Clinical Trials for new Therapies Providing Hope for Metastatic Breast Cancer Patients

Financialnewsmedia.com News Commentary

PALM BEACH, Florida, June 23, 2020 /PRNewswire/ -- Metastatic breast cancer (also called stage IV) is breast cancer that has spread to another part of the body, most commonly the liver, brain, bones, or lungs. Metastatic disease is NOT hopeless. Many people continue to live long, productive lives with breast cancer in this stage. There are a wide variety of treatment options for metastatic breast cancer, and new medicines and treatments are being tested every day in new clinical trials. More and more people are living life to the fullest while being treated for metastatic breast cancer. While metastatic breast cancer may not go away completely, treatment may control it for a number of years. If one treatment stops working, there usually is another patients can try. The cancer can be active sometimes and then go into remission at other times. Many different treatments — alone, in combination, or in sequence — are often used. According to an article on BreastCancer.org: "Clinical trials are an important step in discovering new treatments for breast cancer and other diseases as well as new ways to detect, diagnose, and reduce the risk of disease. Clinical trials show researchers what does and doesn't work in people. Clinical trials also help researchers and doctors decide if the side effects of a new treatment are acceptable when weighed against the benefits offered by the new treatment." Active biotech and pharma companies in the markets this week include Eli Lilly and Company (NYSE: LLY), Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), Invitae Corporation (NYSE: NVTA), Clovis Oncology, Inc. (NASDAQ: CLVS), Corcept Therapeutics Incorporated (NASDAQ: CORT).

The article continued: "Clinical trials are just one type of research that's done before a new treatment becomes available to people. New medicines must first be discovered, purified, and tested in preclinical trials before researchers even think about clinical trials. According to the American Cancer Society, about 1,000 potential medicines are tested before one makes it to clinical trials. On average, a new medicine to treat breast cancer has been studied for at least 6 years (and sometimes many more) before researchers begin to test it in a clinical trial. An article on UpToDate.com added: "Unfortunately, few if any people with metastatic breast cancer will be cured, meaning that the cancer completely disappears and never comes back. However, there are treatment options that can help (patients) live longer, relieve cancer-related symptoms, and improve your overall quality of life. Many doctors describe this goal as "keeping you feeling as good as you can for as long as you can."

Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS:  Oncolytics Biotech^® Doses First Patient in Phase 2 BRACELET-1 Study Evaluating Pelareorep-Based Combination Therapies in Metastatic Breast Cancer - Oncolytics Biotech^® announced today the first patient has been dosed in the Company's phase 2 study of pelareorep-based combination therapies in HR+/HER2- metastatic breast cancer (mBC). The study, known as BRACELET-1, is being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business in the US and Canada as EMD Serono, and Pfizer Inc. (NYSE: PFE). Participants in the study receive paclitaxel, pelareorep in combination with paclitaxel alone, or pelareorep in combination with paclitaxel and Merck KGaA, Darmstadt, Germany and Pfizer's anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio^®).

The randomized BRACELET-1 study is designed to support the results of a prior successful phase 2 trial (IND-213) that showed a near doubling of overall survival with pelareorep treatment, by demonstrating pelareorep's ability to induce a robust anti-tumor immune response in an identical patient population (patients with HR+/HER2- mBC). The ability of pelareorep-induced immune responses to enhance anti-PD-L1 therapy will also be evaluated through the inclusion of the paclitaxel-pelareorep-avelumab combination therapy cohort. Importantly, the trial also aims to validate peripheral T cell clonality as a biomarker of pelareorep response in HR+/HER2- mBC, which may aid in future registrational trial study design and patient selection.

For more information about the BRACELET-1 study, refer to ClinicalTrials.gov (NCT04215146).

About BRACELET-1  -  The BRACELET-1  (BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti-PD-L1 and Paclitaxel) study is an open-label, phase 2, randomized study in patients with HR+/HER2-, endocrine-refractory metastatic breast cancer being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany and Pfizer. PrECOG LLC, a leading cancer research network, is managing the study. The study will take place at 20 trial sites and enroll 45 patients randomized into three cohorts. A three patient safety run-in will be conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization. The three cohorts will be treated as follows:

-  Cohort 1 (n=15): paclitaxel

-  Cohort 2 (n=15): paclitaxel + pelareorep

-  Cohort 3 (n=18): paclitaxel + pelareorep + avelumab (Bavencio^®)

