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- 2026-03-17 16:20:01
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- Changes in sales and marketing of companies
- by Moon, sung-ho Feb 15, 2022 05:53am
- As the COVID-19 pandemic continues for more than three years, changes are also taking place in academic sales and marketing of pharmaceutical companies. Pharmaceutical companies are competitively holding events for doctors on a rich theme and scale comparable to academic conferences of medical associations. This is a self-rescue measure due to the decrease in promotional activities, such as the prolonged COVID-19 and the transition of academic conferences to online conferences. According to the medical and pharmaceutical industries on the 10th, it was confirmed that more and more domestic pharmaceutical companies are holding large-scale "online symposiums" reminiscent of major medical conferences. The first case of introducing this is Dong-A ST's Korea Disease Week (KDW). It looks like an academic conference held by major domestic academic societies, but it is an online symposium held by Dong-A ST itself. In terms of size, it is as good as the academic conferences of existing academic societies. The period lasted for a week, and in addition to existing chronic diseases such as high blood pressure and diabetes, various experts related to cardiovascular disease were invited to form a large-scale academic feast, which received great response last year. When the KDW was held last year, an average of 2,100 doctors per day and a total of 10,500 doctors participated in the event. It is said that it was much more than the number of people participating in the general academic conference event. Dong-A ST is pushing for its second hosting in June. Domestic pharmaceutical companies such as Daewoong Pharmaceutical and Daewon Pharmaceutical are also competitively striving to hold online symposiums for their own doctors. In the case of Daewon Pharmaceutical, an academic event was held under the name AGORA WEEK in a similar way to Dong-A ST's KDW, while Daewoong Pharmaceutical also decided to hold an academic event for doctors under the name of Dowong Medical Festival (DMF). Another common point is that they are trying to expand the area of "online platform" for their doctors by holding such large-scale academic events. In particular, Daewon Pharmaceutical has a strong purpose of promoting the operation of an online platform (D·Talks, Detox) for doctors earlier this year. Likewise, Mediflicks and Doctorville use their own operating online platforms in common. At the same time as the academic symposium is held, the video is provided so that doctors can check it at any time by using the platform themselves.
- Company
- The era of personalized healthcare has arrived
- by Eo, Yun-Ho Feb 14, 2022 05:54am
- Optimal treatment for each patient differs by one’s genetic mutation. With this discovery, anticancer therapies targeting individualized genes have emerged one after another, and the field of precision medicine is evolving from ‘disease-targeted’ to ‘gene-targeted’ prescriptions. In particular, anticipation in the field is rising with the nearing possibility of prescribing NTRK(Neurotrophic tyrosine receptor kinase) inhibitors and the introduction of RET-targeted therapies in Korea. ◆'Rozlytrek ' and 'Vitrakvi' Roche Korea’s 'Rozlytrek (entrectinib)’ and Bayer Korea’s ‘Vitrakvi (Larotrectinib)’ are undergoing processes to receive insurance benefits in Korea. These two drugs, which are aiming to receive reimbursement through the pharmacoeconomic evaluation exemption track, have passed deliberations by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee last year but are yet to reach an agreement with the NHIS in their drug pricing negotiations. The drugs are indicated for the treatment of adult and pediatric patients who have an NTRK gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; have either progressed following treatment or have no satisfactory alternative therapy. In other words, the drugs may be used in most NTRK gene fusion-positive solid tumors. Roche and Bayer are generating prescription codes for their drugs at major medical institutions to allow the drugs to be prescribed immediately upon reimbursement. ◆'Gavreto' and 'Retevmo' Rozlytrek’s developer Roche is also undergoing the approval process for its other tumor-agnostic therapy 'Gavreto (pralsetinib),’ and Lilly Korea for its 'Retevmo (selpercatinib).’ The two drugs are expected to be approved within the year. The drugs, which target RET(Rearranged during transfection) gene fusions, inhibit the primary as well as the secondary mutation that causes resistance to anticancer treatments and are expected to address the unmet needs in various cancers. Retevmo, which had been quicker, became the first-ever RET inhibitor to receive approval. Retevmo was approved in May 2020, and Gavreto in September of the same year by the US FDA. Retevmo was approved for the two indications of non-small cell lung cancer (NSCLC) and thyroid cancer. Gavreto was initially approved as a treatment for lung cancer, then added a thyroid cancer indication in December of the same year. Although the drugs were initially approved for lung cancer and thyroid cancer, the companies plan to further increase the scope of indications for their RET inhibitors. RET gene fusion is discovered rarely in colorectal cancer, breast cancer, pancreatic cancer, and EGFR-mutant NSCLC. Gavreto and Retevmo are also expected to take the PE exemption track to receive reimbursement listing in Korea. Kyong-Hwa Park, Professor of Hemato-Oncology at Korea University Anam Hospital said, “There needs to be a reimbursement track established for precision medicine in Korea. I can’t imagine the distress and deprivation the patients would feel if a precision medicine drug is available with NGS screening but cannot be accessed due to systemic issues."
