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- 2025-12-24 12:16:18
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- Immunotherapy shows effect as first-line treatment for BTC
- by Dec 08, 2022 06:05am
- Biliary tract cancer has long remained an area in which no new drug has been developed. Following targeted therapies, immunotherapies have led to remarkable advances in anticancer treatment, but biliary tract cancer has been neglected in terms of developing new drugs. This is because it has a lower prevalence rate than other cancers like lung cancer or stomach cancer, and even lower incidence in the West, which has been leading the development of new drugs. In this area with minimal progress, AstraZeneca’s cancer immunotherapy Imfinzi obtained indication in Korea and abroad as a first-line treatment in biliary tract cancer. In Korea and abroad, Imfinzi became the first immunotherapy to be approved as a first-line treatment in biliary tract cancer, and this latecomer among immunotherapies beating its competitors like Keytruda and Opdivo and won the “first” title. One thing to note is that a Korean medical team led to Imfinzi’s global approval in biliary tract cancer. Professor Do-Youn Oh’s persuasion was what moved the pharmaceutical company to pursue this unattended area. At the European Society of Medical Oncology (ESMO) Asia Congress 2022 that had been held on the 2nd (local time) in Singapore, Professor Oh said, “I believe the biggest achievement that has been made is that Imfinzi’s first approval as a first-line treatment in biliary tract cancer opened the stage for other immunotherapies to take on research into the field of biliary tract cancer.” Professor Do-Youn Oh Around 10 years ago, Professor Oh proposed an investigator-led trial to pharmaceutical companies that own cancer immunotherapies after finding out that immunotherapies show relatively higher effects in biliary tract cancer. However, companies at the time were more focused on cancers that have many patients and showed little interest and a low understanding of biliary tract cancer itself. Oh recalled, “I proposed a clinical trial on biliary tract cancer to all companies that own cancer immunotherapies at the time. I offered to test the drug myself to AstraZeneca’s clinical team. The company accepted my offer, and so began the investigator-led Phase II clinical trial. The trial went well thanks to the AstraZeneca team's active engagement. Professor Oh and AstraZeneca designed a detailed and thorough clinical trial after long discussions. They added 2 cohorts and enrolled more subjects. Based on the anti-tumor effect and safety confirmed in Oh’s trial, a global Phase III trial was initiated, and Professor Oh took the role of principle investigator (PI) in the Phase III TOPAZ-1 trial. The TOPAZ-1 trial was a success. The Imfinzi arm (Imfinzi+ gemcitabine + cisplatin) showed a 20% improvement in overall survival (OS) versus the placebo arm (placebo+ gemcitabine + cisplatin). Further analysis showed a higher OS improvement of 24% in the Imfinzi arm. At 2 years, the 2-year survival rate in the Imfinzi arm was 23.6% compared with 11.5% in the placebo arm. Median PFS (mPFS) was 7.2 months for the Imfinzi arm, a 25% improvement over the 5.7 months shown in the placebo arm. Also, the Imfinzi arm achieved an objective response rate (ORR) of 26.7% (91 cases), 2.1% (7 cases) of which showed complete response, and 24.6% (84 cases) showed partial response. Based on Oh’s investigator-led trial and TOPAZ-1 results, the US FDA approved Imfinzi for the treatment of biliary tract cancer. Furthermore, the National Comprehensive Cancer Network recommended Imfinzi as the standard (Category 1) first-line treatment in biliary tract cancer. For the first time, a cancer immunotherapy drug was listed as a standard of care in a field that only had chemotherapy options. This was a very unusual case where a clinical trial initiated by a Korean healthcare professional led to global approval and a standard-of-care designation. Professor Do-Youn Oh is presenting her findings at the ESMO Asia Congress 2022 Even after the approval, Professor Oh is busy conducting further analysis on TOPAZ-1. At the ESMO Asia Congress, Oh presented results on the impact of mutation status on efficacy outcomes in the TOPAZ-1 trial. The result of the study, which was the first to analyze the effect of cancer immunotherapies according to mutation status, was that there was no significant difference in the effect of cancer immunotherapies depending on the presence or absence of major mutations. Professor Oh referred to the entry of Imfinzi in biliary tract cancer as a ‘starting point’ that opens the stage and drives the development of biliary tract cancer treatments. In other words, an area that has not been tried due to lack of knowledge and lack of interest has opened up for research. Oh said, “With the TOPAZ-1 study, people have come to recognize that immunotherapies can be developed for biliary tract cancer as well. With so many cancer immunotherapies of various mechanisms of action in development, the biggest significance held by the success of the TOPAZ-1 trial is that the stage has been set for these to be tested in biliary cancer as well.” Above all, Oh expressed pleasure in providing new hope for biliary tract cancer patients. Professor Oh said, “Polarization of treatment options exists in the field of cancer as well. Some cancers offer many treatment options, others less than few. Biliary tract cancer was one of those that had almost no available treatment options. Whenever my patients asked why they can’t use immunotherapies, all I could do was tell them that a research was underway. With an immunotherapy option now available for biliary tract cancer, I look forward to more progress being made in the field and various more studies to come.”
