Matthew Galsky, MD, professor of medicine, hematology, and medical oncology, Mount Sinai Hospital, discusses combination immunotherapy in the treatment of patients with bladder cancer.

Galsky says that a big question in the platinum-resistant setting of metastatic bladder cancer is the use of combination immunotherapy. Data from other solid tumors such as melanoma, kidney cancer, and lung cancer, have shown that combination immunotherapy might increase response rates compared with single-agent therapy. These responses also tend to be quite durable, Galsky explains.

The CheckMate-901 study (NCT03036098) is currently exploring the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) or standard of care versus standard of care alone in patients with previously untreated unresectable or metastatic bladder cancer. Standard of care in this population is a cisplatin-containing regimen. This phase III, randomized, open-label study is a more complex randomization, Galsky says, as it is handled differently based on whether patients are cisplatin-eligible or cisplatin-ineligible.

The primary endpoint of CheckMate-901 is based on the cisplatin-ineligible population, who are being randomized to either nivolumab plus ipilimumab or standard of care cisplatin.

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Matthew Galsky, MD, professor of medicine, hematology, and medical oncology, Mount Sinai Hospital, discusses combination immunotherapy in the treatment of patients with bladder cancer.
 

Dr. Galsky Discusses Combination Immunotherapy in Bladder Cancer

Matthew Galsky, MD, professor of medicine, hematology, and medical oncology, Mount Sinai Hospital, discusses the rationale for the IMvigor130 study in metastatic bladder cancer.

The standard of care for the first-line treatment of patients with metastatic bladder cancer has been chemotherapy for the past several decades, says Galsky. Chemotherapy has a response rate of about 30% to 50% in this patient population. Only a small proportion of patients will have a durable response on cisplatin-based chemotherapy. Historically, there has been no standard of care for patients who progress after first-line chemotherapy.

Galsky says that the introduction of immune checkpoint inhibitors—and their subsequent success in later lines of therapy for bladder cancer&mdash;have raised the question of whether immunotherapy would be effective earlier in the treatment course.

The IMvigor130 trial (NCT02807636) is evaluating first-line atezolizumab (Tecentriq) with or without platinum-based chemotherapy in patients with locally advanced or metastatic bladder cancer. This phase III, randomized study is designed to evaluate the efficacy and safety of atezolizumab alone or with chemotherapy.

Dr. Galsky Discusses the Rationale for the IMvigor130 Study in Bladder Cancer

Matthew Galsky, MD, professor of medicine, hematology, and medical oncology, Mount Sinai Hospital, discusses the next steps following progression on immunotherapy for patients with bladder cancer.

There is a growing understanding of the resistance to checkpoint inhibitors, explains Galsky. One of the main reasons that patients do not respond to checkpoint inhibitors is because their tumors are not immunogenic and have not developed a preexisting immune response, which is necessary.

Dr. Galsky on Progression on Immunotherapy in Bladder Cancer

Matthew Galsky, MD, professor of medicine, hematology and medical oncology, Mount Sinai Hospital, discusses resistance to checkpoint blockade in metastatic bladder cancer.

There is a growing understanding about mechanisms of intrinsic and acquired resistance to checkpoint blockade in metastatic bladder cancer.

The main reason that patients don’t respond to checkpoint inhibitors is still not fully understood, says Galsky.

Matthew Galsky, MD, professor of medicine, hematology and medical oncology, Mount Sinai Hospital, discusses resistance to checkpoint blockade in metastatic bladder cancer.
 

Matthew Galsky, MD

Articles

Dr. Galsky Discusses Combination Immunotherapy in Bladder Cancer

Dr. Galsky Discusses the Rationale for the IMvigor130 Study in Bladder Cancer

Dr. Galsky on Progression on Immunotherapy in Bladder Cancer

Dr. Galsky on Resistance to Checkpoint Blockade in Metastatic Bladder Cancer