Lung Metastases Imaging: Practice Essentials, Radiography, Computed Tomography
BriaCell Reports Positive Overall Survival (OS) In Metastatic Breast Cancer
PHILADELPHIA and VANCOUVER, British Columbia, Sept. 11, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is pleased to announce positive overall survival data of its Phase 2 clinical study of Bria-IMT™ in combination with an immune check point inhibitor (CPI) in late stage metastatic breast cancer.
Median overall survival of 15.6 months is reported in BriaCell's most recent patients (treated since 2022) vs. 6.7-9.3 months for similar patients reported in the literature (see table below). These patients are being treated with the same Bria-IMT™ formulation currently being used in BriaCell's ongoing Phase 3 pivotal study in metastatic breast cancer (listed on ClinicalTrials.Gov as NCT06072612) and represent patients enrolled post-COVID when full study activities resumed.
This represents a substantial improvement over BriaCell's 13.4 months median overall survival previously reported in December 2023.
"Overall survival in patients with heavily pre-treated metastatic breast cancer is very poor," stated Sara A. Hurvitz, MD, Professor of Medicine, Fred Hutch Cancer Center and University of Washington and BriaCell medical advisory board member. "The BriaCell early data is quite encouraging from both efficacy and tolerability standpoints."
"We wanted to look at the Phase 2 data of those patients who most closely resemble the patients being treated in our ongoing phase 3 study and compare them to similar patients in the literature," stated Dr. William V. Williams, BriaCell's President and CEO. "The nearly two-fold overall survival benefit we are seeing with the Bria-IMT™ regimen, together with the similar previously reported approximate doubling of progression free survival, compared with literature controls, strongly support our belief that Bria-IMT™ could have a meaningful impact in the lives of heavily pre-treated metastatic breast cancer patients. We look forward to further clinical development of Bria-IMT™ with the goal of establishing it as a new standard of care for patients with metastatic breast cancer."
"The Bria-IMT™ regimen is the only investigational drug we have seen to show these impressive survival numbers in heavily pre-treated metastatic breast cancer patients who have failed numerous prior treatments including immune check point inhibitors and antibody drug conjugates," stated Giuseppe Del Priore, MD, MPH, BriaCell's Chief Medical Officer. "These survival and clinical benefit data support BriaCell's hypothesis of additive and/or synergistic effects of immune check point inhibitors with Bria-IMT™ and drive the ongoing pivotal study of our combination regimen in the treatment of metastatic breast cancer."
The Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (average number of prior treatments = 6) who were treated with the Bria-IMT™ regimen and an immune checkpoint inhibitor. Of these 54 patients, 37 were treated with the Phase 3 formulation and 25 of these were treated post-COVID when full study activities resumed. This data represents an additional six months of follow-up of the survival data presented at the San Antonio Breast Cancer Symposium in December 2023.
Table 1. Comparative Median Overall Survival (OS) and Progression-Free Survival (PFS) in Similar Patients (Interim Analysis Using Kaplan-Meier Estimate) Study Prior Linesof Therapy(median, range) NumberofPatients OS(months) PFS(months) BriaCell's Phase 2 study patients who received pivotal Phase 3 study formulation (since 2022) 5.5 (2-13) 25 15.6 4.1 BriaCell's Phase 2 study patients who received pivotal Phase 3 study formulation (total) 6 (2-13) 37 13.4 3.9 Bardia, A. Et. Al. 1 (TNBC) 4 (2-14) 262 6.9 1.7 Tripathy D. Et. Al. 2 (Brain metastases) ≥4 in 91% 178 7.5-7.8 1.9-2.8 O'Shaughnessy J. Et. Al. 3non-TNBC at initial diagnosis 5 (2-14) 76 6.7 2.3 O'Shaughnessy J. Et. Al. 3TNBC at initial diagnosis 4 (2-10) 157 6.9 1.6 Cortes et. Al. 4 4 (0-13) 594 9.1-9.3 1.9-2.5References
About BriaCell Therapeutics Corp.
BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.Com/.
Safe Harbor
This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including statements about: the impact of Bria-IMT™ on patients with metastatic breast cancer; BriaCell's further clinical development of Bria-IMT™; and the efficacy of immune check point inhibitors, are based on BriaCell's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading "Risks and Uncertainties" in the Company's most recent Management's Discussion and Analysis, under the heading "Risk Factors" in the Company's most recent Annual Information Form, and under "Risks and Uncertainties" in the Company's other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR+ at www.Sedarplus.Ca and on EDGAR at www.Sec.Gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. Undertakes no duty to update such information except as required under applicable law.
Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.
Contact Information
Company Contact:William V. Williams, MDPresident & CEO1-888-485-6340info@briacell.Com
Media Relations:Jules AbrahamCORE IRjulesa@coreir.Com
Investor Relations Contact:CORE IRinvestors@briacell.Com
What Is Metastatic Cancer?
