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Sacituzumab or Chemo in First-Line TNBC: Which Is Better?
Sacituzumab or Chemo in First-Line TNBC: Which Is Better?

Medscape

time2 days ago

  • Health
  • Medscape

Sacituzumab or Chemo in First-Line TNBC: Which Is Better?

Treatment with pembrolizumab and the antibody-drug conjugate (ADC) sacituzumab govitecan improved progression-free survival (PFS) in patients with PD-L1-positive locally advanced or metastatic triple-negative breast cancer (TNBC) compared with treatment with pembrolizumab and chemotherapy, the results of ASCENT-04/KEYNOTE-D19 showed. Swapping in sacituzumab govitecan for chemotherapy led to a 3.4-month improvement in PFS and an almost twofold longer duration of response, with potentially fewer adverse events and a lower rate of discontinuations. Currently, pembrolizumab with chemotherapy is the standard of care for PD-L1-positive TNBC, but the 3-year survival rate remains low at about 36%. These findings support sacituzumab govitecan and pembrolizumab as the new standard for previously untreated patients in this setting, said lead investigator Sara Tolaney, MD, MPH, who presented the results at the American Society of Clinical Oncology (ASCO) 2025 annual meeting. Once the new combination with sacituzumab govitecan, which targets the Trop-2 protein on tumor cells, is approved, 'I would recommend it in the first-line setting,' said Tolaney, a breast medical oncologist at the Dana-Farber Cancer Institute, Boston, Massachusetts. 'I think this really does change the game for' PD-L1-positive metastatic TNBC, said study discussant Jane Meisel, MD, a breast medical oncologist at Emory University, Atlanta, Georgia. 'I look forward to seeing this potentially make its way into clinical practice.' The study included 443 women who had either de novo metastatic disease or were at least 6 months away from completing systemic therapy for early-stage disease. Patients had a combined positive PD-L1 score of 10 or higher, and about 40% of TNBC tumors expressed the Trop-2 protein. Half of the patients were randomly assigned to 10 mg/kg sacituzumab govitecan on day 1 and day 8, plus pembrolizumab 200 mg on day 1 of 21-day cycles for a maximum of 35 cycles (n = 221). The other half were randomly assigned to pembrolizumab on the same schedule plus investigators' choice of gemcitabine plus carboplatin or paclitaxel/nab-paclitaxel (n = 222). Approximately 5% of patients had received a prior checkpoint inhibitor for earlier-stage disease; 43% of women in the chemotherapy arm crossed over to sacituzumab govitecan monotherapy after progression. At a median follow-up of 14 months, median PFS was 11.2 months in the sacituzumab govitecan group vs 7.8 months in the chemotherapy group, which translated to a 35% lower risk of cancer progression during follow-up (hazard ratio [HR], 0.65; P = .0009). Tolaney noted that PFS in the ADC group increased with higher Trop-2 expression, but the ADC group also did better than the chemotherapy arm regardless of Trop-2 levels, suggesting that 'you didn't need to preselect patients for use of sacituzumab by Trop-2.' Median duration of response was 16.5 months with sacituzumab govitecan vs 9.2 months with chemotherapy. Although overall survival follow-up is ongoing, the trend favors the ADC group (HR, 0.89). Commenting on the study, Julie Gralow, MD, a breast medical oncologist at the University of Washington, Seattle, noted that sacituzumab govitecan is already indicated as monotherapy in the third or later lines for metastatic disease. The ASCENT-04 results 'will likely move this drug, this regimen, earlier in the metastatic setting' for TNBC, Gralow agreed. On the side effect front, the most common (≥10% of patients) grade 3 and 4 adverse events in the sacituzumab govitecan group were neutropenia (43%) and diarrhea (10%); in the chemotherapy group, the most common adverse events were neutropenia (45%), anemia (16%), and thrombocytopenia (14%). Serious adverse events were numerically more common in the ADC arm (38 vs 31), but there were fewer dose reductions and fewer treatment discontinuations than with chemotherapy. 'The nice thing is that many of us have used both of these agents, sacituzumab and pembrolizumab, quite a bit,' and with no new safety signals, breast oncologists will 'feel comfortable with [the combination] once it makes its way into the clinic,' Meisel said. The work was funded by Gilead Sciences, maker of sacituzumab govitecan. Tolaney disclosed research and travel funding from Gilead and is a Gilead advisor. Gralow and Meisel reported no relevant financial relationships.

