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First Patient Dosed In Study Assessing Immunotherapy In Metastatic Breast Cancer

The phase 1/2 study will assess next-generation immunotherapy alone and in combination with an immune checkpoint inhibitor in metastatic breast cancer.

The first patient in a phase 1/2 trial for metastatic breast cancer was dosed with a novel next-generation immunotherapy.

The first patient was dosed in a phase 1/2 study assessing the safety and efficacy of next-generation immunotherapy to treat patients with metastatic breast cancer whose disease did not respond to at least two systemic therapies.

A press release from BriaCell Therapeutics, the manufacturer of Bria-OTS, the personalized next-generation immunotherapy, noted that Bria-OTS will be investigated alone and in combination with the immune checkpoint inhibitor Tevimbra (tislelizumab).

"Dosing the first patient with Bria-OTS is a significant milestone for both BriaCell and cancer patients," Dr. Giuseppe Del Priore, Chief Medical Officer of BriaCell, said in the release. "This represents a new chapter in cancer immunotherapy. This groundbreaking technology is a major advancement over prior approaches to cellular immunotherapy."

Glossary

Immunotherapy: a therapy that uses materials to suppress or stimulate the immune system to help the body fight cancer

Immune checkpoint inhibitor: a drug that blocks certain proteins that are made by some types of immune system cells and some cancer cells. By blocking these proteins, this may lead to an improved approach to killing cancer cells

Overall response rate: the percentage of patients who have a partial or complete response to treatment

Progression-free survival: the time during and after treatment when a patient with cancer lives with the disease without worsening

Overall survival: the time when a patient with cancer is still alive

In this phase 1/2 trial, researchers are enrolling patients with metastatic or locally recurrent breast cancer previously treated with at least two systemic therapies such as chemotherapy and whose disease did not respond to those treatments, according to the release. Patients will be treated with Bria-OTS as monotherapy, then in combination with Tevimbra.

There are several measures of interest in this study, including safety, overall response rate, progression-free survival and overall survival.

"Designed for superior efficacy and synergy with immune checkpoint inhibitors, Bria-OTS is a personalized and off-the-shelf cancer therapy," Dr. William V. Williams, President and CEO of BriaCell, said in the release.

BriaCell-OTC, according to the pharmaceutical company's website, is a personalized off-the-shelf immunotherapy that is engineered to express 15 types of human leukocyte antigens (HLAs). The National Cancer Institute noted that HLA is a type of molecule found on the surface of most cells and plays a part in the body's immune response to foreign substances. Of note, HLAs can vary from person to person.

"Oncologists have been looking for treatments for our metastatic cancer patients who progress after treatment with antibody-drug conjugates and immune checkpoint inhibitors," Dr. Sant P. Chawla, Head of the Sarcoma Oncology Center in Santa Monica, California, and principal investigator for the study, said in the release. "We are very impressed by the survival and clinical benefit data we have seen with Bria-IMT and are looking forward to helping develop this novel platform with the goal of improving patient outcomes."

According to BriaCell's website, Bria-IMT is an off-the-shelf targeted cell-based immunotherapy for the treatment of patients with metastatic breast cancer. In particular, it is a genetically engineered human breast cancer cell line that includes immune cells.

Bria-IMT was granted fast-track designation by the Food and Drug Administration in 2022, meaning that the agency agreed to increase communication with the drug's manufacturer to potentially approve the therapy earlier than originally anticipated.

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Underwear Model Has Double Mastectomy After Her Sister Gets Cancer

The 30-year-old discovered she carried the cancer-linked 'PALB2' gene while pregnant (

Image: Jade Power© SWNS)

An underwear model opted for a voluntary double mastectomy after discovering she had a heightened risk of breast cancer. Jade Power is now back in the modelling world following reconstructive surgery - and claims she feels sexier than ever.

The 30-year-old discovered she carried the cancer-linked 'PALB2' gene while pregnant, upping her risk of breast cancer to a worrying 71%. So, after a nine-month wait to breast feed her child, she underwent a risk-reducing surgery, and now feels 'blessed'.

"When I made the decision to have the surgery I couldn't find anyone who was positive about it- I want to be that positive voice for others," she said. "I worried that I might never be able to wear beautiful bras again, but I feel genuinely blessed.

Jade Power is now back in the modelling world following reconstructive surgery (

Image:

Mark Barnfield© SWNS)

"Having the double mastectomy was a 100% certain decision for me, but I worried I might feel less feminine - I can safely say now that I feel 100% a woman still." Jade learned about her cancer risk after her sister, Donna Power, now 41, was diagnosed with breast cancer in 2021 when Jade was 27.