- Company
- Saxenda is also effective for childhood obesity
- by Feb 14, 2022 05:54am
- Saxenda of Novonodisc, a drug that can be used in children and adolescents, has emerged as an option for the first time. Effective weight loss is expected to help treat obesity in children and adolescents, but the fact that there is little data on Koreans should be supplemented. Novonodisc held a " Saxenda expansion of Pediatric Adaptation Meeting" at the Shilla Hotel in Jung-gu, Seoul on the 10th and pointed out the meaning of treating obesity in children and adolescents. Saxenda (Liraglutide), a GLP-1 analog, obtained an indication for pediatric and adolescent administration from the MFDS in December last year. The targets are children and adolescents aged 12 or older who are obese with an initial body mass index (BMI) of 30 kg/㎡ or higher in adults and weigh more than 60 kg. In SCALE TEENS clinical trials conducted for 56 weeks on 251 obese children and adolescents worldwide, Saxenda showed a significant weight loss effect. 74% of the Saxenda-administered group showed weight loss (28% of the placebo group), and the proportion of pediatric and adolescent patients who lost weight by more than 5% was 43%, significantly higher than that of placebo countries. The proportion of patients with weight loss exceeding 10% was 26% (8% of placebo group). At week 56 after discontinuation of the drug, the Saxenda group gained some weight, but nevertheless maintained a significant difference from the placebo group. Professor Lee Young-joon of Pediatrics and Adolescents at Korea University Ansan Hospital (General Director of the Korean Pediatric Endocrine Society), who was in charge of the presentation, commented that Saxenda will be able to help effectively lose weight at a time when childhood obesity increases. This is because so far, the drug treatments available to children and adolescents have been limited. Unlike adults, children and adolescents could only use Xenical, Metformin or Phentermine for a short period of time for those over the age of 16. Professor Lee said, "In the case of children and adolescents, parallel therapy with drug treatment is considered if it does not improve even with the improvement of primary lifestyle improvement is considered. Surgery is strictly restricted, he said. "I think Saxenda can be used as a breakthrough treatment option because it guarantees a relatively safe 5% weight loss effect." Saxenda has the disadvantage of including only two Asians in clinical trials that served as the basis for approval as a treatment for obesity in children and adolescents. Considering that there are differences within BMI from race to race, it is questionable whether it can have the same effect in Koreans. Professor Lee also said, "Only two Asians were included. Research on new drugs in children and adolescents is limited. Previously, other drugs tried clinical trials for children and adolescents, but they were suspended because they were not recruited, he explained. He then advised, "We need to build up Real World Data while carefully using Saxenda in Korea."
- Company
- Successful renewal of RSA contract for Keytruda
- by Eo, Yun-Ho Feb 11, 2022 05:56am
- Keytruda, an immuno-cancer drug, succeeded in renewing its RSA contract for the first time in half a year. According to related industries, MSD Korea signed an RSA renewal with the NHIS last month for indications such as NSCLC therapy, which is currently covered by PD-1 low-release Keytruda. Keytruda, which contract expired in August last year, recently passed HIRA's Drug Reimbursement Evaluation Committee, coupled with the expansion of benefits for indications such as primary therapy for non-small cell lung cancer. As a result, Keytruda will remain covered for five years. If the benefit is successful, the corresponding indication will also be added. Meanwhile, Keytruda has been challenging the government for about five years to receive primary lung cancer therapy benefits. It passed the committee on the 13th of last month, and finally negotiated with the NHIS. Keytruda, released in 2015, is an Immune Checkpoint Inhibitor that inhibits "PD-1" protein on the surface of immune cell T cells to block binding with PD-L1 receptors and treats cancer through activation of immune cells. In Korea, 18 indications for Keytruda were approved for 14 carcinomas, including melanoma, lung cancer, and head and neck cancer. Keytruda's quarterly sales remained around 3 billion won immediately after its release, but sales have risen since August 2017 when insurance benefits were applied as a secondary treatment for non-small cell lung cancer. Sales are likely to surpass 200 billion won last year. Keytruda also posted $12.6 billion (15 trillion won) in cumulative sales in the third quarter of this year in the global market.