Immune-boosting drug ‘could change the world' for cancer patients – warding off killer for years
Immune-boosting drug ‘could change the world' for cancer patients – warding off killer for years

The Sun

time3 days ago

  • Business
  • The Sun

Immune-boosting drug ‘could change the world' for cancer patients – warding off killer for years

AN immune boosting drug can stave off throat cancer for years longer than current treatments, a trial found. Recovering head and neck cancer patients treated with pembrolizumab, also known as Keytruda, remained cancer -free for an average of five years. That was twice as long as the 2.5 years for patients given regular chemotherapy. The risk of tumour cells spreading elsewhere in the body was also 10 per cent lower, the Institute for Cancer Research in London found. Pembrolizumab is an immunotherapy that is given before and after surgery. It works by boosting the body's own ability to seek and destroy cancer cells. Professor Kevin Harrington, trial leader author from the ICR and consultant oncologist at the Royal Marsden NHS Foundation Trust, said: 'For patients with newly-diagnosed, locally-advanced head and neck cancer, treatments haven't changed in over two decades. 'Immunotherapy has been amazingly beneficial for patients with cancer that has come back or spread around the body but, until now, it hasn't been as successful for those presenting for the first time with disease which has spread to nearby areas. 'This research shows that immunotherapy could change the world for these patients. 'It significantly decreases the chance of cancer spreading around the body, at which point it's incredibly difficult to treat. 'The results of this trial show that pembrolizumab dramatically increases the duration of disease remission – for years longer than the current standard treatments.' Head and neck cancer refers to a group of cancers that can develop anywhere in the head or neck, including the mouth, the oesophagus, the space behind the nose, the salivary gland, and the voice box. Standard care, which includes surgery to remove tumours followed by radiotherapy with or without chemotherapy, has not changed for these patients in more than 20 years, according to researchers. The global Keynote-689 trial was carried out at 192 sites in 24 countries, and involved 714 patients. Some 363 people received pembrolizumab followed by standard care, with the remainder receiving standard care only. Pembrolizumab works by targeting a protein known as PD-L1, which is found on T cells and helps the immune system recognise and fight cancer. By blocking this protein, the treatment helps the immune system fight cancer more effectively. The treatment is already approved for use on its own or in combination with chemotherapy for patients with a certain type of head and neck cancer that has come back or spread around the body. The trial, which is being presented at the American Society of Clinical Oncology (Asco) annual meeting, found cancer returned in half the patients given pembrolizumab after five years, compared with two-and-a-half years in those receiving standard care. After three years, the risk of cancer returning somewhere else in the body was also 10 per cent lower among those on pembrolizumab. 'It could change the world' 'It works particularly well for those with high levels of immune markers,' Prof Harrington said 'But it's really exciting to see that the treatment improves outcomes for all head and neck cancer patients, regardless of these levels.' Around 13,000 Brits develop head and neck cancers each year and 4,200 die from them. Many tumours are linked to smoking. Symptoms vary depending on the type of cancer but include: persistent ulcers, white or red patches, lumps, sores and pain. 2

Major breakthrough in cancer caused by oral sex - as cases continue to climb in under 50s
Major breakthrough in cancer caused by oral sex - as cases continue to climb in under 50s

Daily Mail​

time3 days ago

  • Business
  • Daily Mail​

Major breakthrough in cancer caused by oral sex - as cases continue to climb in under 50s

Thousands of patients with cancers of the head and neck have been thrown a lifeline by 'world changing' drug that dramatically slows the spread of the disease. The injection, called pembrolizumab, helps the immune system spot hidden cancer cells in the body. It is currently offered to NHS patients with advanced lung, breast and cervical cancers—but expert believe it hold far wider promise. Also known by the brand name Keytruda, a groundbreaking trial found the drug kept head and neck cancers at bay for five years compared to 30 months with standard treatments, including surgery, chemotherapy and radiotherapy. It also slashed the risk of the disease returning elsewhere in the body. Researchers presenting the findings at the American Society of Clinical Oncology conference in Chicago said the injection 'could change the world for these patients' offering them 'years longer than the current standard treatments'. Head and neck cancer is an umbrella term for cancers of the mouth, throat, voice box, nose, sinuses and salivary glands. Until recently, experts believed the main causes were lifestyle-related—particularly smoking and heavy drinking. In recent years, research has suggested that human papillomavirus (HPV) may be responsible for up to 70 per cent of head and neck cancers. HPV is a common virus spread through close contact, including sex, and is usually harmless. However, in some cases—for reasons not fully understood—it can trigger cancerous changes in healthy tissue. The virus is already known to cause cervical, anal and penile cancers. A rise in head and neck cancers, particularly among younger and middle-aged patients, has been linked to oral sex. In the global trial, carried out across 24 countries involving more than 700 head and neck cancer patients, 363 received pembrolizumab followed by standard treatment. The remainder had standard treatment only. Pembrolizumab is a checkpoint inhibitor—it works by helping the immune system recognise and fight cancer. Scientists found the cancer returned in half the patients given pembrolizumab after five years, compared with two-and-a-half years in those receiving standard care. After three years, the risk of cancer returning somewhere else in the body was also 10 per cent lower among those on pembrolizumab. Kevin Harrington, a professor of biological cancer therapies at the Institute of Cancer Research, London, and consultant oncologist at the Royal Marsden NHS Foundation Trust, said: 'For patients with newly-diagnosed, locally-advanced head and neck cancer, treatments haven't changed in over two decades. 'Immunotherapy has been amazingly beneficial for patients with cancer that has come back or spread around the body but, until now, it hasn't been as successful for those presenting for the first time with disease which has spread to nearby areas. 'This research shows that immunotherapy could change the world for these patients—it significantly decreases the chance of cancer spreading around the body, at which point it's incredibly difficult to treat.' Professor Harrington added that the drug 'dramatically increases the duration of disease remission—for years longer than the current standard treatments'. 'It works particularly well for those with high levels of immune markers, but it's really exciting to see that the treatment improves outcomes for all head and neck cancer patients, regardless of these levels,' he said. Laura Marston, 45, from Derbyshire was diagnosed with stage four tongue cancer in 2019 after an ulcer on her tongue didn't heal. She was later referred to The Royal Marsden where she joined the trial. 'I was so excited to be on a clinical trial and knowing I was in the best hands was really reassuring,' she said. 'As part of the trial I underwent two rounds of immunotherapy before undergoing surgery. 'In the months following my surgery I had to relearn how to eat and talk again while also having ten more infusions of immunotherapy, chemotherapy, and radiotherapy. 'My clinical team were amazing and went above and beyond for anything I needed. I am amazed I am still here six years later, this treatment has given me the gift of life.' Cancers that affect the head and neck are the eighth most common form of cancer overall in the UK, although they are two to three times more common in men than in women. About 12,500 new cases are diagnosed each year, according to Cancer Research UK, and incidences are on the rise. Dr Lyndsy Ambler, Cancer Research UK senior strategic evidence manager, said: 'Around 4,100 people die from head and neck cancers every year—that's approximately 11 deaths every day. 'Any potential new treatment options for a disease where there has been limited progress for decades are very welcome. 'Pembrolizumab's potential benefit for people with head and neck cancer could represent a significant step forward in how we treat the disease.'