Metastatic cancer is cancer that has spread from its original location to a distant part of the body. Most metastatic cancers are not curable, but people with well-controlled metastatic cancer can live for many years.
Metastatic cancers are serious and difficult to treat. While most are incurable, they can be managed for months or even years with the right treatment. And certain kinds of metastatic cancer, such as testicular cancer, can be curable.
This article takes a closer look at metastatic cancers, where they're likely to spread, and why the outlook for people with metastatic cancers can vary so much.
The first cancerous tumor that develops is the primary tumor. Eventually, this tumor can grow big enough to push into nearby tissue and organs. Cells can also break away from the tumor and spread through tissue to form new tumors in nearby tissues, organs, or lymph nodes.
Cancer cells can also enter your bloodstream or lymphatic system. From there, they can travel just about anywhere in your body. When tumors form in a distant part of your body, you have metastatic cancer.
Therefore, metastatic cancer is cancer that has spread from the original tumor to a distant part of the body in any of these ways. However, it is also possible to develop cancer metastasis without an obvious primary tumor. This usually happens when the primary tumor is too small or too difficult to detect on imaging.
Cancer can spread almost anywhere, but different types of cancer tend to spread to certain places. The following chart shows the most common sites of metastasis for each type, according to the National Cancer Institute:
As of 2018, just over 600,000 Americans were living with metastatic lung, colorectal, bladder, or skin cancer, and this number is expected to rise by 2025.
However, any cancer can metastasize, and metastasis can be a key cause of death from cancer. Together, the following cancers are responsible for almost 50% of all cancer deaths:
What is the life expectancy of metastatic cancer?
The outlook depends on many things, including the specific type of cancer. For example, research from 2017 looked at survival after bone metastasis by primary cancer type.
Follow-ups at 1 and 5 years suggest that people with bone metastasis from breast cancer have a better outlook than people with bone metastasis from lung cancer.
Other factors that can influence survival rates are:
Survival rates vary for different types of cancer. The following are the 5-year relative survival rates for several types of cancer that were metastatic at diagnosis:
Keep in mind that these are general statistics, and your doctor will be able to offer a more personal outlook.
What stage is metastatic cancer, and is it terminal?
Certain types of cancer are considered stage 4 cancer, which can often lead to death.
A 2024 study examined the causes of death for people living with metastatic cancer, examining 13 types of cancer and 25 non-cancer factors. Looking at the chance of death from specific cancer compared to other causes in more than a million Americans between 1992 and 2019, researchers found that 82.6% of people died due to their cancer, while 17.4% died from other causes. On average, those living with metastases had a survival time of only ten months.
That said, whether or not metastatic cancer is life threatening depends on the type of cancer, and cancer doesn't need to metastasize in order to be considered advanced or end stage. For example, some large brain tumors may be advanced even though they have not spread beyond the brain. This makes the cancer life threatening even without metastasis.
Conversely, metastatic cancers aren't necessarily advanced. For example, testicular cancer can spread but still be very curable. In certain cases of incurable cancer, people with well-controlled metastasis can live for many years.
Cancer is harder to treat once it spreads beyond the original site. Because every type of metastatic cancer is different, treatment options vary.
The main treatments are based on the specific type of cancer, which refers to where the cancer started, not where it has spread to. For example, colon cancer that spreads to the liver is treated as colon cancer, not liver cancer.
Other factors that affect treatment options are:
In some cases, the goal of treatment may be to cure the cancer or slow it down. In others, you may want to focus on symptom relief and quality of life. You can always receive palliative care along with other treatments.
Doctors will help determine the best treatment plan based on the specifics of your situation and your preferences.
How do I cope with metastatic cancer?
Living with metastatic cancer is unique to each individual and can be challenging. It can help to speak with your oncologist about your treatment options, goals, and managing symptoms. This will help you understand what to expect and make informed decisions about your care. Since having cancer can destress, it is also important to work on your mental health through support from loved ones, counselors, and community programs.
Can chemo stop metastatic cancer?
Chemotherapy can kill cancer cells that have spread beyond the primary tumor. However, this doesn't always mean that the cancer will be cured or stop metastasizing. Some cancers may go into remission, others may require chronic treatment, and while others may be untreatable.
How does metastatic cancer cause death?
The spread of cancer cells can disrupt the operation of vital organs. Depending on the cancer and where it spreads, this can affect your digestion, respiration, skeletal structure, liver function, blood vessels, and more. Ultimately, it can result in the failure of crucial bodily functions, which can lead to death.
What is the difference between metastases and metastasis?
Metastasis can be used generally as part of "cancer metastasis' to refer to cancer that has spread. Specifically, however, metastases are the plural form of metastasis.
Metastatic cancer is cancer that has spread from its primary site to a distant part of the body. For many types of cancer, "metastatic" refers to stage 4 cancer. Metastatic cancer is often treatable, though it's challenging.
