ASCO GU Preview: Merck, Bristol-Myers Squibb, Pfizer and More

speaker presenting at audience while audience looks on

The American Society of Clinical Oncology 2019 Genitourinary Cancers Symposium (ASCO GU) is being held in San Francisco from February 14-16. Ahead of the conference, several companies have announced presentations. Here’s a look at just a few.

Merck & Company. Merck plans to present survival data from its pivotal Phase III KEYNOTE-426 clinical trial of its checkpoint inhibitor Keytruda in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of advanced or metastatic renal cell carcinoma (RCC). The company had announced in October 2018 that the trial met both primary endpoints of overall survival (OS) and progression-free survival (PFS), as well as the key secondary endpoint of objective response rate (ORR).

The company will be releasing its first interim analysis, showing that Keytruda with axitinib, compared to Pfizer’s Sutent (sunitinib), significantly improved OS, reduced the risk of death by almost half, as well as PFS and ORR. “Merck is pursuing a broad clinical program in advanced cancers of the kidney, prostate and bladder with the goal of advancing new treatment options for patients afflicted by historically difficult to treat malignancies,” stated Roger M. Perlmutter, President, Merck Research Laboratories.

Merck is presenting more than 20 abstracts at the meeting across its oncology portfolio.

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Bristol-Myers Squibb. Bristol-Myers Squibb is presenting new data from its Phase III CheckMate-214 study. This is a Phase III, randomized, open-label trial evaluating the combination of Opdivo plus Yervoy versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). With a minimum follow-up of 30 months, patients who were intermediate and poor-risk were randomized to receive Opdivo plus low-dose Yervoy. This group continued showing a significant overall survival (OS) benefit compared to those who just received sunitinib. Also, at 30 months, the ORR per investigator for intermediate- and poor-risk patients with the Opdivo-Yervoy combination improved compared to the previous 17.5-month analysis.

“The results from this 30-month follow-up from the CheckMate-214 study are meaningful as they continue to demonstrate that in patients with advanced renal cell carcinoma, a population with considerable unmet treatment needs, there is potential for long-term survival benefits with the combination of nivolumab and ipilimumab,” stated Nizar M. Tanniri, study investigator and physician at The University of Texas MD Anderson Cancer Center.

Pfizer and Astellas Pharma. The two companies plan to present results from the Phase III ARCHES trial in men with metastatic hormone-sensitive prostate cancer (mHSPC). The study evaluated Xtandi (enzalutamide) plus androgen deprivation therapy (ADT), meeting the primary endpoint of significantly reducing the risk of radiographic progression or death by 61 percent compared to ADT alone. Median time to a radiographic progression-free survival (rPFS) was not achieved in the Xtandi plus ADT arm, while median time to an rPFS event in the ADT alone group was 19.4 months.

“The ARCHES trial demonstrated that Xtandi plus standard hormonal therapy delayed disease progression, and if approved, has the potential to be an important treatment option for men with prostate cancer that has spread but has not yet become hormone resistant,” stated Andrew Armstrong, Professor of Medicine, Pharmacology and Cancer Biology, and Director of Research in the Duke Cancer Institute’s Center for Prostate and Urologic Cancers.

The companies are also presenting seven other abstracts evaluating Xtandi at the conference.

Nektar Therapeutics. Nektar indicates it will webcast an analyst and investor conference call at the meeting on Friday, February 15 at 2:00 p.m. Pacific Time. This will follow a presentation of preliminary efficacy, safety and immune monitoring results from its ongoing urothelial carcinoma patient cohort in the PIVOT-02 trial evaluating NKTR-214 (bempegaldesleukin) in combination with Opdivo (nivolumab). NKTR-214 with Opdivo (nivolumab) is being evaluated in a variety of cancers, including melanoma, renal cell carcinoma (both Phase III), and immuno-oncology and urothelial cancer (Phase II). It is also in Phase I trials in combination with Tecentriq (atezolizumab) or Keytruda (pembrolizumab), in combination with NKTR-262, and with Takeda’s TAK-659 in Non-Hodgkin Lymphoma.

NKTR-214 is a CD122-biased agonist that stimulates the patient’s immune system to attack cancer. It is designed to grow specific cancer-killing T-cells and natural killer (NK) cells in the body.

Immunomedics. Immunomedics is presenting updated data with longer follow-up on its sacituzumab govitecan in patients with metastatic urothelial cancer (mUC) who have relapsed or are refractory to chemotherapies and immune checkpoint inhibitors. Sacituzumab govitecan showed an ORR of 31 percent in 45 heavily-pretreated mUC patients, with encouraging median duration of response of 12.6 months and median PFS of 7.3 months.

“Despite the late-stage setting, sacituzumab govitecan continues to show promising activity in patients who failed current standard of care for mUC,” stated Robert Iannone, Head of Research & Development and Chief Medical Officer of Immunomedics. “We believe these results support further investigation in a pivotal Phase II TROPHY U-01 study.”

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