Breast Cancer Abstracts

LBA 1001: Trodelvy met the primary endpoint in heavily pretreated HR+/HER2− breast cancer patients in the TROPiCS-02 study

Trodelvy by Gilead Sciences met the primary endpoints in the Phase III trial, reducing the risk of disease progression or death by 30%. Trodelvy was compared to chemotherapy in TROPiCS-02 in third-line HER2−, ER+ breast cancer. It is a big step forward for the anti-Trop-2 antibody-drug conjugate (ADC), which is already licensed for third-line or later triple-negative breast cancer and post-chemo/PD-(L) 1 urothelial bladder cancer. Furthermore, the trial continued to evaluate patients for overall survival, a key secondary endpoint, and the results will be presented on June 4, 2022, at the ASCO 2022 conference in its Oral Abstract Session. It will be interesting to watch the results at the conference, given that Gilead did not give an affirmative answer with regards to the meaningful clinical effects of Trodelvy.

Abstract LBA3: AstraZeneca’s DESTINY Breast04 trial, the first high Phase trial for HER2 low metastatic breast cancer

DESTINY-Breast04 is the first Phase III trial of a HER2-directed therapy in patients with HER2-low metastatic breast cancer to show a statistically significant and clinically relevant improvement in progression-free and overall survival compared to conventional therapy. Trastuzumab deruxtecan is already approved in the US and other countries for the treatment of metastatic HER2+ breast cancer for 3rd line treatment. According to the company, the primary endpoint and the key secondary endpoint are met, and the results are all set to be presented on June 5, 2022, at the ASCO 2022 conference as a Plenary Session. Additionally, in association with Daiichi Sankyo, the company is also presenting the safety follow-up data of the randomized Phase III DESTINY Breast03 trial (Abstract: 1000).

Abstract 1022: Sermonix Pharmaceutical’s lasofoxifene, a potent oral selective estrogen receptor modulator (SERMs), could play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

Lasofoxifene’s bioavailability and action in estrogen receptor mutations could offer promise for patients who have developed endocrine resistance due to ESR1 mutations, which is a common finding in metastatic patients and has an unmet medical need. Sermonix’s lead candidate is currently in Phase II trial. Along with Veru Pharma’s Enobosarm, it is the only emerging SERM in the second-line and the third-line setting, besides the already approved tamoxifen, which has been used for decades. We keenly await the data from the Phase II study, which will be published on June 6, 2022, at the ASCO 2022 conference as a Poster Discussion Session.

Abstract 528: Sanofi’s most anticipated AMEERA-4 is going to present the preoperative window of opportunity (WOO) study in postmenopausal patients with ER+/HER2− primary breast cancer.

With the recent failure of AMEERA-3 and the termination of the AMEERA-4 trial, the company will be presenting its preoperative window for the AMEERA-4 trial on June 6, 2022, at the ASCO 2022 conference as a Poster Session. Due to past disappointments for Sanofi’s oral SERD, this time, it will be intriguing to know the fate of amcenestrant or letrozole in postmenopausal patients with ER+/HER2− primary breast cancer.

Abstract TPS1118: Merck’s KEYNOTE-B49: A Phase III trial in patients with HR+/HER2- locally recurrent inoperable or metastatic breast cancer.

Merck’s top product, Keytruda, combined with chemotherapy, may enhance patient outcomes in HR+/HER2 given that patients with triple-negative breast cancer (TNBC), including those with metastatic disease (KEYNOTE-355) and those with early-stage illness, have shown benefits with Keytruda. However, none of the PD-1 inhibitors till now have been able to make their mark in the breast cancer space. Moreover, this is a trial in progress currently, and we do not expect any significant data readout at this moment.

Abstract TPS1121: Veru’s ENABLAR-2 trial: The first-in-class oral molecule targeting AR+ER+HER2 Breast Cancer

Veru Pharma recently collaborated with Eli Lilly and Company to evaluate enobosarm in combination with Verzenio in the Phase III ENABLAR-2 Trial. The ENABLAR-2 trial will assess the efficacy and safety of the enobosarm and abemaciclib combination in patients who have previously received first-line therapy of palbociclib and estrogen-blocking agent combination in AR+ER+HER2− metastatic breast cancer. Given the Phase II results for ER+ metastatic breast cancer, which had 6-month radiographic progression-free survival of 43.8%, we can expect some positive news from the Phase III results as well.

Abstract TPS1130: CART development in metastatic breast cancer

CAR T (Chimeric antigen receptor T) has proved beneficial for hematological malignancies, as reflected by the successful results of early clinical trials. With more success of CAR-Ts in hematological malignancies than solid tumors, it would be interesting to note their journey for breast cancers. We look forward to the company presenting the insights on June 6, 2022, at the ASCO 2022 conference as a Poster Session.

Abstract 1021: Eli Lilly’s Imlunestrant, an oral SERD for ESR1 mutation in ER-positive (ER+) advanced breast cancer

Eli Lilly is all set to present the monotherapy results from the EMBER trial. Imlunestrant (LY3484356) showed favorable efficacy and pharmacokinetic (PK) properties, including antitumor activity in ESR1 mutants. The initial study results of this trial were presented at ASCO 2021, and the drug had a favorable safety profile. We anticipate the monotherapy to provide positive results on June 6, 2022, as a Poster Discussion Session at the ASCO 2022 conference.

Conclusion

Among numerous trials being presented at ASCO 2022, only DESTINY Breast04 and TROPICS2 caught our attention as their successful completion can enable transformative changes in this segment. In addition, we expect the arrival of novel therapies like CAR T to prove groundbreaking in the coming years. It will be interesting to note the presentation for AMEERA 4 trial by Sanofi after the trial termination. Sermonix has to be one of the lead players this year with lasofoxifene, the only SERM in the second-line and third-line therapy. Apart from these, Ibrance’s PALOMA-2 and PALOMA-3 updated efficacy results are also getting presented.