A test revealed that both women carry the Brca-related gene PALB2. While PALB2 typically helps prevent cancer, when it mutates, it no longer functions correctly, increasing the risk of breast cancer for those with the mutation.

The operation took place at Guys Hospital in London on August 12, when Jade was 28. She underwent reconstructive surgery and now has 34D size implants, and managed to keep her own nipples.

Together with her sister, Jade has launched a campaign named Not Just Braca (

Image:

Adon Blackwood© SWNS)

Find out about the symptoms you need to watch out for and get health advice with our free health newsletter from the Mirror

Together with her sister, Jade has launched a campaign named Not Just Braca to raise awareness about the hereditary causes of breast and other cancers. Jade, from Rye, Sussex, said: "I just couldn't live with that level of risk. Once you've been diagnosed it affects your fertility and everything.

"If someone told you there was a 71% chance the brakes on your car would fail then you wouldn't go out in it. My sister had already been diagnosed and was too ill from chemo to make the choice I was able to make.

"It feels amazing to be back doing lingerie modelling and feeling confident. I can't think of a better way to celebrate than modelling my favourite brand - Bravissimo. It's been a long journey but I feel more empowered now than ever."

What is a mastectomy and when is it recommended?

The NHS website says a mastectomy is an operation carried out to remove a breast. It's used to treat breast cancer in women and breast cancer in men.

The procedure takes about 90 minutes. Most people return home the next day.

The NHS says it can take four to six weeks to recover. A mastectomy may be recommended if:

cancer has spread throughout the breast

the breast is full of pre-cancerous cells

cancer is in a large area of the breast

Some women at high risk of breast cancer elect to have a mastectomy even when there is no sign of cancer.

Breast reconstruction after a mastectomy

A surgeon will usually talk to a mastectomy patient about the possibility of breast reconstruction. This is an operation to make a replacement for the tissue removed during a mastectomy.

It is often done at the same time as a mastectomy. However, it can be done at a later date.

Some people decide not to have breast reconstruction. You can find out more about breast reconstruction surgery after a mastectomy on the Cancer Research UK website.

Black Women Face Higher Breast Cancer Mortality Rates Across All Subtypes, Study Reveals

A new study found that Black women are more likely to die from breast cancer than white women across all subtypes of the disease.

Previous research has established the higher mortality rate for Black women, but the new study points to systemic disparities, not a difference in breast cancer type, to explain the gap.

Experts say it's up to healthcare systems to address barriers to treatment and better track patients to ensure no one is left behind.

Even though Black and white women are diagnosed with breast cancer at similar rates, Black women are around 40% more likely to die from the disease. Now, a new study has found that this is true across all types of breast cancer. 

According to the research, published in September in the Journal of Clinical Oncology, this outcome is at least partially due to factors other than biology, including socioeconomic inequality, delays in diagnosis, and systemic racism.

"Black women are more likely to die of breast cancer no matter the subtype," Jasmine Miller-Kleinhenz, PhD, assistant professor of population health at the University of Mississippi Medical Center, told Health. "This is important because it highlights that these health disparities are not just a matter of tumor biology, but are determined by social and structural drivers of health."

Here's what experts had to say about the new study and how the U.S. Can address breast cancer disparities between Black and white women.

