinum) with category 1 evidence designation on the NCCN guidelines since May 20172. Unsurprisingly, these results justify oncologists’ preference for Keytruda and its unmatched uptake as second- or later-line therapy for platinum-refractory advanced urothelial carcinoma.

Chemotherapy has been the mainstay of bladder cancer treatment, but the unprecedented and rapid inclusion of five branded immune checkpoint inhibitors—Tecentriq, Opdivo, Imfinzi, Bavencio, and Keytruda—has refreshed the treatment armamentarium for locally advanced or metastatic bladder cancer, making this therapy market dynamic and competitive.

In this fast moving market there are still some key questions that remain to be fully elucidated:

  • How are the immune checkpoint inhibitors faring among each other in this market?
  • What’s driving or precluding choice of therapy?
  • Has Keytruda already or will it soon become the most popular treatment choice for U.S. oncologists?

For the answers to these questions, DRG has its finger on the pulse and offers a variety of syndicated and custom solutions.

  • To understand the market dynamics and how the treatment landscape will evolve over the next ten years across the major markets, look to our Disease Landscape & Forecast
  • Explore in more detail the current treatment landscape through primary market research conducted with U.S. oncologists treating bladder cancer.
  • Find out what the major drivers and obstacles to prescribing are through Current Treatments: Physician Insights and discovers oncologists’ most frequent treatment sequences in commercially important populations and treatment scenarios in our Treatment Sequencing
  • Our monthly updated Real World Brand Tracker service uses real world claims data to help you quickly understand the competitive environment among immune checkpoint inhibitors across oncology indications.

For more insights on oncology drug development, follow @LauraVinuesaDRG


  1. Fradet Y, et al. Pembrolizumab (pembro) versus investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (UC): 2-year follow-up from the phase 3 KEYNOTE-045 trial. J Clin Oncol 36, 2018 (suppl; abstr 4521).
  2. NCCN Guidelines. Bladder Cancer, Version 5.2017, and Version 2.2018.

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