Big Developments Set to be Unveiled at This Year's San Antonio Breast Cancer Symposium (SABCS)

Data published in the SABCS abstract indicates that pelareorep in combination with paclitaxel was safe, well tolerated, and showed anti-tumor activity in Adlai Nortye's single-arm bridging clinical trial in Chinese patients with advanced or metastatic HR+/HER2- breast cancer. As of the abstract's cut-off date, 10 patients were treated, with 4 achieving a partial response (PR) (2 confirmed, 2 unconfirmed), and 5 showing stable disease (SD).

This bridging trial is designed to accelerate Adlai Nortye's development of pelareorep in China by allowing future regulatory submissions to include data from Oncolytics' North American metastatic breast cancer trials, IND-213 and BRACELET-1.

Results from IND-213 showed a statistically significant near doubling of median overall survival in HR+/HER2- breast cancer patients treated with pelareorep plus paclitaxel compared to those treated with paclitaxel monotherapy. BRACELET-1 remains ongoing, with a readout on overall response rate, progression-free survival, and evolving overall survival data from the randomized phase 2 trial expected in the first half of 2023.

As for the AWARE-1 abstract, Oncolytics will be presenting results of gene expression analyses from cohorts 1 and 2, which exclusively enrolled patients with the HR+/HER2- breast cancer subtype who were treated with pelareorep and anti-cancer drug letrozole—with cohort 2 being with the PD-L1 checkpoint inhibitor atezolizumab and cohort 1 being without it.

Results published in the abstract showed that the studied combinations altered tumor microenvironments to induce and enhance anti-tumor immunity.

Biotech giant Eli Lilly and Company (NYSE: LLY) also announced that study investigators will present data from the company's breast cancer portfolio and pipeline at the SABCS, including new results from studies of Verzenio® (abemaciclib; a CDK4/6 inhibitor), imlunestrant (an investigational oral selective estrogen receptor degrader [SERD]), and LOXO-783 (an investigational mutant-selective allosteric PI3Kα H1047R inhibitor).

For the Verzenio oral and poster presentations, LLY will provide updated clinical data from ongoing studies in early and advanced forms of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

Eli Lilly's oral presentation will provide results from a pre-planned overall survival (OS) analysis from the Phase 3 monarchE study in HR+, HER2-, node-positive, high-risk early breast cancer, including four-year efficacy outcomes.

In another spotlight poster discussion, combination therapy results with imlunestrant will also be presented from the Phase 1 EMBER trial of imlunestrant in combination with Verzenio, with or without an aromatase inhibitor, in patients with estrogen receptor positive (ER+), HER2- advanced breast cancer.

In addition, pharmacodynamic data from the preoperative EMBER-2 trial evaluating imlunestrant in ER+, HER2- early breast cancer will be provided. Preclinical data with LOXO-783 in combination with standard-of-care breast cancer agents will also be presented at the meeting.

Oncology testing and global contract research services provider NeoGenomics, Inc. (NASDAQ: NEO) and its liquid biopsy-focused subsidiary, Inivata Limited are set to present new data at the SABCS that supports the use of their personalized, highly-sensitive sequencing test RaDaR® Assay across all types of early breast cancer in both the adjuvant and surveillance settings.

"The data being presented at SABCS adds to the growing body of evidence demonstrating the accuracy of RaDaR in detecting minimal residual disease and early disease relapse," said Vishal Sikri, MBA, President and Chief Commercial Officer, Inivata, and President, Pharma Services, NeoGenomics. "We believe RaDaR offers great promise in breast cancer care as the detection of MRD and recurrence provides critical insights that can significantly impact patient care."

RaDaR detects minimal residual disease (MRD) and recurrence, which are the trace amounts of circulating tumor DNA (ctDNA) that remain after surgery or other cancer treatment.

One study being presented compared the use of RaDaR to digital PCR (dPCR) in the surveillance setting in 161 patients with early-stage triple-negative breast cancer (TNBC). Among ctDNA-positive patients, more than half (55.2%) were first detected by RaDaR versus 5.2% by dPCR.

Clinical stage biopharmaceutical company Zymeworks Inc. (NYSE: ZYME) announced the publication of an abstract for their bispecific antibody zanidatamab, that can simultaneously bind two non-overlapping epitopes of HER2.

In combination with palbociclib and fulvestrant, zanidatamab was well tolerated, with encouraging and durable anti-tumor activity in heavily pretreated patients with HER2-positive HR+ breast cancer.

As per the trial, 34 heavily pretreated patients with HER2-positive HR+ breast cancer were treated with the zanidatamab+Palbociclib+fulvestrant combination, which resulted in a 34.5% confirmed objective response rate, with a 93.1% disease control rate in 29 response-evaluable patients.

Commercial-stage oncology company G1 Therapeutics, Inc. (NASDAQ: GTHX) will also be presenting at SABCS with initial results from its Phase 2 Trilaciclib Mechanism of Action (MOA) Trial, which is a 24 patient trial in early-stage TNBC.

G1 Therapeutics's primary endpoints will assess the immune-based MOA, including the impact of Trilaciclib on CD8+ T cells and regulatory T cells, or Tregs, in the tumor microenvironment.

Secondary endpoints will include pathological complete response (pCR), immune response, and profiling measures. G1 will present initial results from the primary endpoint as a poster presentation during the 2022 SABCS.

For more information please visit: https://usanewsgroup.com/2020/02/24/why-biotechnology-companies-are-so-important/

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