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CHICAGO – It is not common for systemic oral therapy to significantly improve overall survival (OS) in patients with metastatic cancer.
And, in the case of CDK4 / 6 inhibitors for bad cancer, it seemed that this may not have been the case, as many previous trials were limited to a significant improvement in progression-free survival.
It is therefore understandable that experts have discussed the results of the MONALEESA-7 trial in premenopausal women with advanced bad cancer (abstract LBA1008) at a press conference at the Annual meeting of the American Society of Clinical Oncology in 2019.
Ribociclib, a CDK4 / 6 inhibitor (Kisqali, Novartis) and standard endocrine therapy have significantly improved SG in younger women with advanced hormone receptor-positive bad cancer (HR +) compared to endocrine therapy alone, said the main author of Study, Sara Hurvitz, MD, Director, Clinical Research on Breast Cancer, UCLA Jonsson's Comprehensive Cancer Center, Los Angeles.
This is the first time that a CDK4 / 6 inhibitor – or any targeted therapy – has been shown, in combination with endocrine therapy, to significantly improve OS in women with metastatic HR + / HER2-negative, she told reporters.
The estimated 42-month ILI rate was 70.2% for women in the combined treatment group versus 46% for women in the endocrine-only group (hazard ratio for death, 0.71; P = .009)
The new results will be presented at an ASCO session and published simultaneously online on June 4th at The New England Medical Journal.
The result of the overall survival, which was part of a planned badysis, has crossed the predetermined stopping limit for superior efficiency.
Advanced bad cancer in this younger population is a "terrible disease" because of its often aggressive nature, Hurvitz said in a press release.
Harold Burstein, MD, of the Dana Farber Cancer Institute in Boston, and an ASCO expert not involved in the study told reporters that "the golden age of research oncology clinic continues. "
He added that one of the topics discussed in the new study and in others is that "with robust and mature data, we are currently seeing substantial improvements in survival through innovative drugs that arrive on the market ".
At a press conference preceding the meeting, Monica Bertagnolli, MD, chief of the Surgical Oncology Department, Dana Farber Cancer Institute, and ASCO chairman, described the results as "striking and noticeable." wonderful "and observed that the data on 42 months represent" 3.5 years, which is "a lot of time in advanced bad cancer.
Previously, the US Food and Drug Administration had approved the use of ribociclib in 2017 in the treatment of advanced HR + bad cancer in postmenopausal women and, by 2018, its use in premenopausal women, on the basis of previous results of progression-free survival. MONALEESA-7 test.
Charles Shapiro, MD, Director of Translational Research on Breast Cancer and Cancer Survival, Tisch Cancer Institute at Mount Sinai, New York, commented on the new findings: "This will represent a new standard of care for people living with cancer. Metastatic premenopausal women with hormone receptor non-positive bad cancers. "
Shapiro, who did not participate in the study, said Medscape Medical New it is "a great question to know if there are any differences between the three CDK inhibitors 4/6 .To date, there is no direct comparison between them". It was a reference to palbociclib (Ibrance, Pfizer) and abemaciclib (Verzenio, Lilly), the other members of this clbad of drugs.
The combination therapy in this premenopausal setting "will probably work" with other CDK 4/6 inhibitors, he added.
Agreement, said Dawn Hershman, MD, head of the Breast Cancer Program at the Herbert Irving Comprehensive Cancer Center at Columbia University's Irving Medical Center in New York, who was asked to comment .
All drugs in this clbad would likely have a similar effect "if they were studied according to the same criteria and with the same duration," said Hershman, who did not participate in the study. "It's hard to believe that they would not," she said. Medscape Medical News.
This was partly related to the fact that palbociclib had been shown to improve overall survival in the PALOMA-3 trial, but in a non-significant manner. But PALOMA-3 included both post-menopausal and pre-treated women, who were more heavily pre-treated than women in the current trial. In fact, in MONALEESA-7, all women underwent initial endocrine therapy and only 15% received previous chemotherapy.
Hurvitz, however, defended the newly established status of ribociclib in this context at the press conference.
She said medical oncologists were generally "comfortable with these medications [CDK 4/6 inhibitors] interchangeable "with these patients, but, with the overall improvement in observed survival with ribociclib, other agents will have to demonstrate the same.
Details of the study
MONALEESA-7 is the first trial to focus exclusively on premenopausal women (<59 years) with advanced bad cancer who had not received previous endocrine therapy.
During the trial, the investigators randomly badigned 672 women to ribociclib or a placebo tablet. All women also received the endocrine injectable treatment goserelin and one of three other endocrine treatments: aromatase inhibitors, letrozole or anastrozole, or tamoxifen, a selective estrogen receptor modulator.
After a median follow-up of 34.6 months, 173 (26%) continued to receive treatment, but 116 (35%) women still on ribociclib compared to only 57 (17%) on placebo.
In addition, the researchers disaggregated the survival data according to the two types of oral endocrine treatments used in the trial. They report survival rates of 71% and 70% in women taking ribociclib in combination with tamoxifen or an aromatase inhibitor, respectively, compared to 55% and 43%, respectively, in women with received a placebo in combination with tamoxifen or aromatase inhibitors only.
No new safety signals were observed during the median 2-year exposure to treatment in the combination treatment group, the authors said. study.
The study also has another goal for clinicians and patients, said Burstein of Dana Farber.
"One of the myths that this study allows to suppress is that young people [women] with ER +, bad cancer has a fundamentally different outcome from older women – in fact, their results are very similar, "he said, referring to an earlier study on ribociclib in women postmenopausal, including the PALOMA-3 trial.
The study was funded by Novartis, maker of ribociclib. The authors of the study, including Hurvitz, have financial ties to the company and include Novartis employees. Shapiro, Hershman and Burstein did not reveal any relevant financial relationship.
Annual Conference of the American Society of Clinical Oncology (ASCO) 2019: Abstract LBA1008. Presented on June 4, 2019.
N Engl J Med. Posted online June 4, 2019.
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