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- 2025-12-25 01:07:40
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- 2nd generation EGFR TKI Vizimpro can be prescribed in Big 5
- by Eo, Yun-Ho Jul 06, 2022 05:47am
- Pfizer's second-generation EGFR TKI Vizimpro has settled in the Big 5 General Hospital. According to related industries, Pfizer's EGFR TKI Vizimpro recently passed all five major medical institutions such as Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital. It was completed at major medical institutions nationwide, including the National Cancer Center, Seoul National University Bundang Hospital, Pusan National University Hospital, Chungbuk National University Hospital, and Chungnam National University Hospital. Vizimpro, which was listed on the insurance benefit list in December 2021, was designated as a priority review target by the US FDA in January 2018 and approved in September of the same year. Currently, it is licensed and used in the United States, the European Union, and Japan. In Korea, Vizimpro was approved as the first treatment for local progressive or metastatic EGFR mutation non-small cell lung cancer in February last year. VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung canker (NSCLC) with epidermal growth factor acceptor (EGFR) exection 19 deployment measurement 2185 or 85. Currently, EGFR TKI such as AstraZeneca's Iressa, the first-generation drug, Roche's Tarceva, AstraZeneca's Tagrisso, and Yuhan's Leclaza are prescribed in Korea. Competition to attract prescriptions for Giotrif and Vizimpro, the second-generation drugs, is expected to intensify in the future. The efficacy of Vizimpro has been demonstrated through ARCHER 1050, a phase 3 clinical trial. The study directly compared Vizimpro with Iressa, the first-generation drug, and a total of 452 non-small cell lung cancer patients were registered. Progression-Free Survival (PFS) reduced the risk ratio by 41% compared to Iressa, and the median PFS value was 14.7 months for Vizimpro, ahead of the Iressa administration group of 9.2 months. The results of the side effects of Vizimpro were poor. The common severe side effects of Grade 3 or higher were 14% acne and 8% diarrhea in the Vizimpro administration group, and 8% liver enzyme abnormalities occurred in the Iressa administration group. 60% of the Vizimpro administration group needed dose adjustment as a side effect.
- Company
- There are many complaints about the revaluation of generics
- by Chon, Seung-Hyun Jul 06, 2022 05:46am
- Pharmaceutical companies complain of unnecessary waste of money on products being sold without problems. Pharmaceutical companies are struggling ahead of the general drug price revaluation. There are many concerns that the biological equivalent test, which was conducted with the aim of maintaining drug prices, could lead to a reduction in drug prices due to delays in submitting data due to COVID-19. The pharmaceutical industry continues to ask health authorities to extend the deadline for submitting data, but it has not yet been carried out. According to the industry on the 25th, the HIRA recently held a briefing session on the revaluation of the upper limit of registered drugs and proposed a schedule to receive revaluation data from October 1st to the end of February next year. The schedule for the generic drug price evaluation announced by the MOHW two years ago has been specified. It announced a plan to reevaluate the upper limit of drugs that maintain the previous drug price by submitting data on conducting biological equivalent test and using registered raw materials drugs by February 28, 2023. This is a follow-up measure to apply the new drug price system, which took effect in July 2020, to the registered generic. In the revised drug price system, generic products can receive an upper limit of 53.55% compared to the original before the patent expires only if they meet both the requirements for direct biological testing and the use of registered raw materials. Each time one requirement is not met, the upper limit is lowered by 15%. Once the pharmaceutical companies' submission of data is completed, they will go through procedures such as practical review and pharmaceutical companies' objections, and from July next year, generic drugs that have not submitted data will be lowered. Requirements for the use of registered raw materials can be met through the replacement of raw material drugs. Pharmaceutical companies are in a situation where they have to choose between accepting drug price cuts or maintaining drug prices through performing biological tests. Pharmaceutical companies are actively developing biological equivalent tests for licensed generics. The goal is to avoid drug price cuts through approval for change by creating generic through pharmaceutical research, conducting biological equivalent tests, and obtaining equivalent results. If the consignment manufacturing is converted to its own manufacturing and the permission is changed, it is using a strategy that meets the requirements of conducting biological equivalent test. However, COVID-19 has recently acted as a variable. Pharmaceutical companies faced difficulties in recruiting subjects as the number of COVID-19 confirmed patients exploded during the biological equivalent test. It is also said that there are frequent situations in which people registered as subjects leave due to COVID-19 confirmation. Due