ESMO has been an important meeting this year. One practice changing study was presented and some very important clinically-relevant results came out from studies that we contributed to, or led, at UCLA. I have attached the presentations here for you to browse through at your leisure.
- DESTINY-BREAST-03: By far the biggest news of the meeting. Unprecedented PFS improvement with T-DXd (Enhertu) compared to T-DM1 (HR 0.28). ILD rates low with no deaths. These data are immediately practice changing. We co-led this international study.
- Also attached poster showing OS data from DESTINY-Breast 01 presented at ESMO. We also were involved in this study which led to the original FDA approval of this drug.
- MONALEESA-2: First study to show OS benefits with CDK4/6i in frontline setting when combined with an aromatase inhibitor for ER+ metastatic disease. Ribociclib improved survival by more than a year! This is also the longest OS (med OS 63.9 mos) ever reported for metastatic breast cancer. The CDK4/6i story of course began at UCLA. This is the third trial with ribociclib has shown significant OS with ribociclib (MONA-7 and MONA-3). No study has shown significant OS benefit with palbociclib (Ibrance), and one study showed OS benefit with abema.
- coopERA (TRIO-038): (will send you slides tomorrow when embargo lifts) First study to compare a novel oral SERD (giredestrant) to an aromatase inhibitor. Neoadjuvant trial with Ki67 endpoint. We led this study and are presenting results tomorrow. These results support the ongoing trials we have of this drug for hormone receptor positive breast cancer in the adjuvant (lidERA, TRIO-045) and metastatic (perservERA, coming soon) settings.
Other important data to be aware of:
- BRIGHTNESS: EFS data from neoadjuvant study of PARPi and/or platinum in TNBC. Platinum improves pCR and EFS outcomes, PARPi not so much.
- KEYNOTE 522-full presentation of pembrolizumab in neoadjuvant/adjuvant setting for TNBC. Data first presented publicly in July, these are the full data. These led to the FDA approval of this drug for TNBC. Practice changing
- TULIP: Another ADC for HER2+ metastatic breast cancer, trastuzumab duocarmazine. Met its primary endpoint of PFS (2 mo improvement, HR 0.64) but significant toxicity (ocular and lung) with deaths due to toxicity. Not likely practice changing. We shall see.