Most metastatic cancers are not curable, but it's possible to live for many years with metastatic cancer if the disease is well managed.
Survival rates are general statistics based on people who received a diagnosis at least 5 years ago. Because there are so many variables, your outlook may be quite different. That's why it's best to discuss your outlook with your doctor.
PDX Engraftment Predicts High Recurrence And Poor Survival In Triple-negative Breast Cancer
Patient-derived xenografts (PDX) may accurately predict early recurrence and survival outcomes in triple negative breast cancer (TNBC), offering a potential tool for tailoring treatment strategies to reduce relapse risk.
Study: TOWARDS Study: Patient-Derived Xenograft Engraftment Predicts Poor Survival in Patients With Newly Diagnosed Triple-Negative Breast Cancer. Image Credit: Design_Cells / Shutterstock.Com
A recent study published in JCO Precision Oncology examines the association between patient-derived xenograft (PDX) with recurrence and survival rates in triple negative breast cancer (TNBC) patients.
Strategies to reduce TNBC recurrence riskCurrently, recurrence risk in TNBC is predicted by failure to obtain a pathologic complete response (pCR) to preoperative chemotherapy. Thus, pCR is used to obtain a long-term prognosis and monitor the effectiveness of preoperative treatment.
However, pCR fails to correlate well with relapse-free survival or overall survival (OS). The use of adjuvant chemotherapy to reduce recurrence risk has also produced mixed results in previous trials.
The inability to accurately identify patients at high risk of recurrence has led to the potential overtreatment of patients with early-stage TNBC with more toxic chemotherapy regimens. As a result, this intensive approach increases the risk of drug adverse effects without improving patient prognoses.
About the studyPDX looks and behaves like the tumor of origin, thus making it easier to predict how new drugs may act on the patient with this type of tumor. Although PDX engravement often correlates with a more aggressive phenotype, the rate of engraftment can be unpredictable and changes with tumor subtype.
The current study was a blinded trial on 80 patients with newly diagnosed TNBC, as well as tumors with low hormone receptors and negative human epidermal growth factor receptor-2 status. No intervention was provided to the patients during the trial. Tumors from these patients were removed and subsequently engrafted operatively into young female mice with severe combined immunodeficiency (SCID).
The aim of the current study was to establish more reliable risk markers for determining recurrence and breast cancer-related mortality risk based on the rate of successful engraftment of PDX from nonmetastatic TNBC.
The primary endpoint of the trial is three-year disease-free survival, with follow-up still ongoing. Thus, the current study reports disease-free OS at one year and pathologic response to neoadjuvant chemotherapy.
Engraftment and recurrence ratesThe median follow-up for the current study was 2.6 years. Overall, relapse occurred in 16% of patients, nine within one year of follow-up. Ten deaths were reported, nine of which were due to metastatic recurrent breast cancer. Eight of these nine patients were PDX-engraftment-positive.
Among 18 patients who were positive for PDX engraftment, eight had a year-one relapse for a relapse rate of 44.4%.
Even after definitive surgery, eight of 17 patients with successful engraftment relapsed within a year. Conversely, only one of 45 non-engraftment patients relapsed.
TNBC recurred within one year of definitive surgery in 80% of PDX-engraftment patients. The median survival in these patients was 0.55 years from the diagnosis of recurrence, whereas the postoperative relapse risk was 21.1 times higher in the engraftment group.
One relapse was reported among 62 non-engraftment patients for a relapse rate of 1.6%. Thus, the overall risk of relapse in the engraftment group was 17.5 times higher than in the non-engraftment group.
Conversely, three non-engraftment patients relapsed and none died within the period of follow-up to date. The median OS and breast cancer-specific survival (BCSS) were both 1.8 years in the engraftment group with hazard ratios of 21.1 and 39.5, respectively.
The pCR was not significantly associated with one-year relapse rates. Three patients achieved pCR but relapsed within the first year, all three of whom had successful PDX engraftment. All three patients died due to metastatic breast cancer within one year of biopsy-diagnosed relapse.
ConclusionsThe study findings indicate the potential of PDX engraftment to clearly, strongly, and independently predict early tumor recurrence in nonmetastatic TNBC. Successful engraftment reflects the aggressive behavior of the tumor cells, thereby revealing which tumors are likely to recur and metastasize with an exceptionally poor prognosis.
These patients could be given additional treatment to reduce recurrence rates, while simultaneously limiting unnecessary chemotherapy treatment for individuals at a low risk of recurrence. Moreover, high-risk patients could be administered therapies that act more effectively in relapse-prone cases to eliminate the disease altogether.
Although the current study is ongoing, these findings do not reveal correlations between engraftment and outcomes in patients with hormone receptor-positive tumors.
PDX engraftment is not a feasible clinical method. Thus, future research could focus on identifying biomarkers of engraftment to provide a clinically useful and viable surrogate for PDX engraftment in TNBC patients.
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