Latest news with #Perjeta
Yahoo
02-06-2025
- Business
- Yahoo
Enhertu potential broadens as new data point to frontline breast cancer role
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. CHICAGO — Enhertu, the antibody-drug conjugate developed by AstraZeneca and Daiichi Sankyo, year by year proves more indispensable in the treatment of metastatic breast cancer. Already enmeshed in clinical practice as a go-to choice for tumors that have come back once, Enhertu could soon have a role to play in initial treatment as well. On Monday, researchers shared results from a large trial showing Enhertu together with an older drug called Perjeta offer greater benefit in certain tumors than the current first-line standard, which includes Perjeta, the stalwart breast cancer drug Herceptin and chemotherapy. The data will be presented Monday morning at the American Society of Clinical Oncology's annual meeting held here. Known as Destiny-Breast09, the Phase 3 trial focused on people whose breast tumors were either locally advanced or had metastasized, and tested positive for a protein, HER2, that typically signals faster-spreading cancer. About 15% to 20% of breast cancers are HER2-positive and for decades now have been treated by Herceptin, Perjeta and other treatments that home in on the protein. Enhertu is one of the newest — and most powerful — iterations. It consists of a HER2-targeting antibody linked to a tumor-killing toxin. Since winning its first U.S. approval in 2019, the drug has marched upwards through breast cancer treatment lines and into new uses in lung and stomach cancers. Last year, sales reached $3.7 billion. Sales could rise further should findings from Destiny-Breast09 support frontline use in HER2-positive metastatic disease. In the trial, treatment with Enhertu and Perjeta delayed cancer growth for longer than the established regimen of Perjeta, Herceptin and chemotherapy, which is known by the acronym THP. Progression-free survival, which measures time from treatment to disease progression or death, reached a median of nearly 41 months among the 383 patients who received Enhertu and Perjeta, versus 27 months among the 387 given THP. 'That's a phenomenal advantage in progression-free survival and it's definitely practice-changing,' said Vishwanath Sathyanarayanan, a medical oncologist and an academic advisor at Apollo Hospitals in Bangalore, India. Eleonora Teplinsky, head of breast and gynecologic medical oncology at New Jersey's Valley-Mount Sinai Comprehensive Cancer Care, agreed, although she cautioned that Enhertu comes with its own safety risks. 'While keeping an eye on [Enhertu's] toxicity, it's really hard to ignore that data.' About 15% of patients given Enhertu plus Perjeta had a complete response following treatment — meaning no detectable signs of cancer — versus 8.5% among those on THP. Researchers could not yet statistically determine whether the Enhertu regimen offered a benefit in survival, but reported that data are trending in that direction. Patients will continue to be monitored for further analysis later. AstraZeneca and Daiichi Sankyo, which announced Destiny-Breast09 succeeded in late April, have said they plan to share the trial data with regulators. But they haven't clarified when they might seek an approval of Enhertu as part of first-line treatment. Should it win an OK, doctors will have to grapple with a number of trade-offs and unanswered questions, not least of which are Enhertu's side effects. The drug's current labeling carries a 'black box' warning for interstitial lung disease and pneumonitis, which can be life-threatening. In Destiny-Breast09, this side effect occurred in 46 patients treated with Enhertu and Perjeta, compared to only 4 who received THP. While most cases were mild, two of the Enhertu-treated patients died. Most participants in the trial were under 65 years old. As a result, Teplinsky said, it is not clear how well older patients might fare with Enhertu and Perjeta in the first-line setting. Results from another study presented at ASCO suggest that, in mild cases of interstitial lung disease, Enhertu can be reintroduced after the side effect has been brought under control. Moving Enhertu earlier in treatment also raises questions about how long it should be given and, if patients' disease progresses, what should be administered afterwards. 'Is this for all patients at the beginning of treatment? We don't know,' said Rebecca Dent, the deputy clinical chief executive officer at National Cancer Center Singapore, in a press conference with reporters. 'Is there a way to sequence this induction therapy that includes [Enhertu] followed by a maintenance stage of treatment?' Destiny-Breast09 is also evaluating a third group of 387 patients who were given only Enhertu and a placebo. Researchers didn't yet have sufficient data to compare that arm to the other two when they conducted their initial, interim analysis. Evidence supporting Enhertu monotherapy over THP would be significant if it materializes, said Sathyanarayanan, who noted that giving multiple, expensive drugs in combination can be challenging in low- and middle-income countries. AstraZeneca and Daiichi Sankyo are studying Enhertu in even earlier settings, testing whether it could be given before or after surgery to remove a tumor. Last month, the companies said a study called Destiny-Breast11 succeeded, finding Enhertu followed by THP improved complete response rates versus standard of care when used before surgery. And in stomach cancer, study data presented at ASCO on Saturday could help cement Enhertu's place as a second-line treatment option for gastric tumors. Recommended Reading At ASCO, Enhertu cements growing role in stomach cancer care