- Company
- Prodrug for Forxiga patent dispute ruling has been postponed
- by Kim, Jin-Gu Feb 11, 2022 05:55am
- Forxiga The second trial ruling on the patent dispute between Dong-A ST and AstraZeneca over Forxiga, a diabetes treatment based on SGLT-2 inhibitors, has been postponed. The Patent Court's 5-2 Court postponed the date of the judgment on the trial decision cancellation suit filed by AstraZeneca against Dong-A ST from the 10th to the 17th. The court seems to have been worried in that it was the first case in Korea to try to overcome material patents using a "prodrug" strategy. Prodrug is evaluated as a different drug, such as an original drug. The original drug and chemical structure differ in some parts of the substituent until immediately before taking it after the drug is produced. However, when a patient enters the body after taking it, it has the same effect as the original drug. In terms of principle alone, it is similar to salt change, but the difference is clear. The salt can be converted into a simple ionic bond. The chemical structure of the substance itself does not change. Prodrug has to change the substituent in a more demanding way called covalent bonds. The chemical structure is different from the original drug. In this regard, the Intellectual Property Trial and Appeal Board (first trial) interpreted prodrug as a new drug different from the original drug and sided with Dong-A ST. The pharmaceutical industry believes that if Dong-A ST wins the second trial following the first trial, the prodrug strategy will be a new breakthrough in overcoming material patents. It is predicted that another attempt will be made to overcome material patents through prodrucg development. Attention is also being paid to whether Dong-A ST will be able to release generic for Forxiga alone. Other generics in Korea can launch after April 2023, when the Forxiga material license ends. Dong-A ST has applied for permission for Forxiga's Prodrug last month. If Dong-A ST wins by the second trial following the first trial, it is predicted that it will enjoy the effect of preoccupying the market in for Forxiga's generic market. Dong-A ST has its own DPP-4 inhibitor-based diabetes treatment, Suganon and Sugamet. Securing SGLT-2-based drugs with Forxiga's Prodrug is expected to create considerable synergy in the diabetes treatment market. According to UBIST, a pharmaceutical market research firm, Suganon and Sugamet's outpatient prescriptions amounted to 32.6 billion won last year. Forxiga posted 42.6 billion won in prescription last year.
- Company
- Skyrizi adds psoriatic arthritis indication
- by Feb 10, 2022 05:54am
- Pic of Skyrizi Abbvie’s ‘Skyrizi’ has expanded its indication to psoriatic arthritis. As the fourth interleukin inhibitor to receive approval for the indication, Skyrizi has set out to overtake the market with its convenience in administration. On the 9th, Abbvie Korea has held a ‘Press Conference to celebrate Skyrizi’s indication expansion to psoriatic arthritis’ online. Skyrizi, which was first approved for moderate-to-severe plaque psoriasis in 2019, added the psoriatic arthritis indication on the 5th of last month. Skyrizi may be used to treat adult patients with active psoriatic arthritis who had responded inadequately or were intolerant to disease-modifying anti-rheumatic drugs (DMARDs). Professor Young-Beom Choi of the Department of Dermatology at Konkuk University Hospital said, “Biologic drugs tend to lose their effect with long-term administration due to tolerance issues and need to be replaced with other drugs. Therefore, we doctors are pleased that a new treatment option has been introduced to the area. Skyrizi has provided new treatment opportunities to patients with its improved convenience in administration.” Young-Beom Choi, Professor of Dermatology at Konkuk University Hospital Psoriatic arthritis, which is related to psoriasis, develops in various forms such as peripheral arthritis, dactylitis (inflammation of the fingers and toes), skin psoriasis, and enteritis. It affects all joints but is especially common in smaller joints such as the hands and feet. Around 10% to 15% of patients who develop psoriasis progress to psoriatic arthritis in 4 to 5 years. Skyrizi’s efficacy in psoriatic arthritis was demonstrated in the two Phase III KEEPsAKE-1and KEEPsAKE-2 trials. The drug showed a significant effect compared to placebo in the primary endpoint of ACR20 (20% improvement in joint symptoms) at week 24. In the two studies, 57% and 51% of patients receiving Skyrizi achieved the primary endpoint of ACR20 response at week 24, respectively, compared to the 34% and 27% receiving placebo. Also, the patients’ presence of enthesitis and dactylitis had improved by 24 weeks and the effect was maintained until week 52. Skyrizi was late to receive approval for the psoriatic arthritis indication than Tremfya, another drug that has the same mechanism of action. Tremfya received approval for the psoriatic arthritis indication in April last year and became the 3rd interleukin inhibitor to receive approval for the indication. Other interleukin inhibitors that had been previously used are the IL-17 inhibitor ‘Cosentyx’ and ‘Taltz.’ Late in entering the market, Skyrizi is attempting to expand its market share with its differentiated advantage, its less frequent administration regimen. Professor Choi also pointed to the dosing schedule as Skyrizi’s most prominent feature. Skyrizi is administered the least in a year among all IL-17 and IL-23 inhibitors. Contrary to IL-17 inhibitors that are administered every 4 weeks, 12 times a year, Skyrizi is administered every 12 weeks, 4 times a year. Professor Choi said, “Younger adults who work have difficulty visiting hospitals every month. Patients prefer Skyrizi because they only need to visit once every three months. In addition to comorbidities and symptoms, patient preference is also an important factor considered when selecting drugs.” In addition to psoriasis and psoriatic arthritis, Abbvie plans to expand the reach of Skyrizi further to various autoimmune diseases. Seok-Yui Kim, Director of Medical at AbbVie said, “Global Phase 3 trials for Skyrizi are ongoing in Crohn's disease, ulcerative colitis, and the rare autoimmune disease hidradenitis suppurativa.”
- Company
- SK Bioscience releases second batch of COVID-19 vaccines
- by Kim, Jin-Gu Feb 10, 2022 05:54am
- SK Bioscience announced that it had shipped its second batch of commercial COVID-19 vaccine products. By manufacturing vaccines for AstraZeneca and then Novavax, the industry's evaluation is that the company has well demonstrated its large-scale and stable manufacturing capacity. SK Bioscience announced that it had shipped the first batch of Nuvaxovid from its L House in Andong, North Gyeongsang Province in the morning of the 9th. The released batch is predicted to be 840,000 doses of the vaccine that was approved for lot release by the Ministry of Food and Drug Safety the day before. SK Bioscience plans to ship out 2 million doses by the end of this month. Also, the manufacturing amount is expected to further increase from next month. SK Bioscience had signed an agreement with the government to supply 40 million doses of Nuvaxovid within this year. This is twice the amount of AstraZeneca’s vaccines that were supplied by the company to Korea last year. Last year, AstraZeneca signed a CMO deal with SK Bioscience to supply 20 million doses of its vaccine. SK Bioscience is known to have supplied 9,998,300 doses of AstraZeneca’s vaccine just in August last year, demonstrating its ability to manufacture and supply up to 10 million doses a month. SK Bioscience is considered to have well demonstrated its large-scale vaccine production capacity with its verified commercial batches of AstraZeneca and Novavax vaccines. Biologic agents, including vaccines, require quality verification by the MFDS every time a batch is produced for commercialization. According to SK Bioscience, its L House can manufacture up to 560,000 doses of vaccines per day. Multiplying the capacity by 252 working days, the maximum manufacturing capacity of the plant can be estimated to be around 141.12 million doses. By Q3 of last year, SK Bioscience had manufactured 43.25 million doses of vaccines, including AstraZeneca’s vaccines. In only 3 quarters, the company had manufactured four times the 11.48 million doses it had manufactured during the previous year. By the end of last year, the company had manufactured over 60 million doses. Based on the company’s stable manufacturing capacity, SK Bioscience anticipates it will be able to produce its own COVID-19 vaccine ‘GBP510’ in development without any problem even if it is approved in the first half of this year Currently, 9 lines are in operation in the L House. Excluding the one line used to preserve vaccine solutions (cell bank), a total of 8 lines are being used for the actual manufacturing of vaccines. 3 of the lines produce finished Nuvaxovid vaccine products for domestic supply. 2 of the other 5 lines produce vaccine solutions for separate supply to Novavax. The remaining 3 lines produce chickenpox, shingles, and pneumococcal vaccines. If GBP510 is approved in the first half of the year and starts being supplied in earnest in Korea, the company may switch a few of the chickenpox, shingles, and pneumococcal vaccine manufacturing lines for its manufacture. SK Bioscience plans to further expand its production capacity in the long term. The company plans to expand its manufacturing facility in two phases. First, the company has secured a new site near L House to establish additional manufacturing facilities for finished products such as pre-filled syringes and liquid vials by 2024. Also, the company set a goal of adding 12 animal cell incubators of a 2,000-liter scale and two microbiological incubators of a 1,000-liter scale at the same time. As the second step, the company plans to additionally secure manufacturing facilities for raw and finished products to triple its capacity by 2026.