to the lack of subjects, it is inevitably difficult to perform a normal biological equivalent test. Looking at the drug equivalence standard, the biological equivalent test should be conducted on at least 12 people in the test group and the control group, respectively. This means that a biological equivalent test cannot be established unless a total of 24 or more subjects are registered. The test group or control group can be increased by recruiting additional subjects, in which case the biological equivalent test schedule is inevitably delayed. As the requirements for subjects are already strict, the biological equivalent test subjects recruitment difficulties are prolonged. According to the revised pharmaceutical affairs law, which passed the plenary session of the National Assembly in November 2018, only those who have not participated in clinical trials within six months before the test date should be selected as eligible. As it doubled from the previous three months to six months, the number of participants in the biological equivalent test has also decreased significantly. For this reason, pharmaceutical companies have recently asked health authorities to extend the deadline for submitting revaluation data through various channels, but no clear position has been made yet. Oh Chang-hyun, head of the insurance drug division at the MOHW, who attended the briefing session, said, "It is difficult to say for sure because the MFDS has yet to discuss the suspension of data submission." Moreover, pharmaceutical companies are in desperate need of a delay in submitting biological equivalent test data as they have endured a significant reduction in drug prices due to the abandonment of the biological equivalent test by consignment generic. Pharmaceutical companies have inevitably accepted drug price cuts if it is difficult to change the manufacturer of consignment generics by themselves, signaling huge losses. In July 2020, the MFDS officially banned the sale and recovery of non-equivalent products as a result of the biological equivalent test for maintaining drug prices. As a result of the biological equivalent test, the principle was established that measures such as recovery of non-equivalent products will be implemented based on the risk of grade 3. Other consignment products produced at the same manufacturing facility as generic, which has been judged to be unequal, are also likely to be recalled. With trust A supplying the same generics to 10 consignment companies, the logic is that if one of the products is non-equal, the other nine consignment generics may also be suspected of non-conformity. For pharmaceutical companies, they have no choice but to choose to accept the reduction of the drug because the risk they have to take when they start the biological equivalent test is high. It is not possible to try to convert into a company because there are no manufacturing facilities. Many companies cannot convert drugs that require separate factories from other drugs, such as PCNs, hormone drugs, biological drugs, Cephalosporins, and cytotoxic anticancer drugs, because not many companies have manufacturing facilities. Products that require special formulation manufacturing facilities such as soft capsules are also not easy to convert consignment generics' direct production. Pharmaceutical companies continue to complain that the license is an unnecessary waste of money to carry out the biological equivalent test of generic. This is because it is wasteful to conduct biological equivalent tests at a cost to maintain drug prices even though they are already being sold without problems after being recognized for safety and efficacy by the government.
- Company
- Sanofi & MDsquare co-promote Digital Healthcare Business
- by Jul 05, 2022 05:58am
- Sanofi Korea Corporation announced on the 4th that it held a (MOU) signing ceremony with MDsquare to promote digital healthcare business on the 30th of last month. With this agreement, Sanofi provides chronic disease management and prevention information, and MDsquare develops premium health care programs to cooperate so that patients with chronic diseases can effectively manage their health. It is planning to expand cooperation plans through connection with digital healthcare products to be launched in the future and joint promotions of both companies' products. As the first step to discover and promote new businesses, MD Square provides MDCare, a premium health care service, to Sanofi executives and employees. MDCare is a non-face-to-face treatment service that helps manage diseases of elderly chronic diseases, and can receive periodic health care and health counseling through professional medical staff. The opinions and reviews delivered by Sanofi executives and employees after experiencing MDCare in person will be reflected to enhance service and improve accessibility. Sanofi-Aventis Korea CEO Bae Kyeong-eun said, "Through this agreement, we will be able to get closer to the company's goal of improving the health of patients through scientific innovation that combines digital and data." "The year 2022 will be a year to promote relationships with Korean digital healthcare stakeholders by exploring various innovative collaboration opportunities in Korea," she said. Oh Soo-hwan, CEO of MDsquare, said, "Starting with this collaboration, we will find various ways to help more patients with MDCare's premium health care service."
