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National Post
18 minutes ago
- National Post
BeOne Medicines Receives Positive CHMP Opinion for TEVIMBRA® in Neoadjuvant/Adjuvant NSCLC Treatment
Article content Recommendation based on Phase 3 RATIONALE-315 study, in which TEVIMBRA demonstrated clinically meaningful and statistically significant improvement in event-free survival and major pathological response Article content If approved, the expanded label builds on TEVIMBRA's momentum in lung cancer with EU approvals already in NSCLC and SCLC indications across both first- and second-line settings Article content Article content SAN CARLOS, Calif. — BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of TEVIMBRA ® (tislelizumab), in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence. This recommendation is based on the Phase 3 RATIONALE-315 study ( NCT04379635). Article content 'Patients with resectable, early-stage NSCLC face an urgent challenge – despite surgery and current therapies, recurrence rates remain alarmingly high,' said Dr. Mariano Provencio, Head of the Medical Oncology Department at Hospital Universitario Puerta de Hierro and Professor at the Faculty of Medicine of Universidad Autonoma de Madrid in Spain. 'The significant clinical benefit observed in the RATIONALE-315 study has important implications for patients. If approved, perioperative tislelizumab will offer oncologists a powerful new option to improve outcomes and potentially alter the course of this difficult-to-treat disease.' Article content RATIONALE-315 is a double-blind, placebo-controlled, multicenter, Phase 3 study that randomized 453 patients with resectable NSCLC 1:1 to receive either TEVIMBRA plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by TEVIMBRA as adjuvant treatment or placebo plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by placebo as adjuvant treatment. As previously reported at the European Society for Medical Oncology (ESMO) Congress Virtual Plenary in February 2024 1, the dual primary endpoints of event-free survival (EFS) and major pathologic response (MPR) were met at the interim analyses of the RATIONALE-315 study. Results include: Article content Statistically significant and clinically meaningful improvement in MPR and pathological complete response (pCR) rates: 56.2% of NSCLC patients treated with TEVIMBRA in combination with chemotherapy before surgery achieved MPR compared to 15.0% of patients treated with chemotherapy in combination with placebo (difference: 41.1%; 95% CI: 33.2-49.1, p<0.0001) 40.7% of patients on the TEVIMBRA-based regimen achieved pCR, compared to 5.7% of patients treated with chemotherapy in combination with placebo (difference: 35.0%; 95% CI: 27.9-42.1, p<0.0001) Statistically significant EFS (HR [95% CI], 0.56 [0.40–0.79]; 1-sided P=0.0003) and trend for overall survival (OS) (HR [95% CI], 0.62 [0.39–0.98]; 1-sided P=0.0193) benefits favoring TEVIMBRA in early data. Consistent safety profile of the TEVIMBRA arm with that of individual therapies, with 72.1% of patients in the TEVIMBRA arm (vs. 66.4% in the placebo arm) experiencing grade ≥3 treatment-related adverse events (TRAEs) and 15.5% of patients in the TEVIMBRA arm (vs. 8.0% in the placebo arm) experiencing serious TRAEs. There were no new safety signals identified with this regimen, and the most common Grade 3 or 4 TRAEs (≥ 10%) in the TEVIMBRA arm were decreased neutrophil count and decreased white blood cell count. No impact on the feasibility and completeness of surgery, a key concern around neoadjuvant treatment. Article content Updated EFS and OS data from the pre-planned final analysis of RATIONALE-315 will be submitted for presentation at an upcoming medical conference. Article content 'TEVIMBRA is already approved in the EU across multiple settings in NSCLC, the most common form of lung cancer, and this positive CHMP opinion expands its potential to help patients earlier in their treatment journey,' said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. 'As the foundational asset of our solid tumor portfolio, TEVIMBRA continues to demonstrate its strength and versatility across the continuum of care, bringing us closer to our goal of delivering more comprehensive and effective cancer treatment to more patients.' Article content In lung cancer, TEVIMBRA is already approved in the EU for the first-line treatment of patients with squamous NSCLC, for the first-line treatment of patients with non-squamous NSCLC with PD-L1 high expression, for the treatment of patients with locally advanced or metastatic NSCLC after prior platinum-based therapy, and as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). It is also approved as a first-line treatment for patients with gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, as a first-line treatment for unresectable esophageal squamous cell carcinoma (ESCC), as a second-line treatment in ESCC after prior platinum-based chemotherapy, and as a first-line treatment for patients with nasopharyngeal carcinoma (NPC). Article content About NSCLC Article content Lung cancer is the most commonly diagnosed type of cancer and the leading cause of cancer-related death worldwide. 