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- European Commission approves Roche’s Tecentriq in combination with Abraxane for people with PD-L1-positive, metastatic triple-negative breast cancer
Roche today announced that the European Commission has approved Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression (≥1%) and who have not received prior chemotherapy for metastatic disease. Roche’s VENTANA PD-L1 (SP142) Assay is now CE marked and commercially available in the European Union as an aid for identifying patients with TNBC eligible for treatment with the Tecentriq combination.
“For the past 30 years, we have been dedicated to transforming the lives of people with breast cancer. Now, we are pleased to build on this foundation with the news that the first immunotherapy treatment for triple-negative breast cancer is available to people in Europe with PD-L1-positive, metastatic triple-negative breast cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “The European approval of this Tecentriq combination represents a significant step forward in the treatment of this aggressive breast cancer, where the unmet medical need is great.”
This approval is based on the results from the Phase III IMpassion130 study. Progression-free survival (PFS) results demonstrated a statistically significant benefit for Tecentriq in combination with nab-paclitaxel and showed that Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or death (PFS) by 38% compared with nab-paclitaxel alone (median PFS=7.5 vs 5 months; hazard ratio [HR]=0.62, 95% CI: 0.49-0.78, p<0.0001) in people who were tested positive for PD-L1 expression on tumour-infiltrating immune cells. At the second interim analysis, Tecentriq and nab-paclitaxel showed a clinically meaningful overall survival (OS) improvement of seven months vs placebo and nab-paclitaxel in the PD-L1-positive population (median OS=25.0 vs 18.0 months; HR=0.71, 95% CI: 0.54 –0.93). OS results in the PD-L1-positive population were not formally tested due to the hierarchical design of the study as statistical significance was not met for OS in the intention-to-treat (ITT) population (median OS=21.0 vs 18.7 months; HR=0.86, 95% CI: 0.72–1.02, p=0.078).
The assessment of PD-L1 on tumour-infiltrating immune cells is essential for identifying the patients with TNBC benefiting from this Tecentriq combination. PD-L1 expression status in the IMpassion130 study was assessed by the VENTANA PD-L1 (SP142) assay.
Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. The nature and incidence of severe adverse events (SAEs) and Grade 3–4 adverse events (AEs) were consistent with the known safety profiles of the individual study drugs or the underlying disease. SAEs were reported in 23% of people receiving Tecentriq plus nab-paclitaxel compared to 18% of people receiving chemotherapy alone. Grade 3–4 AEs were reported in 49% of people receiving Tecentriq plus nab-paclitaxel compared to 42% of people receiving chemotherapy alone.
Currently, there are seven ongoing Phase III studies investigating Tecentriq in TNBC, including early and advanced stages of the disease.
the 2019 Asia-pacific pharma IP Leader Summit will be held in Beijing on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.
Official registration and consultation channels:
Contact：Ann
Phone: 021-65650305
From :businessinsuranceU.S. commercial property/casualty rates rose 5% on average in the fourth quarter of 2019, up from 4% in the third quarter, reflecting insurers’ intent to continue to increase prices across most lines, online insurance exchange MarketScout Corp. said Monday.“Auto rate increases have been up all year long; however D&O (directors & officers) and professional rate increases have spiked significantly in the fourth quarter,” Richard Kerr, CEO of MarketScout Corp. said in a statement.Insurers are carefully analyzing their property exposures using catastrophe modeling tools, he said. “We expect many of the major property catastrophe insurers to curtail their 2020 writings in California brush and East and Gulf Coast wind areas. Naturally, this will result in higher rates to insureds,” Mr. Kerr said.D&O liability rates increased by 8.25%, while commercial auto increased 8% in the quarter, and professional liability rates were up 6%, and umbrella/excess rates were up 5.5%, according to MarketScout.Commercial property rates increased 5.25% in the quarter, and business interruption rates were up 5%, while all other lines showed smaller increases, except for workers compensation, where rates fell 1%, MarketScout said.By industry class, transportation and habitational saw the highest average rate increases at 9% and 8.25% respectively, MarketScout said.Large accounts – those with $250,001 to $1 million in premium – saw a rate hike of 5.5% in the fourth quarter, as did jumbo accounts, which have more than $1 million in premium. Small accounts – those with up to $25,000 in premium – were up 5%, while medium accounts – those with $25,001 to $250,000 in premium – were up 4.5%.The “steady trend” of upward rates reflects insurers’ plans to continue increasing prices across all lines except for workers compensation, MarketScout said.Organizer：China Insurance Digital & AI Development 2020Web:http://en.zenseegroup.com/p/560573/Contact:Ann 021-65650305