- Company
- RDK introduces monkeypox PCR test kits to Korea
- by Jul 05, 2022 05:58am
- Pic of Roche Diagnostics Korea On the 4th, Roche Diagnostics Korea announced that it had introduced PCR diagnostics kits for the detection of the monkeypox virus in Korea. The three kits that were introduced to Korea this time -▲ LightMix Modular Orthopox Virus, ▲ LightMix Modular Monkeypox Virus, and ▲ LightMix Modular Orthopox Virus typing1- were developed by Roche and its subsidiary TIB Molbiol in May this year. The first kit detects all forms of orthopoxviruses. The second kit, LightMix Modular Monkeypox Virus, targets and diagnoses all monkeypox viruses, and the third kit, LightMix Modular Orthopox Virus typing1, checks whether the subject has the monkeypox virus while detecting orthopoxviruses. All three tests may be conducted using Roche Diagnostics Korea’s equipment LightCycler 480 II2 or Cobas Z 4803 analyzer. The diagnostic kits are in use for research in many countries and have also been introduced to Korea for research purposes. Monkeypox, which had been a rare endemic that typically occurs in Central and West Africa, has been rapidly spreading to various countries around the world after the first case was reported in the UK on May 7. Recently, monkeypox has been spreading to non-endemic areas outside Africa, including the US, Europe, and the Middle East. In Korea, the authorities have raised the country’s risk alert level for monkeypox from “of interest” to “caution” after the first patient was confirmed in Korea. In June 2022, the authorities designated monkeypox as a Class 2 infectious disease and reinforced monitoring for the disease. Kit Tang, General Manager of Roche Diagnostics Korea, said “Roche Diagnostics has quickly released a diagnostics kit for the monkeypox virus just as it had released a diagnostics kit for COVID-19 immediately after its outbreak. Innovative diagnostic solutions play a key role in controlling infectious diseases, and we look forward to working with HCPs and institutions in Korea to contribute to improving public health and its response to the monkeypox virus.”
- Company
- CKD voluntarily discontinues P3T on its COVID-19 therapy
- by Kim, Jin-Gu Jul 04, 2022 05:55am
- Chong Kun Dang issued a public notice on the 1st that it will discontinue the Phase III trial on its CKD-314 (Nafabeltan Inj.) it had been developing as a COVID-19 treatment. Chong Kun Dang explained, “We found it difficult to conduct a clinical trial to identify the patients’ rate of progression to severe disease due to the reduced incidence of COVID-19 and the majority receiving inoculation in Korea. Therefore, in consideration of expert opinion and the comprehensive situation, we decided to discontinue the trial.” Chong Kun Dang started the development of the COVID-19 treatment in earnest after receiving approval for its Phase 2 trial protocol on Nafabeltan in July 2020. The trial was designed as a drug repositioning trial to assess the possibility of using Nafabeltan, a drug that was already approved as a treatment for acute pancreatitis, to treat COVID-19. Afterward, the company started to conduct a large-scale Phase III trial on 600 patients globally in April last year. However, this April, the company filed an application to switch the global trial to a domestic trial. As such, news of discontinuation or early termination of clinical trials has been continuing from COVID-19 treatment developers in Korea. After Celltrion announced its discontinuation of developing its inhaled COVID-19 antibody therapy on the 28th of last month, Crystal Genomics also announced the early termination of its trial on the morning of the 1st of this month. With 3 companies announcing discontinuations just this week, the pharmaceutical industry believes more announcements are waiting to come in the near future. With Chong Kun Dang’s discontinuation, 17 companies are currently officially conducting clinical trials to treat COVID-19 in Korea.