2 In Europe, lung cancer is the third most frequent cancer with 484,306 new cases diagnosed in 2022. 3 NSCLC accounts for 80–90% of all lung cancers 4, of which resectable NSCLC patients at diagnosis represent around 25–30% 5. Article content About TEVIMBRA (tislelizumab) Article content TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body's immune cells to detect and fight tumors. Article content TEVIMBRA is the foundational asset of BeOne's solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 21 registration-enabling studies. TEVIMBRA is approved in 46 countries, and more than 1.5 million patients have been treated globally. Article content Important Safety Information Article content This information is intended for a global audience. Product indications vary by region. Article content About BeOne Article content BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit and follow us on LinkedIn, X, Facebook and Instagram. Article content Forward-Looking Statement Article content This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the ability of TEVIMBRA to improve patient outcome and potentially alter the course of the disease and to potentially help patients earlier in their treatment journey; the ability of BeOne to deliver more comprehensive and effective cancer treatment to more patients; and BeOne's plans, commitments, aspirations, and goals under the heading 'About BeOne.' Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. Article content ______________________________ 1 Yue, D., et al. (2024, March). VP1-2024: RATIONALE-315: Event-free survival (EFS) and overall survival (OS) of neoadjuvant tislelizumab (TIS) plus chemotherapy (CT) with adjuvant TIS in resectable non-small cell lung cancer (NSCLC). Annals of Oncology, 35 (3), 332-333. 2 Bray, F., et al. (2022). Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians. 74(3):229-263. 3 Ferlay, J., et al. (2024). Global Cancer Observatory: Cancer Today. International Agency for Research on Cancer. 4 European Society of Medical Oncology. Non-small-cell lung cancer: A guide for patients. Article content Article content Article content Article content Contacts Article content Investor Contact Article content Article content Liza Heapes Article content Article content +1 857-302-5663 Article content Article content ir@ Article content Media Contact Article content Article content Kyle Blankenship Article content Article content Article content
CBC
21 hours ago
- CBC
Building peace through curiosity
Scholars at UBC Okanagan are analyzing an 800 year old Spanish book, looking for clues that might help us today. Francisco Pena is leading the project.
CTV News
a day ago
- CTV News
No funny gene: your humour has nothing to do with DNA
A new study says your sense of humour is not genetic. (Credit: Pexels) A new study is challenging the long-standing notion that a good sense of humour runs in the family. Led by Dr. Gil Greengross of Aberystwyth University and published in Twin Research and Human Genetics, the study is the first to examine the heritability of something known as humour production ability (HPA), the skill of creating humour that makes others laugh. 'People are different in their sense of humour, so not everyone is funny,' Greengross said in a video interview with 'Some are funnier than others, so an interesting question is what's the source of these differences.' Humour has long been considered a trait that promotes social bonding, reduces stress and increases attractiveness. But this new research, based on more than 1,300 adult twins from the U.K., suggests that, at least when it comes to producing jokes or witty remarks, the funny bone might not be inherited. To explore this, the researchers used the twin study method, comparing identical twins (who share 100 per cent of their genes) with non-identical twins (who share about 50 per cent). 'If identical twins are more similar to each other on a certain trait, then we can conclude that the trait has more genetic basis,' Greengross explained. Participants were asked to write humorous captions for two cartoons, then independent judges rated how funny the responses were. The participants also reported their overall health, assessed their own humour ability and rated the funniness of their co-twin. While intelligence, creativity and even humour appreciation have previously shown moderate to strong heritability, HPA did not. This suggests that growing up in different environments may have a much stronger impact on developing this skill than shared genes. 'To our surprise, we found very little to no genetic factor, and all the individual differences could be attributed to the two environmental factors: shared and non-shared environment,' Greengross said. The researchers, however, did find that self-rated humour had a strong genetic component. 