- Company
- Effect of the release of generics for Tamsulosin
- by Ji Yong Jun Feb 10, 2022 05:54am
- The size of the Tamsulosin market, a treatment for prostatic hypertrophy, has soared. The market is also expanding as the influence of generic products has increased since the patent expired in 2015. According to UBIST, a pharmaceutical market research firm, on the 5th, Tamsulosin's outpatient prescription amount last year was 191.2 billion won, an increase of 5% from the previous year. The Tomsrosine market, which was worth 136.9 billion won in 2017, grew 40% in four years. Tamsulosin is α blocker that selectively act on bladder and prostate receptors to lower side effects. It is an ingredient prescribed for prostate hypertrophy patients. As prostate hypertrophy is an senile disease, the number of patients is also increasing recently. According to The HIRA, the number of patients treated for prostate hypertrophy in 2020 was 1.34,329, an increase of 9.4% from 2017 (1191,1595). Tamsulosin is analyzed to have expanded the market in line with the increase in prostate hypertrophy patients and the generic offensive. After the expiration of the original Harunaldi's patent in 2015, generics began to enter the market one after another. As of last year, 87 companies are competing in the Tomsrosine market, as the number of companies entering the generic market has steadily increased. Generics are increasingly influential in the Tamsulosin market. Last year, the amount of outpatient prescriptions for Tomslosin was 116.7 billion won, up 14% from the previous year. Tomslosin, which was worth 63.7 billion won in 2017, increased 83% in four years to 116.7 billion won in 2021. Generic's market share also jumped 14.5% points from 46.5% to 61% during the same period. Among the generics, Hanmi Tams of Hanmi Pharmaceutical and Hanmi Tams OD stood out. The amount of joint prescriptions for the two items last year was 31.7 billion won, up 16.1% from the previous year. Compared to four years ago, it surged 174%. It increased 27.6% from 11.6 billion won in 2017 to 14.8 billion won in 2018, and continued to grow to 19.8 billion won in 2019 and 27.3 billion won in 2020. Industry people say that the introduction of higher capacity than the original was the main reason why Hanmi Tams and Hanmi Tams OD were able to grow. Among generics, Genuonescience's Taminal amounted to 7 billion won, up 3.9% from the previous year. In addition, Dongkoo's Uropa, Kyung Dong's Uronal, Daewoong Bio's Bearosin, and Celltrion 's Tamsol raised more than 4 billion won in outpatient prescriptions. Sales of the original Harnal-D of Astellas are slowing down a little due to the release of generics. Last year, sales of Harnal-D amounted to 74.5 billion won, down 6% from a year earlier. Compared to the amount of outpatient prescriptions in 2017, it increased by 2%. Harnal-D increased 10.8% over the past two years from 73.2 billion won in 2017 to 81.1 billion won in 2019. However, in 2020, the following year, it fell 1.9% from the previous year to 79.6 billion won, and the decline continued last year.