- Company
- Lotte Biologics cooperates with Sigma
- by Jul 04, 2022 05:54am
- Lotte Biologics announced on the 1st that it has signed a business agreement with Millipore Sigma, Merck's North American life science division to strengthen its bio business capabilities. With this agreement, the two companies will cooperate in promoting new biopharmaceutical businesses such as next-generation treatments and expanding Syracuse factories in the U.S. Millipore Sigma is a life science division in North America operated by Merck, a global science and technology company based in Germany. Lotte Biologics will receive overall technical support related to its bio business, including manufacturing solutions and human resource training, from Millipore Sigma. Lotte Biologics expects to speed up its bio business through the development of biopharmaceutical processes owned by Merck Group's life science division and exchange of experience in GMP manufacturing for more than 30 years. Merck Life Sciences Division has supported more than 280 biopharmaceutical companies to enter the market and has experience in launching more than 100 GMP drugs since 2012. Lotte Biologics is expanding its external activities to upgrade its bio business by attending events hosted by foreign government agencies and striving to raise global awareness. CEO Lee Won-jik attended "JOIN SWEDEN SUMMIT 2022" held in Stockholm, Sweden from the 20th to the 21st of last month and had opportunities to promote Lotte Biologics' business and exchange globally. JOIN SWEDEN SUMMIT 2022 is an international political and business conference in which more than 100 global business leaders, Swedish governments and corporate representatives from major Swedish trading partners, including Korea, gather together to explore new collaboration and investment possibilities. Global Big Pharma and promising bio-ventures such as Gilead, Roche, Biogen, Johnson & Johnson, Sanofi, AstraZeneca, Pfizer, and BioArtic participated in the event. Lotte Biologics conducted exchanges with the companies to find ways to cooperate with each other and establish a network of potential customers. CEO Lee said, "We will strengthen cooperation with global bio companies to improve the quality reliability of products produced after the acquisition of Syracuse plants is completed. We plan to increase global awareness and focus on production volume orders by attending major biopharmaceutical events."
- Company
- Tdap vaccine Adacel can be prescribed in general hospitals
- by Eo, Yun-Ho Jun 30, 2022 05:53am
- Sanofi Pasteur's new Tdap vaccine Adacel can be prescribed in general hospitals. According to related industries, the Tdap vaccine for teenagers and adults aged 11 or older has passed the DC of 100 medical institutions, including Seoul National University Hospital, Korea University Guro Hospital, Gangbuk Samsung Hospital, and Hallym University Gangnam Sacred Heart Hospital. As GSK's supply of Boostrix was suspended last year, additional prescriptions have recently been carried out rapidly. Adacel is a booster vaccine against pertussis by adding five preventive ingredients for pertussis to the existing Td vaccine that prevents diphtheria and tetanus. Re-vaccination of the DTap vaccine is recommended 5 years after the last Td vaccine, and it was found that the local side effects did not increase even if Adacel was vaccinated 2 years after the last Td vaccine. DTap vaccine is recommended to be vaccinated five times from 2 months old to 4 to 6 years old, and after that, it is recommended to be vaccinated once every 10 years from the age of 11 to 12. The number of cases of pertussis has increased since the 2000s in developed countries with high vaccination rates, increasing the need for additional vaccinations. According to U.S. CDC data, 75% of pertussis, especially in newborns, is known to be transmitted through family members, including parents. GSK announced at the end of last year that the supply of vaccines such as Rotarix, Cervarix, Synflorix, Menveo, Havrix, Priorix (MMR vaccine), Boostrix (Tdap vaccine), Infanrix-IPV, IPV/Hib (DTaP vaccine) was suspended. It is known that there was a document error in CTD. GSK added that it would resume shipping after submitting supplementary documents to the MFDS as it was a document error, not a quality issue.
- Company
- 16 companies including Amgen launch industrial union
- by Eo, Yun-Ho Jun 30, 2022 05:52am
- A new confederation of unions centered around multinational pharmaceutical companies is soon to be launched in Korea. According to industry sources, a National Pharmaceutical & Bio Labor Union (NPU) under the Federation of Korean Trade Unions will be launched on July 5th. Labor unions of 16 companies, including labor unions from Korean subsidiaries of MNCs like Novo Nordisk, Bayer, Amgen, Novartis, Viatris, Janssen, Pfizer (will transition to industrial union), and those of Sanofi-Aventis, Alvogen, Opella Healthcare, Merck, Boehringer Ingelheim, AstraZeneca, GSK, and Hyundai Pharm will become affiliated with NPU. According to NPU, many multinational pharmaceutical companies are actively planning company restructurings that include layoffs despite preserving their continuous sales growth in the COVID-19 crisis, and the domestic pharma-bio industry has also been going against the market growth and is deteriorating the working condition of its workers. Therefore, the NPU plans to actively engage in ongoing disputes of member unions while strongly responding to the restructuring that is expected in some companies. Deok-Hwan Ahn, Chairman of NPU, said, “We will work to set a standard for the wages and welfare of workers in the pharmaceutical and bio-industry and work in solidarity to respond to common issues that arise in the industry to guide the direction of our industrial union" The launch ceremony for the new industrial union will be held from 11:00 a.m. on July 5th, in the 6th-floor main conference room of the Federation of Korean Trade Unions Building. Meanwhile, many labor unions from Korean subsidiaries of multinational pharmaceutical companies that have left the Korea Democratic Pharmaceutical Union, the representative industrial labor union of multinational pharmaceutical companies, have joined NPU.