The fact that Black women die from breast cancer at higher rates than white women is well-established. However, not all cases of breast cancer are the same. The aim of the new research was to determine whether disparities in mortality rate exist across all subtypes of breast cancer. There are multiple types of breast cancer, and all of them have different risk factors, treatments, and prognosis. These subtypes are based on different hormones, as well as a protein called human epidermal growth receptor 2 (HER2). When a tumor doesn't have progesterone or estrogen receptors and doesn't make much HER2 protein, it's considered "triple-negative." This is the most aggressive type of breast cancer and has few treatment options. Meanwhile, tumors that express estrogen and/or progesterone (called hormone receptor-positive) have a better prognosis. If cancer cells make more HER2 protein, they're called HER2-positive—these tumors spread more quickly but also better respond to treatment as compared to HER2-negative tumors. And there are documented racial differences among these subtypes. As compared to white women, Black women have a higher incidence of triple-negative tumors and a lower incidence of easier-to-treat hormone receptor-positive/HER2-negative tumors. The higher prevalence of aggressive breast cancer tumors in Black women contributes to the racial disparity in mortality, but it doesn't fully explain it, the new research found. For the study, the researchers analyzed 18 studies published between 2009 and 2022 that included 34,262 Black patients and 182,466 White patients with stage I to IV breast cancer. They found that, as compared to white women, Black women had a 50% higher risk of death from hormone receptor-positive/HER2-negative tumors and a 34% higher mortality risk from hormone receptor-positive positive/HER2-positive tumors. For the more dangerous hormone receptor-negative tumors, Black women had a 20% and 17% higher mortality rate from HER2-positive and HER2-negative tumors, respectively. Essentially, "Black women are dying at a higher rate of breast cancer, whether the tumor is considered prognostically favorable or not," Miller-Kleinhenz explained. These results suggest that there is something beyond biology driving these disparities, said Erica Warner, ScD, MPH, a cancer epidemiologist at Massachusetts General Hospital and senior author of the study. "There was some thought that the higher prevalence of triple-negative tumors in Black women was a significant contributor to disparities," Warner told Health. "Tumor subtypes matter, but can't explain the differences in survival because, among Black and white women with the same tumor subtype, we still found that Black women were more likely to die." Hormone receptor-positive tumors are easier to detect with mammography and have more treatment options, Warner explained. However, this also presents "more opportunity for gaps in care," she said, which could explain the greater racial morality disparities seen in the study results. Despite the study's large sample size, there are a few limitations. For one, the study had relatively low numbers of people in some of the subtype analyses, Warner said, which could've impacted precision. Also, because the researchers didn't have individual data for all of the study participants, they weren't able to determine how factors such as treatment or experiences of racism could've affected the results, she added. Previous research has shown that Black women tend to be diagnosed with breast cancer at a younger age than White women. Plus, while breast cancer rates have remained stable among white women, they have increased by 0.4% per year among Black women since 1975. And these disparities aren't unique to Black women. American Indian/Alaska Native (AIAN) women have higher breast cancer mortality rates than white women, despite lower incidence. And Black, Hispanic, and AIAN women are less likely to be diagnosed with localized-stage breast cancer (meaning it's easier to treat) as compared to Asian/Pacific Islander and white women. So why is this the case? "Access to care, socioeconomic barriers, and cultural challenges in navigating the healthcare system all contribute to these disparities," Corey Speers, MD, PhD, a radiation oncologist and co-director of the breast cancer program at the University Hospitals Cleveland Medical Center, told Health. "Though the exact drivers may differ across groups, the common theme is a lack of equitable access to early diagnosis and cutting-edge treatment." This can manifest in a number of ways. For one, "Black women may face greater health insurance inequities than other populations," Tingting Tan, MD, PhD, a medical oncologist and hematologist at City of Hope Newport Beach, told Health. Women of color may also have less access to high-quality healthcare institutions, making it harder for them to receive mammography or other preventative screening, as well as quality treatment after they're diagnosed, Speer and Tan explained. For example, lower-income patients may have a harder time arranging childcare, taking time off of work, and getting transportation to a treatment facility, said Tan. Plus, Speer added, mistrust of medical institutions may also decrease the likelihood that Black women get high-quality treatment or follow-up care once they've been diagnosed with breast cancer. These social determinants of health are coupled with genetic or biological factors that drive disparities in cancer mortality, too. Black women are twice as likely to develop triple-negative breast cancer as compared to white women and are also more likely to have other conditions that increase breast cancer risk, including diabetes, obesity, and heart disease, Tan said. "It's not just biology—at times, it is the system itself is contributing to the disparities in mortality," Speer said. To ultimately close these gaps in breast cancer mortality, experts say there are a number of systemic changes that need to happen. "This includes improving access to timely, high-quality care, and ensuring that all women—regardless of race or socioeconomic status—have access to the same advanced treatments and clinical trials," Speers said. Data consistently show that Black women have mammography screening rates that are the same or better than white women in the U.S., Warner pointed out. So, she said, "this suggests that to improve early detection, we need to make sure that women with abnormal findings receive timely diagnostic care and treatment." To that end, healthcare systems should track their breast cancer patients, and use demographic factors to identify any gaps or treatment steps where some people are being left behind, Warner said. There's also a need for more studies that can investigate how various structural, social, and environmental drivers of health are impacting communities, Miller-Kleinhenz said. "This will require developing cohorts that have more Black women represented and that have data that will allow us to study these important questions so that we can close this gap and achieve the ultimate goal of health equity," she said. Healthcare practitioners also play a role. "As breast radiologists, we have to do our due diligence in raising awareness about healthcare disparities that affect the lives of our patients," Georgia Spear, MD, division chief of breast imaging at Endeavor Health, told Health. "We also need to take action to ensure equitable access to health care so all women have the lifesaving care they need."

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