Review of Key Opinion Leaders’ Reactions to Trodelvy Approval

2021 Year in Review - Triple-Negative Breast Cancer

Trodelvy (sacituzumab govitecan-hziy) is recommended as a preferred treatment option for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received ≥2 prior systemic therapies, ≥1 for metastatic disease. National Comprehensive Cancer Network guidelines list Trodelvy as a preferred treatment for these patients.1 Trodelvy received regular FDA approval to treat patients with certain unresectable locally advanced or mTNBC in April 2021.1 Since its approval, and following the publication of results from several clinical trials, experts have been commenting on Trodelvy’s importance in treating patients with mTNBC.1

In the ASCENT study, Trodelvy had a 3-times longer median progression-free survival (PFS) than single-agent chemotherapy in the brain metastases–negative (BM-neg) cohort (5.6 months with Trodelvy vs 1.7 months with single-agent chemotherapy).2 Trodelvy had a 1-year longer median overall survival (OS) in the BM-neg population (12.1 months vs 6.7 months with single-agent chemotherapy).2 Eribulin, capecitabine, gemcitabine, or vinorelbine were the single-agent chemotherapy treatments used in the study.2 PFS and OS outcomes were statistically significant in both the BM-neg and whole populations, with 88% of patients in the full group being BM-neg.2 Patients on Trodelvy exhibited no symptoms of their condition worsening for 4.8 months in clinical trials, compared with only 1.7 months for patients on chemotherapy.2 When Trodelvy is compared with chemotherapy, the PFS is almost 3 times higher.2 Neutropenia (51% with Trodelvy and 33% with chemotherapy), leukopenia (10% and 5%), diarrhea (10% and <1%), anemia (8% and 5%), and febrile neutropenia (6% and 2%) were the most common treatment-related side effects of grade ≥3.2

Hope Rugo, MD, breast oncologist at the UCSF Carol Franc Buck Breast Care Center, believes Trodelvy’s approval comes at a very important time, to treat a disease that has the shortest median survival after diagnosis of metastatic disease, and that Trodelvy offers a treatment option for patients with limited alternatives at this late stage of disease.3 Dr Rugo commented that Trodelvy could be a lifeline for some that offers better disease control with reasonable tolerability.3

TNBC has a significant impact on patient health-related quality of life, with those with metastatic disease having worse outcomes than those with other breast cancer subtypes.4 A subanalysis found significant and clinically relevant increases in health-related quality of life with Trodelvy compared with chemotherapy chosen by patients’ physicians.4 At the 2021 European Society for Medical Oncology annual meeting, a subanalysis from the phase 3 ASCENT study was presented comparing the quality-of-life impact in patients treated with Trodelvy compared with a chemotherapy cohort.5 It was found that patients treated with Trodelvy had a lower symptomatic effect of fatigue, pain, and dyspnea than those in the chemotherapy arm.5 The only symptoms that were more prevalent were diarrhea, nausea, and vomiting, which are known side effects of Trodelvy that can be successfully managed in many cases.5 Not only does Trodelvy increase the length of life but it also increases the quality of life.5

Adam Brufsky, MD, of the UPMC Hillman Cancer Center, has also said that patients who have been through multiple rounds of chemotherapy for mTNBC tend to not do well, but patients on the Trodelvy trial did do very well, and while Trodelvy is not a cure, it gives patients improved quality of life.6 Aditya Bardia, MD, from Harvard Medical School, stated that the ASCENT study showed significant improvement in PFS in the Trodelvy group compared with standard chemotherapy. He noted the doubling of OS with Trodelvy therapy and a higher objective response rate with Trodelvy compared with chemotherapy, while being well-tolerated. Dr Bardia believes the study shows that Trodelvy should be considered as the standard treatment for pretreated mTNBC.7

Sara A. Hurvitz, MD, of the University of California, Los Angeles Jonsson Comprehensive Cancer Center, spoke about using Trodelvy in older patients with mTNBC at the 2021 American Society of Clinical Oncology annual meeting.8 Dr Hurvitz spoke of the survival benefit of Trodelvy regardless of age.8 She said, “We have an aging population and cancer is a disease that, at least in breast cancer, increases with age. It is really important for us to look at outcomes based on age.” She added, “I’m reassured that these data show a similar efficacy outcome with the use of sacituzumab as well as a reasonable safety profile. The data will make us all more comfortable offering this therapy that’s associated with a survival benefit to patients, regardless of their age. I’m sure geriatric oncologists applaud this type of analysis.”8

Leading oncologists feel the data are compelling and were impressed that a study involving patients who were pretreated ended with such positive results.9 Breast cancer specialists are looking forward to seeing data on Trodelvy in earlier TNBC and other cancer subtypes, as well as in the neoadjuvant and adjuvant treatment settings.9

References

  1. Breastcancer.org. FDA approves Trodelvy for mTNBC. April 2021. www.breastcancer.org/research-news/fda-approves-trodelvy-for-metastatic-tnbc. Accessed November 15, 2021.
  2. Bardia A, Hurvitz SA, Tolaney SM, et al. ASCENT Clinical Trial Investigators. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med. 2021;384:1529-1541.
  3. Cancernetwork.com. Hope Rugo, MD, on the accelerated approval of sacituzumab govitecan-hziy. April 28, 2020. www.cancernetwork.com/view/hope-rugo-md-accelerated-approval-sacituzumab-govitecan-hziy. Accessed November 15, 2021.
  4. Gilead. TRODELVY significantly improved quality of life over standard of care in 2L+ metastatic triple-negative breast cancer in phase 3 ASCENT study. September 16, 2021. www.gilead.com/news-and-press/press-room/press-releases/2021/9/trodelvy-significantly-improved-quality-of-life-over-standard-of-care-in-2l-metastatic-triplenegative-breast-cancer-in-phase-3-ascent-study. Accessed December 16, 2021.
  5. MedPage Today. Trodelvy improves QOL in triple-negative breast cancer. October 13, 2021. www.medpagetoday.com/meetingcoverage/esmovideopearlsmetbreastca/95007. Accessed November 2021.
  6. Ivanhoe. TNBC: Trodelvy magic bullet. March 18, 2021. www.ivanhoe.com/medical-breakthroughs/triple-negative-breast-cancer-trodelvy-magic-bullet. Accessed November 15, 2021.
  7. YouTube. ESMO 2020 highlights on sacituzumab govitecan in mTNBC: the ASCENT study. www.youtube.com/watch?v=An6I2X3RulM. Accessed November 15, 2021.
  8. Cancer Network. Sara A. Hurvitz, MD, discusses outcomes with sacituzumab govitecan by age for TNBC. August 2021. www.cancernetwork.com/view/sara-a-hurvitz-md-discusses-outcomes-with-sacituzumab-govitecan-by-age-for-metastatic-triple-negative-breast-cancer. Accessed November 15, 2021.
  9. YouTube. Biomarker data from ASCENT trial of sacituzumab govitecan in mTNBC. www.youtube.com/watch?v=72RjuwZ9pXM. Accessed November 15, 2021.

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