Yahoo
15-05-2025
- Health
- Yahoo
Roche reports final overall survival outcomes from breast cancer treatment trial
Swiss pharmaceutical company Roche has reported final overall survival outcomes from a long-term Phase III trial of Perjeta (pertuzumab) with Herceptin (trastuzumab) and chemotherapy for treating breast cancer. The randomised APHINITY trial assessed the combination's efficacy and safety against those of Herceptin and chemotherapy in 4,804 subjects with human epidermal growth factor receptor 2 (HER2) positive early-stage breast cancer. Its primary goal was to measure invasive disease-free survival, which the study defines as the time a patient lives with no recurrence of invasive breast cancer or mortality from any cause after the surgery, over ten years. Results from the study showed a 17% decrease in the mortality risk for the Perjeta-based regimen-treated subjects versus those who received Herceptin, chemotherapy and placebo. Of the subjects given Perjeta, 91.6% were still alive after ten years, compared with 89.8% in the other group. The company also reported a 21% decrease in mortality risk in subjects with lymph node-positive disease. Perjeta's safety profile, including cardiac safety, was found to be consistent with prior studies, without any new safety concerns observed. In addition, the drug's previously reported invasive disease-free survival benefit was maintained with a hazard ratio of 0.79, complementing outcomes from previous APHINITY analyses, without any benefits observed in the node-negative subgroup. Roche global product development head and chief medical officer Levi Garraway said: 'Early treatment of breast cancer can provide substantial patient benefit and also increases the chance for cure. 'For people with early-stage HER2-positive disease, the APHINITY results validate the sustained benefits of the Perjeta-based regimen.' Roche said that its work with BIG and other trial partners had enabled studies such as HERA and APHINITY, which have reportedly led to Perjeta and Herceptin becoming standard-of-care treatments. The Perjeta-based regimen has so far received approval in more than 120 countries for treating early-stage and metastatic HER2-positive breast cancer. "Roche reports final overall survival outcomes from breast cancer treatment trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 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
Malay Mail
30-04-2025
- Health
- Malay Mail
Cancer Diaries: The horrors persist and I will file a complaint
APRIL 30 — When my grandfather was dying, he climbed a ladder and fell off it. He passed on not long after. It wasn't from the fall however, it was mostly from complications of late-diagnosed brain cancer. I wonder what he would have thought if he could see me last week, also up a ladder. My ceiling light needed replacing and it was a task I often did myself. As I perched, seated on top of my faithful, paint-splashed aluminium ladder, reaching my arm out, I realised this time it was beyond me. My arm could not stay steady enough to properly fit the new light into the brackets. I kept taking deep breaths, raising my arm again, and again, until I accepted it was a lost cause. It feels as though cancer's job is to keep knocking me down multiple pegs until I accept that I am but a limp noodle wrapped in skin, fragile and weakened. Last week was rough as not only was my roof leaking, my air conditioner suddenly decided to release a stream of liquid on my bedroom floor, my legs were stiff and prone to giving way and everything tasted like s**t. I gave into my inner child's desire to run away and made camp at a nearby hotel — thank goodness for last-minute booking discount rates. A good night's sleep helped me see there were some bright sides to my situation. Fixing my roof and air conditioning now would mean they wouldn't be vexing me during my convalescence period post-surgery. As of writing, my roof has been re-waterproofed, my air conditioner serviced, but now it seems the plumber must visit to check on my gutters (no this is not the setup for a porn episode). I am counting down the days to my surgery mid-May and it feels like the days are coming faster and faster while the weeds in my garden threaten to engulf the house. It is vexing coming to terms with my current fragility while knowing that I will be even more made of glass post-surgery. Perhaps climbing a ladder was a way for me to feel less like a very crabby piece of crystal. At least, for now, my bones have stopped hurting though one of my toenails is turning black and odd smells, like a certain fast food chain's mango egg tart (a culinary abomination) make my stomach turn. Thanks for