Dec 15, 20224 min read

Another year, another great SABCS!

Wrapping up the year at the San Antonio Breast Cancer Symposium (SABCS) may be one of our favorite things! It’s always great to finish off the year by reconnecting with familiar faces and making new relationships with all the talented SABCS attendees. This year was particularly exciting for MEDSIR as we had 3 of our trials selected for Spotlight Sessions and one poster presentation.

Our onsite experience

Members of the MEDSIR team made their way down to the Lone Star State to meet with investigators and companies and share our innovative company model. We also took advantage of the trip to make sure to discuss some of our ongoing proposals. We can’t wait for you all to see what we have in store for 2023!

Four of our trials were shared at #SABCS22

METALLICA

We were thrilled to share the exciting news of our METALLICA trial during the Spotlight Sessions December 8th with our very own Dr. Antonio Llombart-Cussac on the panel to discuss any questions related to the poster. This trial is assessing the effect of metformin in preventing hyperglycemia in patients with PIK3CA-mutated, HR+/HER2- advanced breast cancer who are being treated with alpelisib plus endocrine treatment (i.e.fulvestrant). The study was broken up into two cohorts; Cohort A included patients who had normal blood glucose levels at baseline and cohort B which included patients who were pre-diabetic. Over the first two cycles, a severe hyperglycemic event was experienced by only 2.1% of patients in cohort A and 15% of patients in Cohort B. This study indicates that metformin can prevent and/or reduce the incidence and severity of all-grade alpelisib induced hyperglycemia. These positive results support a change in clinical practice for PI3CA-mutated HR+/HER2- advanced breast cancer patients receiving alpelisib plus endocrine therapy and demonstrate that addition of metformin could minimize alpelisib adjustments and discontinuations.

Download the poster here.

DEBBRAH

The DEBBRAH trial was selected to be part of the Spotlight Session on Brain Metastases on December 7th with Dr. Marta Vaz-Baptisa on site to answer questions. The trial is evaluating the safety and efficacy of trastuzumab deruxtecan in patients with HER2+ or HER2-low advanced breast cancer with brain metastases and/or leptomeningeal carcinomatosis. During #SABCS22 we shared the results from the subset of patients with HER2-low advanced breast cancer (Cohorts 2 and 4). Specifically, Cohort 2 patients were HER2-low with asymptomatic untreated brain metastases and Cohort 4 patients were HER2 low with progressing brain metastases after local treatment. The primary endpoint of the trial is to assess the intercranial overall response rate. 6 patients were enrolled in each cohort with an intercranial response rate in 66.7% and 33.3% in cohorts 2 and 4, respectively. The median duration of intercranial response was 3.6 months for cohort 2 and 7.8 months for cohort 4. Fatigue and nausea were the most common treatment emergent adverse events and there were two cases of interstitial lung disease/pneumonitis. Overall, trastuzumab deruxtecan shows preliminary activity in pretreated HER2-low breast cancer patients with brain metastases and further investigation with larger cohorts is warranted.

Download the poster here.

PARSIFAL

Exploratory analysis from the PARSIFAL study was also shared in a Spotlight Session on December 8th with Dr. Antonio Llombart-Cussac available for questions. The PARSIFAL study evaluated Palbociclib in combination with either fulvestrant or letrozole in patients with ER+/HER2- locally advanced or metastatic breast cancer. In this analysis, we assessed the impact of proton pump inhibitors on the safety and efficacy of Palbociclib. Protein pump inhibitors are a class of medications that reduce the amount of stomach acid production and are quite frequently given to cancer patients. Interestingly, Palbociclib has been showed to have reduced solubility when gastric pH is > 4.5, a level commonly achieved by protein pump inhibitors. Our analysis suggests that early and sustained coadministration of protein pump inhibitors with Palbociclib and endocrine therapy were associated with lower efficacy but also lower hematological toxicities and dose modifications. While this was non-preplanned analysis, the findings do indicate a pharmacokinetic interaction between Palbociclib and protein pump inhibitors. Further confirmatory studies are needed.

Download the poster here.

OPHELIA

The OPHELIA study was presented during the poster session on December 8th by Dr. José Enrique Alés-Martínez. This study aimed to assess the safety and efficacy of combining Olaparib and trastuzumab in patients with HER2+ germline BRCA mutated (gBRCAm) advanced breast cancer. Designed as a multicenter, investigator-initiated, open-label single arm phase 2 study, the OPHELIA trial enrolled patients with HER2+ locally advanced or metastatic breast cancer that had confirmed deleterious or suspected deleterious gBRCA1/2m that had been treated with one or more systemic regimen including pertuzumab or T-DM1. The primary endpoint was the clinical benefit ratio, with secondary endpoints of overall response rate, maximum tumor reduction, duration of response, and overall survival. The study enrolled 5 patients and was closed due to slow accrual. Of the patients enrolled, 4 out of 5 had a clinical benefit at 24 weeks, with the duration of response of 3.8 months and a 6-month progression-free survival rate of 60%. No unexpected adverse events were found. HER2 overexpression in gBRCAm advanced breast cancer is rare but real-world data should be collected to determine the activity of Olaparib and trastuzumab in these patients.

Download the poster here.

It was great to have such a strong presence from patient advocates!

This year at SABCS there was a large focus on including patient advocates in the program which made for a great conference experience. There were a number of patient advocate talks and sessions, and furthermore, each of the poster spotlight sessions had a patient advocate on the panel. Hearing the perspective of people who are the ones actually receiving the treatments was so powerful and the message was clear: Involving the patient voice is vital in a successful clinical trial.

We still managed to have some fun while working!

Our team worked hard at #SABCS22 but they also managed to fit in some time to have fun! Whether it was catching some of the World Cup 2022 games between meetings and sessions or a night stroll over to the Alamo, our team made the most of the experience. What a great group of people we have a MEDSIR!