Advertisement


Robert Hugh Jones, MD, PhD, on Breast Cancer: Updated Overall Survival Data on Fulvestrant Plus Capivasertib

2022 ASCO Annual Meeting

Advertisement

Robert Hugh Jones, MD, PhD, of Cardiff University and Velindre Hospital, discusses results from an updated analysis of the FAKTION trial, which showed improved overall survival with fulvestrant plus capivasertib in women with metastatic estrogen receptor–positive breast cancer whose disease had relapsed or progressed on an aromatase inhibitor. The benefit may be predominantly in patients with PIK3CA/AKT1/PTEN pathway–altered tumors, a topic researchers continue to study in the phase III CAPItello-291 trial (Abstract 1005).

 



Transcript

Disclaimer: This video transcript has not been proofread or edited and may contain errors.
So the FAKTION trial is a randomized phase two trial that compares the activity of a hormone therapy called Fulvestrant plus capivasertib, which is an AKT inhibitor, compared to Fulvestrant and placebo in patients with oestrogen-receptor-positive, HER2-negative breast cancer, which is incurable. So patients with metastatic disease. and what we did in the first instance is we randomized patients one to one to get either Fulvestrant plus capivasertib or Fulvestrant plus placebo. And in the first instance, we looked at progression-free survival in the intention to treat population. This was reported around three years ago, and it showed that patients who got the capivasertib had a survival or progression-free survival of around about 10.3 months compared to 4.8 months, if you got the Fulvestrant plus placebo. At that time, we did some limited biomarker analysis to see were the patients who had an activated pathway with PI3-kinase mutations were more likely to get benefit from those than those patients that didn't have an activated pathway. At that time, there was no difference between the two groups. So the advantage you couldn't distinguish which patient groups were going to get the most advantage. What we've now done is we've waited some time and done further analysis. So what we are looking at now is overall survival and looking at a more extensive biomarker analysis. And what we found most importantly was patients not only experienced longer time to control their cancer in the capivasertib group, but they had a longer overall survival. So within unselected patient groups that was around about six months, it was 29 months compared with 23 months. But when we did the biomarker analysis, we identified a greater number of patients that had what we call an altered pathway. So around about 54% of patients had an altered pathway. And when we looked at those patients, they were the ones that got the most benefit. So in terms of overall survival, patients with an activated pathway had around about 39 months worth of life. Whereas patients who had an activated pathway, but got placebo only had around 20 months when we looked at the patients that didn't have an activated pathway, there was very little difference between the two groups. So there was no particular benefit in getting the extra capivasertib drug. And what that means is that we can now select patients out who are most likely to benefit from this new treatment. It is a phase two study. So on its own, it won't change practice, but we have right behind it, a phase three study called CAPItello, and that will be looking at a much larger group of patients. And what we can then see is whether this large group of patients get a similar benefit. The other thing to mention is that because FAKTION was recruiting a number of years ago, patients weren't getting CDK4/6 inhibitors before entry into the study standard practice has now changed. And therefore the phase three study that's following on will look at that group of patients that are getting CDK4/6 inhibitors. And therefore it'll be more representative of real life data. We hope the phase three study repeats the incremental benefits that we've seen in the phase two. And that in turn could lead to a change in practice.

Related Videos

Leukemia

Courtney D. DiNardo, MD, MSCE, and Jorge E. Cortes, MD, on CML: New Efficacy and Safety Results for Asciminib

Courtney D. DiNardo, MD, MSCE, of The University of Texas MD Anderson Cancer Center, and Jorge E. Cortes, MD, of Georgia Cancer Center at Augusta University, discuss phase III results from the ASCEMBL trial, which showed that after more than 2 years of follow-up, asciminib continued to yield superior efficacy and better safety and tolerability vs bosutinib in patients with chronic myeloid leukemia (CML) in chronic phase. These results continue to support the use of this kinase inhibitor as a new CML therapy, says Dr. Cortes, with the potential to transform the standard of care (Abstract 7004).

Lung Cancer
Immunotherapy

Rami Manochakian, MD, on NSCLC: Clinical Implications of Findings on Nivolumab Plus Chemotherapy

Rami Manochakian, MD, of Mayo Clinic Florida, discusses the phase II findings of the NADIM II trial, which confirmed that, in terms of pathologic complete response as well as the feasibility of surgery, combining nivolumab and chemotherapy was superior to chemotherapy alone as a neoadjuvant treatment for locally advanced, resectable stage IIIA non–small cell lung cancer (Abstract 8501).

Issues in Oncology
Global Cancer Care

Clifford A. Hudis, MD, and Karen E. Knudsen, PhD, MBA, on How ASCO and the American Cancer Society Are Collaborating to Help Patients With Cancer

Clifford A. Hudis, MD, of the American Society of Clinical Oncology, and Karen E. Knudsen, PhD, MBA, of the American Cancer Society, discuss their collaboration, pooling their research and education resources to help empower patients with cancer and their families. Within 48 hours, Drs. Hudis and Knudsen were able to gear up a rapid response to the crisis in Ukraine, forming a clinical corps of volunteers to post information online in multiple languages, which helped patients navigate their care in the war-torn region. To date, 300 European cancer organizations have joined their efforts.

Gynecologic Cancers

Ursula A. Matulonis, MD, and Domenica Lorusso, MD, PhD, on Gynecologic Cancers: New Findings on Trabectedin vs Clinician’s Choice Chemotherapy

Ursula A. Matulonis, MD, of Dana-Farber Cancer Institute, and Domenica Lorusso, MD, PhD, of Italy’s Gemelli University Hospital, discuss phase III data from the MITO23 trial on single-agent trabectedin vs clinician’s choice of chemotherapy in patients with recurrent ovarian, primary peritoneal, or fallopian tube cancers of BRCA-mutated or BRCAness phenotype. Although trabectedin has demonstrated antitumor activity in relapsed platinum-sensitive disease, it does not appear to improve survival outcomes when compared with standard chemotherapy in the BRCA-mutated population (Abstract LBA5504).

Breast Cancer

Richard Finn, MD, on Advanced Breast Cancer: New Data on Palbociclib Plus Letrozole From PALOMA-2

Richard Finn, MD, of the Geffen School of Medicine at UCLA and the Jonsson Comprehensive Cancer Center, discusses analyses from the PALOMA-2 trial on overall survival with first-line palbociclib plus letrozole vs placebo plus letrozole in women with ER-positive/HER2-negative advanced breast cancer. The study met its primary endpoint of improving progression-free survival but not the secondary endpoint of overall survival. Although patients receiving palbociclib plus letrozole had numerically longer overall survival than those receiving placebo plus letrozole, the results were not statistically significant (Abstract LBA1003).

Advertisement

Advertisement




Advertisement