- Company
- 2nd P-CAB Fexclu to be released into the 800 bil market
- by Chon, Seung-Hyun Jun 30, 2022 05:52am
- Daewoong Pharmaceutical’s new drug, ‘Fexclu’ will be released next month. The industry’s eyes are on whether the drug will raise a storm in the PPI class and P-CAB class antiulcer medication prescription market that is estimated to be worth over ₩800 billion. The industry is also eyeing competition between Fexclu and K-CAB abroad. ◆Fexclu to be applied reimbursement from next month… prepares to target the ₩800 billion PPI·P-CAB market According to industry sources on the 29th, Daewoong Pharmaceutical’s Fexclu will be listed for NHI reimbursement starting next month. With the reimbursement approval, the drug will be released in the market 6 months after it received approval on December 30th. Fexclu’s insurance price cap was set at ₩939, which is 27.8% cheaper than its same-class drug K-CAB (₩1,300) Fexclu is a P-CAB class drug that treats gastroesophageal reflux disease (GERD). The drug was approved for the indication of treating erosive gastroesophageal reflux disease (GERD). P-CAB class antiulcer drugs competitively bind to the proton pump and potassium ion located in the final stage of acid secretion from the stomach wall to inhibit gastric acid secretion. This class of drugs has quickly settled in the market since HK inno.N introduced its first P-CAB type of new drug ‘K-CAB’ in 2018. Fexclu will be mainly targeting the PPI class and P-CAB class antiulcer drug market, which raised ₩842.1 billion in prescriptions last year. The PPI class market made ₩732.5 billion and the P-CAB class market ₩109.6 billion last year. The industry sees a high possibility of Fexclu’s success in the market. K-CAB had already demonstrated the marketability of P-CAB class anticancer drugs during the past 3 years. According to UBIST, K-CAB had raised ₩109.6 billion in outpatient prescriptions 3 years into its release last year, which is the first time a single brand of a homegrown novel drug had made annual prescriptions exceeding ₩100 billion. K-CAB had created a sensation selling ₩30.9 billion in the first year of its release and has continued its rapid growth in 2020 and last year. K-CAB’s sales continued to grow due to its advantages - having a faster onset of action than PPIs, is allowed to be taken regardless of meal ingestion, demonstrating superior symptom improvement, and showing longer-lasting night-time gastric acid suppression. With HCPs and patients in the field already showing high satisfaction with P-CAB class antiulcer medications using K-CAB, Fexclu is expected to make a relatively easier way into the market. Also, Fexclu’s insurance cap, which was set 30% lower than that of K-CAB may act as an advantage in the prescription market. However, K-CAB owns a total of 4 indications, rendering it difficult for Fesclu to completely replace K-CAB in the market. In addition to the treatment for erosive and non-erosive GERD, K-CAB sequentially secured additional indications as a combination therapy with an antibiotic for Helicobacter pylori eradication in patients with peptic ulcer or chronic atrophic gastritis. Among the indications, insurance reimbursement is applied to K-CAB for the treatment of GERD and stomach ulcers. Fexclu will also be targeting PPI-class drugs that account for the largest amount of the antiulcer drug market, as a significant amount of K-CAB prescriptions arise from patients who have switched to K-CAB from PPIs. Last year, the amount of outpatient prescriptions for PPI class drugs recorded ₩732.5 billion. This is a twofold increase in 5 years from the ₩372.4 billion in 2016 and is continuing to record high growth. ◆Fexclu·K-CAB accelerates entry to overseas market… competition in overseas performance of the two drugs also a point of interest The overseas market competition between Fexclu and K-CAB is also a point of interest. Daewoong Pharmaceuticals had signed 6 export agreements with 15 countries in North America, Latin America, China, Middle East to export Fexclu. In 2020, the company signed a contract with the Mexican pharmaceutical company Moksha8 and Brazil's EMS for the local marketing and sales rights of Fexclu and paved the way for Fexclu’s entry into Central and South America. In March last year, the company signed a $384.5 billion contract with China's Shanghai Haini Pharmaceutical. Status of Fexclu export agreements (Source: Daewoong Pharmaceutical)) In June last year, the company made a technology transfer