From :insurancejournalIt was a relatively quiet year for the Southeast in terms of major catastrophes compared with 2018 when Hurricane’s Michael and Florence caused major damage in the region. This year, Hurricane Dorian sideswiped the Southeast coast and made landfall on the Outer Banks of North Carolina but most of the area was spared. Still, Aon said economic damage in the U.S. and Canada was poised to approach a combined $1.5 billion.Florida spent the year recovering from Hurricane Michael, which was upgraded to a Category 5 storm by NOAA in April. Florida officials have repeatedly called on the insurance industry to speed up the recovery process, with nearly 12% of claims still open a year after the storm hit.Organizer：China Insurance Digital & AI Development 2020Web:http://en.zenseegroup.com/p/560573/Contact:Ann 021-65650305
From:businessinsuranceeinsurance renewals at Jan. 1, 2020, mainly saw single-digit increases, with some exceptions, according to reports by reinsurance brokers released Thursday.Willis Re, the reinsurance brokerage of Willis Towers Watson PLC, and Guy Carpenter & Co. LLC, a unit of Marsh & McLennan Cos. Inc. both reported that year-end reinsurance renewals varied by account and region, but the retrocessional reinsurance was under pressure.Rates on line for property catastrophe reinsurance programs remained stable and property per risk pricing was driven by individual program performance, the Willis report said.Although some Lloyd’s of London syndicates took firm positions on rate increases and the London market authorized capacity decreased, that capactiy was replaced by new capital and a strong supply from other markets, Willis Re said.U.S. loss-free accounts renewed at flat to up 10% while those with losses saw increases of 10% to 50%, the Willis Re report said, which was among the largest increases. Property catastrophe accounts without losses renewed at flat to up 5%, while loss hit accounts were up 10% to 20%, Willis Re said.According to the Guy Carpenter report, the brokerage’s global property catastrophe rate on line index rose 5% in 2019.According to the Willis Re report, other large increases were seen in Central and Eastern Europe, where property programs with losses saw increases of 5% to 20%, and Canada, where such accounts renewed up 10% to 40%.Most other regions and countries saw property increases in the single or low double digits, the report said.The Jan. 1 renewals saw some “difficult” negotiations, according to a letter in the report from James Kent, global CEO, Willis Re.The Guy Carpenter report said the reinsurance market was “asymmetrical,” adding “this is certainly not a one-size-fits-all market” and while overall capacity remained adequate, “allocated capacity tightened notably in stressed classes.”Dedicated reinsurance capital rose 2% in 2019 and the year saw approximately $60 billion in global insured catastrophe losses, according to Guy Carpenter, which was significantly lower than 2017 and 2018.Alternative capital, however, contracted by approximately 7% percent “as investors were more cautious with new investments after assessing market dynamics and pricing adequacy,” Guy Carpenter said.The retrocession market “was challenged … by trapped capital, a lack of new capital and continued redemptions from third-party capital providers,” a statement issued with the Guy Carpenter report said.However, significant retrocession providers returned to the market in the past two weeks, Willis Re said.Organizer：China Insurance Digital & AI Development 2020Web:http://en.zenseegroup.com/p/560573/Contact:Ann 021-65650305
Major information technology companies in India are running the risk of termination of their $1 billion contracts following Boeing Co.’s decision to halt the production of its 737 Max jets, MoneyControl reported citing the Business Standard. Companies like Tata Consultancy Services Ltd., Infosys Ltd., HCL Technologies Ltd., Cyient Ltd. and L&T Technology Services Ltd. have outsourcing contracts with Boeing or its suppliers and Boeing’s jet crisis is expected to affect these IT companies in the short run.From:businessinsuranceOrganizer：China Insurance Digital & AI Development 2020Web:http://en.zenseegroup.com/p/560573/Contact:Ann 021-65650305
France-based eyewear maker Essilor International S.A. has discovered fraudulent activities at one of its factories in Thailand that could cause €190 million ($213 million) in financial losses to the company, The Irish Times reported citing Reuters. The company has filed complaints in Thailand and has fired all the involved employees. It hopes to recover the losses from frozen bank accounts, insurance and lawsuits.Organizer：China Insurance Digital & AI Development 2020Web:http://en.zenseegroup.com/p/560573/Contact:Ann 021-65650305
