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Web Release
6 days ago
- Business
- Web Release
Lilly's Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) BTK inhibitor, met its primary endpoint in a head-to-head Phase 3 trial versus Imbruvica (ibrutinib) in CLL/SLL
Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 BRUIN CLL-314 clinical trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, versus Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). This study enrolled patients with treatment-naïve CLL/SLL and those who had been previously treated but were BTK inhibitor-naïve. The study met its primary endpoint of non-inferiority on overall response rate (ORR) as assessed by an independent review committee (IRC) in both the pre-treated and intent-to-treat populations. ORR favored pirtobrutinib with a nominal P-value for superiority1 (p <0.05). Progression free survival (PFS), a key secondary endpoint, was not yet mature at this analysis, but was trending in favor of pirtobrutinib. A formal PFS analysis testing for superiority is planned at a future analysis. No detriment was observed for overall survival (OS). BRUIN CLL-314 is the first ever head-to-head trial versus ibrutinib in CLL to include treatment-naïve patients. This important subpopulation (n=225) had the longest follow-up and a particularly pronounced PFS effect size in favor of pirtobrutinib. The overall safety profile of pirtobrutinib in BRUIN CLL-314 was similar to previously reported trials. Detailed results will be presented at a medical congress later in 2025. 'We launched the pirtobrutinib randomized development program with an ambitious suite of clinical trials, including head-to-head studies against modern standards of care and examinations of patient populations that reflect real world use, such as BTK inhibitor-pretreated patients,' said Jacob Van Naarden, executive vice president and president of Lilly Oncology. 'These data mark the second positive Phase 3 study in the program, as we continue to build evidence supporting the potential role of pirtobrutinib in treating people with CLL/SLL and hopefully enabling future regulatory approvals that allow physicians to use the medicine in various disease settings, whether treatment-naïve or BTK inhibitor-pretreated.' These data build on the previously reported positive results from the BRUIN Phase 1/2 trial and the Phase 3 BRUIN CLL-321 trial, the first randomized, controlled study ever conducted in an exclusively post-covalent BTK inhibitor population. The BRUIN CLL-313 Phase 3 study of pirtobrutinib versus chemoimmunotherapy in treatment naïve CLL/SLL is expected to read out later in 2025 and combined with the results of BRUIN CLL-314, will form the basis of regulatory submissions globally. For more information on the BRUIN Phase 3 clinical trial program, please visit
The Star
20-07-2025
- Business
- The Star
Bali to ban production of plastic sachets in 2026
A fisherman pulls his boat out to sea on March 20, 2024, across waste that covers much of Kedonganan Beach in Badung, Bali. Kedonganan is one of Bali's beaches most polluted with plastic materials. - Photo: Antara file BALI, (Indonesia): The Bali provincial administration plans to ban the production of small plastic packaging, or sachets, starting in 2026 as a response to suggestions from environmentalists after banning the production of under-1-liter bottled water. 'I support it fully. This has been through studies on the small-size sachets, whether it [the ban] will be decided this year or next year [in 2026],' Bali Vice Governor I Nyoman Giri Prasta said in Denpasar on Tuesday, as quoted by Giri said the provincial administration was still focusing on the ban of bottled water first. He added there was a possibility that a ban on other plastic packaging would come in 2026. 'We have discussed this, there will be a decision later,' he said. The former Badung regency head said that Bali Governor Wayan Koster was very wise in banning plastic packaging. The decision would still allow French company Danone to use up the bottled water production that has already been distributed. 'It means being visionary, [so that] our descendants [can] see Bali clean and green,' the politician from the Indonesian Democratic Party of Struggle said. Previously, the Nusantara River Research Agency (BRUIN) suggested that Koster also target other plastic packaging, not only banning bottled water. BRUIN coordinator for waste census, Muhammad Kholif Basyaiban, said the Bali provincial administration had to refer to Law No. 18/2008 on Waste Management, which stipulates the responsibility of producers in waste processing. There are also other regulations such as Environmental and Forestry Ministerial Decree No. 75/2019. 'The reference for circulars, government regulation, provincial bylaws and gubernatorial regulations is the Waste Management Law and the ministerial decree, which do not discriminate certain [kinds of] plastic waste but all kinds of plastics,' Kholif said in a written statement on Monday. In 2024, Bali produced 1.2 million tonnes of plastic waste, according to the National Waste Management Information System. Plastic fairness Separately, two bottled water producers in Bali expressed objections to the ban on producing and distributing bottled water in containers less than 1 liter as stipulated by Bali Gubernatorial Circular No. 9/2025 on Clean Bali Movement. 'Environmental conservation policy in Bali is indeed important [and] urgent but cannot be applied unilaterally without a dialogue mechanism and legal protection for local businesses,' CV Tirta Taman Bali president director I Gde Wiradhitya Samuhata said on Monday. Wiradhitya said the objection was accompanied by the company's official stance and legal analysis on the gubernatorial circular. 'We have compiled a juridical analysis and will send the official stance to the Aspadin [Indonesian Bottled Water Association] central executive board in Jakarta as a constructive contribution to manage the relations between businesses, customary society and regional policy,' he said, as quoted by Antara news agency. He revealed that Balinese bottled water companies considered customary villages not only as partners but the soul of their businesses. He also agreed with environmental conservation efforts but said the solution should focus on waste management instead of banning plastic packaging production. He said the Bali administration should shift from symbolic banning to reform the waste management system based on recycling incentives, public education and producers' responsibilities. Meanwhile, president director of PT Tirta Mumbul Jaya Abadi, Nyoman Arta Widyana, said that instead of only banning bottled water under 1 liter, the provincial administration should also ban all plastic packaging to be fair. 'For example, when we want to buy cooking oil, sugar, coffee and candy, all these items use plastic. But it seems that only we [bottled water producers] are blamed for causing plastic waste,' he said. Arta said it was not fair if the problem of plastic waste was only blamed on bottled water producers when they already used PET (polyethylene terephthalate) bottles and PP (polypropylene) cups which could be easily recycled. - The Jakarta Post/ANN