ladders that stay strong, even when legs sometimes don't. — Unsplash pic I am restless, and perhaps more than a little reckless, but if you were me, perhaps you too would be fiddling with the lights out of boredom and needing a change of scenery. Alas, I can't (by choice) travel beyond the Klang Valley as I can't risk coming down with something so close to my long-awaited lumpectomy. I hope that it will be just the one surgery, that my surgeon gets clean margins, because otherwise I will need to again be wheeled into the operating theatre until a satisfactory amount of cancer cells have been excised. There is no point in mulling the what-ifs for now as I have an echocardiogram next week and another immunotherapy session, where I will have one final round of the very expensive Perjeta drug. Then I will just be bleeding money paying for Herceptin (which is nearly RM2,000 per infusion) every three weeks for as long as my doctors think I need it. Meanwhile I hear there is a shortage of the cancer drug letrozole at Universiti Malaya Medical Centre, which must be vexing. I wonder if I will have to worry about my medication supply once I finish my immunotherapy and radiotherapy sessions, and start on five years or so of medications such as tamoxifen. Still, I will just have to do what I've been doing — crossing each bridge, and river, as they come while trying to remain sane. It does no good for me to worry about hypothetical situations such as my cancer fund running out or my cancer cells being more stubborn than expected. For now I am alive despite my strange affectation for climbing up ladders despite my fear of heights so I will still enjoy being able to breathe, move, eat and tell you all about what daft thing I did this week, every week. I will give thanks for ladders that stay strong, even when my legs don't, and my guardian angel who is probably overworked and contemplating retirement. Until next week, dear reader, when we find out if my heart has survived all the drugs I've made it endure so far. * This is the personal opinion of the columnist.
Wales Online
22-04-2025
- Health
- Wales Online
'I thought symptoms were just being a mum so cancer spread for three years'
'I thought symptoms were just being a mum so cancer spread for three years' Doctors told Kate she had sciatica and she wasn't offered an x-ray Kate Crawford initially blamed her tiredness and other minor symptoms on her busy life as a mother of three very young children (Image: Cover Images ) A young mum who was told she was suffering from sciatica by doctors was later diagnosed with stage 4 breast cancer. Kate Crawford initially blamed her tiredness and other minor symptoms on her busy life as a mother of three very young children. By the time she was diagnosed the disease had been silently spreading through her body for two to three years, leaving her no choice but to have radical treatment. 'If the doctor had just done an x-ray, he would've seen I had cancer,' she says. 'One day, I was a 28-year-old mum of babies, and the next, I was being told I might not be here much longer. I didn't know what to look for. I just thought I was tired because I was a new mum. But it wasn't just exhaustion - I was feeling excessively tired all the time, I had constant belly issues, a nagging cough that wouldn't go away, and pain in my bones that never seemed to improve. 'There were changes in my breasts that I didn't recognise as warning signs, bruises that didn't go away, and skin issues that I brushed off. I honestly thought I was just rundown. If I had been more educated in the signs, I might have been able to better advocate for myself. It may be too late for me, but it's not for you. If something doesn't feel right, please don't ignore it.' She immediately started aggressive treatment; harsh chemotherapy, targeted therapies like Herceptin and Perjeta, and a shot of Xgeva to help with bone metastases. Now 41, Kate has had 200 plus treatments including a double mastectomy and spent nearly a third of her life in a relentless battle for survival. Her husband Steve has been constantly at her side along with their children, twins Grace and Lily, now 16, and Stephen, 15. She says Steve is her anchor. At times her treatment has been far from straightforward. She has had allergic reactions, heart failure and even developed early-stage lung disease. Article continues below Kate and her children 'Whenever my heart isn't doing well, I have to stop Herceptin and then the cancer starts growing again,' she explains. 'It's just this really crazy cycle.' Kate has kept fighting, adapting her life around the three week treatment cycle and her changing body. 'A stage 4 diagnosis means treatment for life and side effects for life,' she says. 'When one thing pops up, you just have to deal with it. Take it one step at a time. That time lets me relax and unwind. It reminds me to look for the glimmers.' She concentrates on small joys - from floating in a lake on a calm day, laughing with her kids, or discovering a new jumper that fits just right. 'I just want to keep making memories with my family. That's all I've ever wanted,' she says. She shares her life on TikTok with humour and brutal honesty about the challenges cancer patients face every day. One video shows her trying on swimwear post-mastectomy and struggling to find any that fit just right. 