'We asked each twin to evaluate how funny they think they are, and also they rated the co-twin — and their rating corresponds,' said Greengross, adding that there was a very strong correlation on how identical twins think about their sense of humour, but with non-identical twins, it was random. 'So, if maybe your parents think they have a great sense of humour, you're (also) more likely to think you have a great sense of humour,' he said. We're not as funny as we think Researchers say people's opinions of how funny they are does not line up with how funny others think they are. In one cited study, 93 per cent of men and 87 per cent of women rated themselves as having an average or above-average sense of humour, something Greengross describes as 'a statistical impossibility' and 'psychological bias.' 'We can't rely on self-reporting,' Greengross said. 'We can maybe ask your parents, your friends to say how fun you are, but that also has its own biases.' He said the best way is to get people to produce humour and then evaluate it separately, which is what the study did. The disconnect between real and perceived humour may be tied to personality traits. For example, extroverted people tend to rate themselves as funnier, while those who score high on conscientiousness tend to be less confident in their ability to make others laugh. Humour can come from family dinners Comedians who took the same cartoon caption task in earlier studies scored 'several orders of magnitude higher than the general population,' researchers said. But this doesn't necessarily mean their skills are genetic either. Toronto-based comedian Sarah Ashby says her comedic instincts have been shaped by 'a little bit of both' genes and environment. 'I lucked out,' Ashby said in a video interview with 'I grew up with a very funny family, that's kind of where I got my roasting style from, which is great. (At the) dinner table, everyone's roasting each other in front of the roast,' she said. Moving to a new environment changed her approach. 'I came to Toronto and started doing comedy here. I could definitely feel my humour change a little bit more and adapting,' Ashby said, saying humour shifts across social settings. 'Even at home with my roommates, I have hilarious jokes that we have all together, and then with my family, we have other jokes too,' she said. 'So, it's really fun to be able to bounce between different styles.' 'Humour is currency in the house' For identical twin comedians Randy and Jason Sklar, the idea that humour is learned rather than inherited isn't just a theory — it's their lived experience. 'Comedy or humour is currency in the house,' Jason said in an interview with 'If you want approval from your funny parent, and you do something funny, and then you're reinforced positively for that, you're going to do it again.' That environment is deeply woven into their family routines. 'We see that in our kids, and we encourage it in our kids,' Jason said. 'I think that's important. When our kids do something funny, we laugh at them, we give them credit, we get excited.' Despite being identical twins who perform as a single comedic unit, the brothers draw on very different lives as parents. 'I'm about to be an empty nester,' Randy said. 'Jay's got an 11-year-old kid… I'm in a different juncture in my life than he is. And, you know, two teenage daughters is a different animal than what he is going through.' Those different experiences feed their act — and they say they help explain how humour develops through lived experience. 'If we were around each other all the time and didn't have families and didn't have kids … I think that would be really suffocating and difficult,' Randy said. 'But… it certainly allows us to work together.' Their shared belief? A funny family culture makes a lasting impact. 'We both have instilled within our kids, the value of being funny amongst their friends and in whatever they do,' Randy said. 'A sense of humour will be at the core of who they are.' More research needed in finding funny Researchers also looked at other possible influences. Most participants in the study were women over 60, meaning potential age- or sex-related effects could have been missed. Some studies have found that heritability for cognitive traits decreases after age 65, while other traits may show stronger non-genetic influences as people age. Greengross also clarified that while twins were used to isolate genetic from environmental effects, the findings apply to the general population. 'Twins are used just because they have this unique genetic connection and they were the same age that allow us to do this comparison in a more controlled environment — as a result, (the findings) apply to the whole population.' Despite using a well-established method and a large sample, the authors note that 'humour ability is a multifaceted phenomenon' involving complex cognitive and personality traits that may not be easy to measure. They stress that small genetic effects can't be ruled out and that future studies, ideally with younger, more diverse samples, adding that different testing methods are needed to better understand whether humour ability has a heritable component at all.