- Company
- Sales in the PPI market are↑ 60% over the past 3 years
- by Kim, Jin-Gu Feb 10, 2022 05:53am
- The PPI anti- ulcer drug market has changed rapidly since the Ranitidine crisis. The market expanded sharply shortly after Ranitidine crisis, but growth has slowed down in the past year. Esomeprazole, Rabeprazole, and Ilaprazole enjoyed the reflective effect of Ranitidine crisis. On the other hand, in the case of Lansoprazole and Pantoprazole, it was difficult to expand their influence on the Ranitidine situation. ◆PPI market grows 61% compared to just before Ranitidine crisis According to UBIST, a pharmaceutical market research firm on the 4th, the amount of outpatient prescriptions for PPI-based anti- ulcer drugs last year was 732.5 billion won. Compared to 454.9 billion won in 2018, it increased by 61% in three years. PPI-based anti- ulcer drugs are the treatments that treat peptic ulcers and gastroesophageal reflux diseases by blocking proton pumps, the final stage of gastric acid secretion, and maintaining a high hydrogen ion index (pH) in the stomach. The reason for the rapid expansion of the market is the Ranitidine incident that occurred in 2019. In June 2019, impurities were detected in Ranitidine, an H2 receptor antagonist-based anti- ulcer drug. Eventually, the sale of this drug was stopped. When Ranitidine, the most commonly used in the market, was removed from the market, and PPI-based drugs enjoyed reflective effects. The annual prescription performance of PPI drugs by year increased to around 10% every year until 2018. In 2019, when the Ranitidine crisis occurred, the increase increased by 18% year-on-year. Then, in 2020, when Ranitidine was completely removed from the market, it increased 24% year-on-year. However, the growth trend that has continued since Ranitidine crisis last year seems to have slowed somewhat. The prescription amount of PPI-based drugs increased by 10% to 732.5 billion won last year. Some analysts say that the rapid growth of K-cab, a new P-CAB anti- ulcer drug, and the prolonged COVID-19 crisis have played a combined role. HK inno.N's K-Cab has posted 30.9 billion won in prescription performance that year since its release in March 2019. In 2020, it more than doubled to 76.1 billion won. Last year, it recorded 109.6 billion won, exceeding 100 billion won in prescriptions in the third year of its launch. ◆Esomeprazole·Ilaprazole vs Lansoprazole·Pantoprazole Esomeprazole, Ilaprazole, and Rabeprazole greatly expanded their influence after Ranitidine crisis. The drug that enjoyed the greatest reflective effect is Esomeprazole. Esomeprazole posted 319.4 billion won in prescription last year. Compared to 19.8 billion won in 2018, before Ranitidine crisis, it increased 63%. In the case of Rabeprazole, it increased 34% from 125.9 billion won to 169.1 billion won during the same period. Ilaprazole increased 33% from 28.3 billion won to 37.6 billion won. In the case of Lansoprazole and Pantoprazole, it is analyzed that they did not enjoy the reflective effect properly despite the gap of Ranitidine. Lansoprazole's prescription amount increased only 4% from 49.1 billion won in 2018 to 51 billion won last year. Pantoprazole increased 4% from 34.7 billion won to 36.3 billion won during the same period. Last year, both ingredients showed a decrease in prescription performance compared to the previous year.
- Company
- Opdivo to be deliberated by CDDC for stomach cancer indicati
- by Eo, Yun-Ho Feb 09, 2022 06:10am
- Whether a reimbursed treatment option would become available in the field of gastric cancer is receiving attention. According to industry sources, Ono and BMS’s PD-1 inhibitor immuno-oncology drug ‘Opdivo (nivolumab)’ will be deliberated by the National Health Insurance Service’s Cancer Disease Deliberation Committee on the 23rd of this month. In June last year, the Ministry of Food and Drug Safety approved an additional indication for Opdivo as ‘first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for patients with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction or esophageal adenocarcinoma.’ With the approval, Opdivo became the first and only immunotherapy to be approved in Korea as first-line treatment for gastric cancer. Gastric cancer is considered to be the most important area in need of extended reimbursement for immunotherapy drugs after lung cancer. Gastric cancer is the most prevalent cancer and the fourth most common cause of cancer deaths in Korea. Although gastric cancer has a favorable survival rate when detected in its early stages, its relative survival rate drops to 5.9% with distant metastasis. The current standard of care for HER2-negative gastric cancer has been chemotherapy for the past decade due to the unavailability of new drugs approved for its first-line treatment. Opdivo is expected to become a suitable alternative for these patients. Meanwhile, the efficacy of the combination therapy using Opdivo was demonstrated in 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 the Opdivo combination compared to the 11.6 months in the control group. Among PD-L1 positive patients (CPS ≥ 5), mOS of the group receiving the Opdivo combination was 14.4 months, 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.