agreement with U.S. company Neurogastrx and handed over the development, authorization, and sales rights of Fexclu in the US and Canada. Through the agreement, Daewoong Pharmaceutical secured a 5% stake in Neurogastrx as an upfront, non-refundable fee, and was assured up to $430 million in development, regulatory, and sales milestone payments. It then signed 2 additional export contracts to enter 10 countries in Central and South America and the Middle East. In total, Daewoong secured up to ₩1.2 trillion through export agreements for Fexclu. K-CAB has entered the market of a total of 34 countries through technology or finished product exports. HK Inno.N had first signed a technology export agreement with the Chinese company Shandong Luoxin Pharmaceutical in 2015. The deal was to receive $18.5 million in upfront payments and clinical development, regulatory, and sales milestone payments. The company estimated that the agreement amount would rise to $95.29 million with royalties incurred after the local commercialization of K-CAB. Also, HK InnoN signed an export agreement for the finished K-CAB product with the Mexican pharmaceutical company Laboratorios Carnot in February 2019 to export K-CAB to 17 countries in Central and South America. Its export amount, including supply price, has amounted to $84 million over the past decade. Exports agreements have been more actively made after K-CAB was released in Korea. In September 2019, contracts were signed to supply the finished drugs to Indonesia, Thailand, and the Philippines, and in 2020, export agreements were made to export K-CAB to Mongolia and Singapore. Last year, the company also signed export contracts with companies in Vietnam, Malaysia, the US, and Canada.
- Company
- Opdivo reattempts reimb in first-line gastric cancer
- by Eo, Yun-Ho Jun 29, 2022 05:54am
- The cancer immunotherapy drug Opdivo is reattempting reimbursement as a first-line treatment once more. According to industry sources, Ono Pharma Korea and BMS Korea’s PD-1 inhibiting cancer immunotherapy Opdivo (nivolumab) will be deliberated by the Cancer Disease Deliberation Committee (CDDC) of the Health Insurance Review and Assessment Service on the 28th. In Korea, Opdivo was approved ‘as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma’ in June last year. With the added indication, the drug became the first and only domestically approved cancer immunotherapy for the first-line treatment of gastric cancer. Also, Opdivo’s unresectable malignant pleural mesothelioma indication will also be deliberated at the CDDC meeting. More specifically, Opdivo’s indications as ▲ first-line treatment of advanced or metastatic gastric adenocarcinoma, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with chemotherapy, and ▲ in combination with ‘Yervoy’ in unresectable malignant pleural mesothelioma will be deliberated at the CDDC meeting. In the CDDC meeting that was previously held in February, the committee decided not to set reimbursement standards for both indications. Therefore, whether Opdivo’s second attempt at reimbursement in gastric cancer will bear fruit remains to be seen. Gastric cancer is considered to be the field in most urgent need of extended reimbursement to immunotherapy drugs after lung cancer. As the most prevalent cancer and the fourth most common cause of cancer deaths in Korea, gastric cancer has a favorable survival rate when detected in its early stages but its relative survival rate drops to 5.9% with distant metastasis. In particular, the current stand of care for HER2-negative gastric cancer is chemotherapy due to the unavailability of new drugs approved for first-line treatment for the past decade. Opdivo has received attention as a viable alternative for these patients. Meanwhile, Opdivo’s efficacy in lung cancer was confirmed through the large-scale Phase III CheckMate-649 trial. The median overall survival (mOS) of patients was 13.8 months for all patients randomly assigned to receive Opdivo compared to the 11.6 months in the control group. In PD-L1 positive patients (CPS ≥ 5), the Opdivo combination group’s mOS was 14.4 months, which was a 29% reduction in risk compared to the 11.1 months of the control group. Also, Opdivo improved the overall response rate (ORR) by 12% in the all-randomized population, and by 15% in PD-L1 positive patients (CPS ≥ 5). The complete response (CR) rate was also higher for the Opdivo combination group in both the all-randomized population and PD-L1 positive patients.