'I've never tried to sugarcoat my life, but people forget the daily struggles,' she says. 'We hide a lot, not for ourselves but to make others feel better.' She warns against toxic positivity. 'It's ok to feel not ok. You don't always have to be the brave, stoic cancer patient,' she says. 'You can be mad, bitter, sad and still be full of love. That is perfectly ok. Kate Crawford 'Getting diagnosed with cancer is like jumping into a big metaphorical lake full of other cancer patients. We're all in there together, but we can't help each other. We carefully tread water, but we get tired. Sometimes we barely hang on. People cheer from the shore. Some get rescued. Others stay. Some never make it out.' Article continues below Kate works as a social media manager and family support specialist at One Day to Remember, a nonprofit close to her heart. 'They provide solace and unforgettable experiences to families affected by cancer. The emotional trauma these families go through is staggering,' she says. 'But One Day to Remember makes sure they get to experience joy - even in the most challenging times.' And despite a terminal diagnosis, Kate is still full of life. Her message is clear: You are never too young to get cancer. And sometimes, what feels like exhaustion or a stubborn cough can be something more serious. 'I didn't know the signs,' she says. 'That's what I want people to take away from this. Know your body. Don't ignore your gut. It might just save your life.'
Yahoo
16-04-2025
- Health
- Yahoo
Cancer Diaries: The treatment worked but now comes surgery
APRIL 16 — You don't look like a cancer patient, my friend said. I don't blame him — the people he's known to have cancer were noticeably gaunt, shedding weight quickly to the point they seemed to be wasting away. Meanwhile, I just found out I gained 2 kilogrammes since my last weigh-in three weeks ago. It annoys me greatly. If it wasn't for my bald head (and my telling everyone), I think people wouldn't even realise I had cancer. There are more things that people don't see. I am a bit tired of being told I am strong, a warrior, so positive when the simple reason that I seem almost unruffled by all this is because trauma and pain are no strangers to me. When you've faced many trials or had what Chinese soothsayers would call 命硬 (rough life) every tribulation just feels like one more thing to get over and I am, albeit unwillingly, forged in fire. Of course I have negative feelings and thoughts about this whole cancer thing, and I am not special in any way. I'm just pragmatic. After getting my tears, rage and nervous breakdown over with, I have no choice but to focus on getting every cancer treatment hurdle over with and I am happy to announce that while you're reading this I will be undergoing my final (hopefully) chemo treatment. Even more good news — physical examination found no palpable proof of a tumour so now comes surgery, scheduled next month. This was made possible thanks to being able to pay for my Perjeta infusions in the first place. I got done with an X-ray but will need to see an anesthesiologist, have another echocardiogram, one more round of immunotherapy and then a pre-surgery medical appointment. — Unsplash pic The surgery will remove what is left of my tumour as well as any cancerous lymph nodes and between now and then, I have even more appointments. I got done with an X-ray but will need to see an anesthesiologist, have another echocardiogram, one more round of immunotherapy (Perjeta and Herceptin) and then a pre-surgery medical appointment. Yes, I am very tired of going to the hospital multiple times a month but that's just the cancer life for you. After getting the good news about my cancer tumour status and surgery date, I was texting multiple people and also making different posts on my social media. It might seem like tedium but isn't that a good 'problem' to have? To have more than one person happy to hear from you about your cancer updates and having people to share in your joy is, I found out, not always a reality for many people. In the time since my diagnosis I've heard news of cancer deaths, not people I knew personally but dear friends of friends or in the case of another friend, a parent. While I'm happy to reach one cancer milestone I will always be reminded that some cancer journeys are sadder or rockier, while some end far too soon or begin too late. I know that right now I am where I am because of my circumstances and the support from friends and strangers. What I've also learned is that we need more doctors, better facilities, a means of funding care and better preventative healthcare besides telling Malaysians they eat too much and they're too fat. Again I remind you, if you're reading this, to not delay addressing any doubts of fears about the state of your health. If you're scared of the cost, look around and ask — if not public healthcare, Socso's Behati exists and many NGOs advocating for specific diseases often have drives to promote testing. For now, dear reader, I wish you the best of luck and the best of health.
