![]() Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure. PRINCETON, N.J.-(BUSINESS WIRE)- Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its type II variation application for Opdivo (nivolumab) in combination with chemotherapy for the neoadjuvant treatment of patients with resectable stage IB to IIIA non-small cell lung cancer (NSCLC), based on results from the CheckMate -816 trial. Opdivo -based treatments have shown clinical benefit in four Phase 3 trials in earlier stages of cancer Nivolumab (NIVO) + platinum-doublet chemotherapy (chemo) vs chemo as neoadjuvant treatment ( tx) for resectable (IB-IIIA) non-small cell lung cancer (NSCLC) in the phase 3 CheckMate 816 trial. AACR Annual Meeting 2021 10–15 April.If approved, the Opdivo regimen would be the first and only immunotherapy-based option authorized for use before surgery in patients with non-small cell lung cancer ( NSCLC) in the European UnionĪpplication based on CheckMate -816, the only Phase 3 trial to demonstrate improved event-free survival and pathologic complete response with an immunotherapy-based combination in the neoadjuvant setting of NSCLC Rash occurred in around 8% of participants, “however it was generally low grade”, and pneumonitis occurred in 1%, but both events were of grade 1 or 2 and did not prevent surgery, he highlighted.Ībstract CT003. ![]() ![]() Immune-mediated AEs in the combination arm “were generally infrequent and similar to what has been previously reported”, said Patrick Forde. ![]() Ten percent of patients in each group discontinued due to TRAEs there were no treatment-related deaths in the combination group versus three in the chemotherapy alone group. Treatment-related adverse events (TRAEs) of grade 3 or 4 occurred in 34% of patients in the combination arm and 37% of those in the chemotherapy alone arm, with neutropenia (8 vs 12%) and decreased neutrophil count (7 vs 11%) the most common events. The toxicity profile of nivolumab–chemotherapy “was consistent with the known profile of this combination regimen”, said the presenter. Patrick Forde noted that the addition of nivolumab to chemotherapy “did not compromise the feasibility of surgery”, with 83% of patients in the combination group undergoing surgery versus 75% of those in the chemotherapy alone group. The pCR benefit offered by the addition of nivolumab to chemotherapy was maintained regardless of patient age or sex, disease stage, histology, PD-L1 expression and tumour mutational burden, reported Patrick Forde, adding that “the study continues to mature” for the other primary endpoint of event-free survival.Ĭombining nivolumab with chemotherapy also significantly improved the secondary endpoint of major pathological response (≤10% residual viable tumour cells), at a rate of 36.9% versus 8.9% for chemotherapy alone (OR=5.70).Īnd the exploratory endpoint of objective response rate, assessed by blinded independent review at the presurgical scan, was also higher in the combination than the chemotherapy alone group, at 54% versus 37%. This equated to a significant odds ratio (OR) of 13.94 in favour of the combination. The trial included 358 patients with a new diagnosis of stage IB–IIIA, resectable NSCLC and no known sensitising alterations in EGFR or ALK participants were randomly assigned to receive three cycles of nivolumab 360 mg alongside platinum-doublet chemotherapy, both given every 3 weeks, or chemotherapy alone.Īfter a minimum follow-up of 7.6 months, the co-primary endpoint of pCR – defined as 0% viable tumour cells in both primary tumour and lymph node samples by blinded independent pathological review – was 24.0% for the patients who received nivolumab plus chemotherapy and 2.2% for those given chemotherapy alone. “And nivolumab in combination with chemotherapy represents a potential new neoadjuvant option for these patients”, he added. “CheckMate 816 is the first phase III study to show benefit of an immunotherapy plus chemo combination for resectable non-small-cell lung cancer”, said presenting author Patrick Forde, from the Johns Hopkins Kimmel Cancer Center in Baltimore, Maryland, USA, at the virtual AACR Annual Meeting 2021. MedwireNews: Among patients with operable non-small-cell lung cancer (NSCLC), supplementing neoadjuvant platinum-doublet chemotherapy with nivolumab leads to a significant boost in pathological complete response (pCR) rate, indicate trial data. Author By Shreeya Nanda, Senior medwireNews Reporter