Patients in cohort 1 will receive paclitaxel on days 1, 8, and 15 of a 28-day cycle. Patients in cohort 2 will receive the same paclitaxel regimen as cohort 1, plus pelareorep on days 1, 2, 8, 9, 15 and 16 of the 28-day cycle. Patients in cohort 3 will receive the same combination and dosing regimen as cohort 2, plus avelumab on days 3 and 17 of the 28-day cycle. The primary endpoint of the study is overall response rate. Exploratory endpoints include peripheral and tumor T cell clonality, inflammatory markers, and safety and tolerability assessments. Read this full press release and more news for ONCY at:  https://www.financialnewsmedia.com/news-oncy/     

Other recent developments in the biotech industry include:

Eli Lilly and Company (NYSE: LLY) recently announced Verzenio® (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) has met the primary endpoint of invasive disease-free survival (IDFS), significantly decreasing the risk of breast cancer recurrence or death compared to standard adjuvant ET alone. These results are from a pre-planned interim analysis of the Phase 3 monarchE study – making Verzenio the only CDK4 & 6 inhibitor to demonstrate a statistically significant reduction in the risk of cancer recurrence for people with high risk hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer. The safety profile was consistent with that observed in other Verzenio studies in the MONARCH clinical program. Lilly plans to present these data at a medical meeting later this year.

"When a person is diagnosed with high risk early stage breast cancer, they strive to do everything in their power to prevent a recurrence. And as clinicians, we have the same goal," said Maura Dickler, M.D., vice president of oncology, late-phase development, Lilly Oncology. "monarchE was intentionally designed for people whose breast cancer is at a high risk of returning. We are incredibly excited by the results of monarchE and that we can potentially offer a new treatment option for patients with high risk HR+, HER2- early breast cancer. This would not have been possible without the tremendous commitment from the people who participated in this trial."

Invitae Corporation (NYSE: NVTA), a leading genetics company, and ArcherDX, a leading genomics analysis company democratizing precision oncology, recently announced the companies have entered into a definitive agreement under which Invitae will combine with ArcherDX to create a genetics leader with unrivaled breadth and scale in cancer genetics and precision oncology.

The combined company will be poised to transform care for cancer patients, accelerating adoption of genetics through the most comprehensive suite of products and services available. Integrating germline testing, tumor profiling and liquid biopsy technologies and services in a single platform will enable precision approaches from diagnostic testing to therapy optimization and monitoring, expanding access to best-in-class personalized oncology.

Clovis Oncology, Inc. (NASDAQ: CLVS) recently announced that four abstracts showcasing non-clinical data from rucaparib and lucitanib development programs have been accepted for on-demand viewing and publication at the upcoming American Association for Cancer Research (AACR) Virtual Annual Meeting II, June 22 - 24, 2020. The accepted abstracts summarize findings from pre-clinical studies evaluating the PK, PD and anti-tumor activity of rucaparib, an oral, small molecule PARP inhibitor in orthotopic and intracranial mouse models, and its synergy with CHK1 inhibition in tumor cell lines. Additional abstracts include findings from a study of the pharmacokinetics of lucitanib, an oral, potent inhibitor of tyrosine kinase activity, in a simulated patient population to inform dosing-regimen selection, and from a pre-clinical study evaluating the anti-tumor efficacy and mechanism of action of lucitanib in combination with a mouse ortholog of ALKS 4230, a selective agonist of the intermediate affinity IL-2 receptor, in a mouse colon cancer model. Lucitanib and ALKS 4230 are both development-stage compounds.

"Data from our ongoing non-clinical studies underscore our commitment to pursuing innovative research that advances novel therapies for cancer patients," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "In particular, we are pleased to present new, non-clinical data exploring the PK/PD of our PARP inhibitor Rubraca, evaluating the synergies of PARP and CHK1 inhibition in combination, as well as important data for lucitanib to understand optimal dosing and use in combination with other anticancer agents to treat solid tumors."

Corcept Therapeutics Incorporated (NASDAQ: CORT),  a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, presented novel genomic data from patients with adrenocortical carcinoma at the 2020 American Association of Cancer Research (AACR) Annual Meeting.

"Excessive cortisol in patients with adrenal cancer causes Cushing's syndrome and may also blunt the efficacy of immunotherapeutic agents such as checkpoint inhibitors," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "The data we are presenting informed our Phase 1b trial of our proprietary, selective cortisol modulator relacorilant in combination with the PD-1 checkpoint inhibitor pembrolizumab (Merck's drug, Keytruda^®) in patients with metastatic or unresectable adrenocortical cancer.¹ Our trial will examine whether relacorilant can, in addition to treating Cushing's syndrome in these patients, also help immunotherapy achieve its maximum effect, by reducing the immunosuppressive effects of excess cortisol activity."

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