ASCO 2019: Oncology Leaders Select Top Studies

Gina Columbus @ginacolumbusonc
Published: Tuesday, May 28, 2019

Within the week, thousands of abstracts spanning a multitude of tumor types will be presented at the 2019 ASCO Annual Meeting, many of which will lead to practice-changing implications for oncologists. The studies to be unveiled are endless, and cover antibody-drug conjugates, novel targeted agents, and long-term follow-up of currently available therapies.

Ahead of the 2019 ASCO Annual Meeting, we spoke with top leaders in oncology on their thoughts for the most pivotal abstracts being presented in Chicago.

Erika P. Hamilton, MD
Erika P. Hamilton, MD
Erika P. Hamilton, MD, medical oncologist, director, Breast and Gynecologic Cancer Research Program, Sarah Cannon Research Institute

Phase III MONALEESA-7 trial of premenopausal patients with HR+/HER2− advanced breast cancer (ABC) treated with endocrine therapy ± ribociclib: Overall survival (OS) results (Abstract LBA1008)

Based on the progression-free survival (PFS) data from MONALEESA-7, frontline ribociclib (Kisqali) was approved by the FDA for use in combination with an aromatase inhibitor (AI) for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)–positive/HER2-negative advanced or metastatic breast cancer. The agent was simultaneously approved in combination with fulvestrant for the treatment of postmenopausal women with HR-positive/HER2-negative advanced or metastatic breast cancer, in the frontline setting or after disease progression on endocrine therapy.

Prior data of MONALEESA-7 trial showed a median PFS with the combination of ribociclib and an AI of 27.5 months compared with 13.8 months with an AI alone (HR, 0.569; 95% CI, 0.436-0.743). At the 2019 ASCO Annual Meeting, overall survival (OS) findings will be unveiled.

“This presentation is probably my most anticipated of ASCO as we expect to see OS data for the addition of ribociclib to endocrine therapy in premenopausal women. We have all seen the dramatic PFS benefits across multiple trials, but we are really eager to see survival data as it will help us tailor whether we should uniformly be giving CDK4/6s in the first-line setting versus any setting, etc.”

SOPHIA primary analysis: A phase 3 (P3) study of margetuximab (M) + chemotherapy (C) versus trastuzumab (T) + C in patients (pts) with HER2+ metastatic (met) breast cancer (MBC) after prior anti-HER2 therapies (Tx; Abstract 1000)

This is the primary analysis of the randomized, open-label SOPHIA trial comparing the combination of the novel antibody margetuximab and chemotherapy with trastuzumab/chemotherapy in patients with metastatic breast cancer. While OS data are maturing, results showed that the margetuximab regimen improved PFS over trastuzumab with a comparable safety profile.

“This trial tested margetuximab (an Fc-optimized monoclonal antibody against HER2) and chemotherapy versus trastuzumab plus chemotherapy in patients with 1 to 3 prior lines of HER2-[targeted] therapy. We saw the press release with a modest improvement in PFS from 4.9 to 5.8 months (HR, 0.76; P = .333). With many of our effective HER2 agents, such as pertuzumab (Perjeta) and T-DM1 (ado-trastuzumab emtansine; Kadycla) being used in the early-stage space, new HER2 agents are eagerly awaited for patients with metastatic disease.”

Pembrolizumab (P) in patients (pts) with metastatic breast cancer (MBC) with high tumor mutational burden (HTMB): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study (Abstract 1014)

In the phase II basket study, pembrolizumab (Keytruda) was evaluated in a cohort of patients with metastatic breast cancer with high TMB, which ranged from 9 to 37 mutations/megabase. Findings have showed that the disease control rate with pembrolizumab in this cohort is 37% (95% CI, 24%-46%), and the overall response rate (ORR) is 21% (95% CI, 8%-41%). Additionally, the median PFS and median OS is 10.6 weeks and 31.6 weeks, respectively.

“TAPUR studied pembrolizumab in patients with high tumor mutational burden, and among 28 patients with breast cancer who were heavily pretreated (>90% with ≥3 prior systemic regimens) the ORR was 21% and disease control rate (DCR) was 37%. We have to try to put all this in context with the negative pembrolizumab data released in all comers as part of the KEYNOTE-119 trial in the later-line setting, and also the positive data from atezolizumab in the first-line space with IMpassion130, but again, when patients were selected for PD-L1. It may be [that] we need to continue to define our markers of response to who gets benefit—whether it be PD-L1 or TMB.”

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