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These cookies ensure basic functionalities and security features of the website, anonymously. ![]() Necessary cookies are absolutely essential for the website to function properly. ![]() ![]() Bus圜ontacts alternativesĪs with any software, Bus圜ontacts is not perfect. It also syncs contacts with a few cloud services. Share contacts Bus圜ontacts allows users to share address books with other users of this very app in a preferred way. Owning the two apps, users can arrange and follow up the events/tasks associated with a contact. Users can benefit from its integration with Bus圜al, a calendar app from the same developer. Integrate with Bus圜al Bus圜ontacts is not your average contact manager app. Integrate with social networks Bus圜ontacts supports syncing with some social networking platforms and CardDAV services, helping users gather the information about a contact from different sources. Smart Filters allows users to create and save custom filters. 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![]() ![]() But when there’s a show-when picnic basket-toting concertgoers amble up the hill and fill amphiteater’s 18,000 seats-it’s simply magical. The posh neighborhood manages to keep things pretty casual, so feel free to bike over from the beach and peruse the storefronts.The Hollywood Bowl is beautiful even when it’s empty (when there’s no performance, the iconic venue doubles as a county park). While Venice’s claim to fame may be its beach culture, the ’hood’s most stylish block, Abbot Kinney Boulevard, has some of the city’s best boutiques, galleries, restaurants and bars (Felix and Gjelina, most notably). Watch from the fences and you’re sure to see a bustling scene, oftentimes with a skate video shoot in the process. While this more recently constructed skate park, built in 2009, doesn’t really factor into that history, it has quickly become easily the most iconic skateboarding spots-chalk that up to its photogenic palm trees and location only steps from the shore. When surfers were bored with flat waves-like Venice’s legendary Z-Boys-they took to the sidewalks and thus birthed skateboarding in the process. Watch the bustling scene at the Venice Skate Park ![]() Their local author selection is right up front, so check out the local talent before perusing the aisles, where you’ll find a number of hard-to-find independent imprints, along with the more usual suspects. Surrounded by bad beach food and throngs of people, this little shop has been an oasis of literary calm for four decades. Flip through some pages at Small World Books You can explore the space on Saturdays from 1 to 4pm-you’ll just need to make a reservation first. But over the course of a decade, the couple transformed their live-work space into a spectacular collage of colorful tiles, stone and clay wares. When artists Cheri Pann and Gonzalo Duran first moved into their Venice home, it was nothing more than a simple, rather drab house. Since then, it’s morphed into a voyeuristic gym for chiseled bodybuilders, where curious onlookers can watch from outside the fence of the postmodern, dumbell-shaped building or from the stands at the competition stage. ![]() When the original Muscle Beach in Santa Monica disappeared in the ’60s, this competing spot in Venice arose to fill the void. Plus, the beach here is particularly soft and wide, with great views of the mountains. It’s not entirely without its charms: It’s always fun to watch the wheeled action at the skatepark and there are a couple of worthwhile eateries, like the Waterfront and the nearby Gran Blanco. Unlike its posh neighbor to the north, though, Venice is far more stocked with T-shirt stands, pot shops and questionable street performers, alongside the pumped-up gym obsessives who work out at Muscle Beach. This pedestrian walkway effectively continues from the southern end of Santa Monica Beach without a break. If there’s one thing the Venice Boardwalk is good for, it’s people watching. People watch on Venice Beach and the Boardwalk Though you won’t find boat rentals anywhere along the canals, you can bring your own non-motorized vessel to tour the neighborhood at water level (enter via the launch ramp at Venice Boulevard). Take a stroll through these three canal-lined blocks of Dell Avenue-hence the name, Venice-and you’ll discover an idyllic scene: arching pedestrian bridges, charming beach houses, bunches of ducklings and the occasional paddle boarder. The Venice Canals offer a completely different side of the famed beachfront neighborhood. Whether you’re visiting from out of state or just across town, make sure to add these things to do in Venice to your itinerary. But there’s so much more to see beyond the boardwalk, from idyllic canals to quiet patches of sand that rank among L.A.’s best beaches. Many visitors make a beeline for the grungy Venice Boardwalk, admittedly an iconic L.A. Look past the T-shirt shops and street performers and you’ll find enough things to do in Venice that are downright pleasant and-dare we say-borderline charming. Get to know L.A.’s eclectic beachfront neighborhood with these things to do in Venice, both on and off the boardwalk. |
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