Dr. Konstantinopoulos on the Phase III Results of the JAVELIN 200 Trial in Ovarian Cancer

Panagiotis A. Konstantinopoulos, MD
Published: Wednesday, Jan 16, 2019



Panagiotis A. Konstantinopoulos, MD, director, Translational Research, Gynecologic Oncology, Dana-Farber Cancer Institute, associate professor of medicine, Harvard Medical School, discusses the disappointing results of the JAVELIN 200 trial in ovarian cancer.

In November 2018, Merck KGaA and Pfizer announced that the combination of avelumab (Bavencio) and doxorubicin failed to meet the predetermined endpoints of overall survival (OS) and progression-free survival (PFS). The study randomized patients with platinum-resistant and platinum-refractory disease to avelumab alone, avelumab plus doxorubicin, or doxorubicin alone.

Avelumab monotherapy induced a response rate of 3.7%, which stands in contrast to the 9.7% response rate observed in a single-agent study presented at the 2016 ASCO Annual Meeting. Similarly, the response rate with doxorubicin was lower than what has been observed as a single agent. Though the objective response rate of the combination was higher than either therapy alone, it did not translate to a statistically significant improvement in PFS and OS, says Konstantinopoulos.

However, negative studies or studies with modest response rates should not deter physicians from pursuing combinations with immunotherapy when there is a strong rationale behind them, states Konstantinopoulos.
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Panagiotis A. Konstantinopoulos, MD, director, Translational Research, Gynecologic Oncology, Dana-Farber Cancer Institute, associate professor of medicine, Harvard Medical School, discusses the disappointing results of the JAVELIN 200 trial in ovarian cancer.

In November 2018, Merck KGaA and Pfizer announced that the combination of avelumab (Bavencio) and doxorubicin failed to meet the predetermined endpoints of overall survival (OS) and progression-free survival (PFS). The study randomized patients with platinum-resistant and platinum-refractory disease to avelumab alone, avelumab plus doxorubicin, or doxorubicin alone.

Avelumab monotherapy induced a response rate of 3.7%, which stands in contrast to the 9.7% response rate observed in a single-agent study presented at the 2016 ASCO Annual Meeting. Similarly, the response rate with doxorubicin was lower than what has been observed as a single agent. Though the objective response rate of the combination was higher than either therapy alone, it did not translate to a statistically significant improvement in PFS and OS, says Konstantinopoulos.

However, negative studies or studies with modest response rates should not deter physicians from pursuing combinations with immunotherapy when there is a strong rationale behind them, states Konstantinopoulos.



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