Merus (MRUS) Price Target Raised at BMO After Positive Phase 2 Data
Merus (MRUS) Price Target Raised at BMO After Positive Phase 2 Data

Yahoo

time25-05-2025

  • Business
  • Yahoo

Merus (MRUS) Price Target Raised at BMO After Positive Phase 2 Data

BMO Capital Markets maintained its Outperform rating on Merus N.V. (NASDAQ:MRUS) shares on May 24 while raising its price target from $96 to $110. The revision comes after encouraging Phase 2 data for Merus' drug candidates petosemtamab and pembrolizumab (pembro) were released. The drugs are intended to treat recurrent or metastatic Head and neck squamous cell carcinoma (HNSCC). Presented at the American Society of Clinical Oncology (ASCO), Merus' updated data included findings from an analysis of 43 evaluable patients conducted on February 27, 2025. With a confirmed Objective Response Rate (ORR) of 63%, the study demonstrated robust and long-lasting responses. Notably, a 79% survival rate was shown by the 12-month Overall Survival data. The standard of care for pembrolizumab, which carries a reported survival rate of roughly 50–59%, compares favorably to this. The market's response to the ASCO presentation indicates that petosemtamab's clinical potential to take the HNSCC treatment landscape to new heights is well-supported. The price target increase and revised estimates also demonstrate growing investor confidence in the drug's prospects. Evan David Seigerman of BMO Capital backed this assessment after the approval probability rose from 85% to 90%, pointing to favorable safety data. While we acknowledge the potential of MRUS to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than MRUS and that has 100x upside potential, check out our report about the cheapest AI stock. Read More: and . Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Merus (MRUS) Price Target Raised at BMO After Positive Phase 2 Data
Merus (MRUS) Price Target Raised at BMO After Positive Phase 2 Data

Yahoo

time25-05-2025

  • Business
  • Yahoo

Merus (MRUS) Price Target Raised at BMO After Positive Phase 2 Data

BMO Capital Markets maintained its Outperform rating on Merus N.V. (NASDAQ:MRUS) shares on May 24 while raising its price target from $96 to $110. The revision comes after encouraging Phase 2 data for Merus' drug candidates petosemtamab and pembrolizumab (pembro) were released. The drugs are intended to treat recurrent or metastatic Head and neck squamous cell carcinoma (HNSCC). Presented at the American Society of Clinical Oncology (ASCO), Merus' updated data included findings from an analysis of 43 evaluable patients conducted on February 27, 2025. With a confirmed Objective Response Rate (ORR) of 63%, the study demonstrated robust and long-lasting responses. Notably, a 79% survival rate was shown by the 12-month Overall Survival data. The standard of care for pembrolizumab, which carries a reported survival rate of roughly 50–59%, compares favorably to this. The market's response to the ASCO presentation indicates that petosemtamab's clinical potential to take the HNSCC treatment landscape to new heights is well-supported. The price target increase and revised estimates also demonstrate growing investor confidence in the drug's prospects. Evan David Seigerman of BMO Capital backed this assessment after the approval probability rose from 85% to 90%, pointing to favorable safety data. While we acknowledge the potential of MRUS to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than MRUS and that has 100x upside potential, check out our report about the cheapest AI stock. Read More: and . Disclosure: None.

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