- Company
- Oral Exon20 targeted Exkivity to apply for reimb in Korea
- by Eo, Yun-Ho Dec 06, 2022 07:55pm
- The EGFR Exon20 insertion mutation targeted oral therapy ‘Exkivity’ is attempting reimbursement listing in Korea. According to industry sources, Takeda Pharmaceuticals Korea is preparing to apply for reimbursement of ‘Exkivity (mobocertinib), its treatment for non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. Although the drug targets the same biomarker as Janssen Korea’s ‘Ryvrevant (amivantamab),’ Exkivity is different as an oral formulation. EGFR Exon20 insertion mutation is a new biomarker that is newly receiving attention in the field of NSCLC. Targeted anticancer therapies that are currently available for prescriptions include those that target the Exon19 deletion or Exon21 L858R substitution mutations that are commonly found in EGFR mutations, but an unmet need had existed for EGFR Exon20 insertion mutations. Therefore, the industry’s eyes are on whether Exkivity will succeed in reimbursement listing with Ryvrevant failing to pass deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee. Meanwhile, Exkivity demonstrated its efficacy through a Phase I/II trial which enrolled 114 patients with EGFR Exon20 insertion-positive NSCLC who received prior platinum-based therapy. In the trial, patients who were treated with a 160 mg dose of Exkivity showed an objective response rate (ORR) of 28% as well as a median duration of response (DoR) of 17.5 months per independent review committee (IRC). In particular, the median time to response after Exkivity treatment was 1.9 months, demonstrating the rapid effect it shows from the beginning of treatment. The median progression-free survival (mPFS) was 7.3 months, and the median overall survival (mOS) 24.0 months. The safety profile was also manageable. The most common adverse reactions were diarrhea, rash, fatigue, etc, and were manageable through dosage adjustments.
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- ImmuneOncia targets niche market in cancer immunotherapy
- by Dec 06, 2022 05:57am
- “NK/T-cell lymphoma is a niche market that has no approved immunotherapy. After completing the trial in Q2 next year, we plan to promptly receive approval and extend our indication if we see good results.“ Heung Tae Kim, CEO of ImmuneOncia Therapeutics Inc On the 3rd (local time), Heung Tae Kim, CEO of ImmuneOncia Therapeutics, expressed his aspirations at the ‘ESMO Asia Congress 2022’ that was held in Singapore. ImmuneOncia is a new cancer immunotherapy drug-developing company that was established as a joint venture company between Yuhan Corp and the US bio-company Sorrento. The company owns various pipelines including the PD-L1 antibody IMC-001 and the CD47 antibody IMC-002, etc. The results that were presented were interim analysis results of a domestic Phase II trial that enrolled 13 patients with relapsed or refractory NK/T cell lymphoma who failed to see an effect with ‘L- asparaginase,’ the standard therapy. Professor Won-Seog Kim of the Hemato-Oncology Department at Samsung Medical Center presented the findings at the Mini Oral session on Haematological malignancies. Interim analysis efficacy results of Phase II IMC-001 trial (Source: ESMO Asia) Interim analysis results showed that of the 10 evaluable patients, 6 showed a response (ORR=60%), and all patients that showed a response had a complete response (CR=100%). 4 of the patients have continued treatment for at least 1 year. Based on the results, the evaluation was that the drug produced excellent results in terms of drug safety and continued response. The drug also was acceptable in terms of safety. No cytokine release syndrome hematologic toxicity that commonly arises with the use of immuno-oncology drugs was observed. Only 1 patient was observed with Grade 3 uveitis. During the clinical trial, 3 patients adjusted the medication period due to side effects, and 1 patient was delayed due to COVID-19 infection. The major adverse reactions were fatigue, headache, skin rash, and itching, most of which were mild and manageable. Interim analysis safety results of Phase II IMC-001 trial (Source: ESMO Asia) Professor Kim said, “Due to the small number of patients that were analyzed, we cannot conclude that IMC-001 is a far superior treatment, but I think it is at least similar or slightly superior (compared to existing immuno-oncology drugs). Although the survival period of recurrent patients is only 4-6 months, 4 out of 6 patients that responded to IMC-001 have survived long-term, receiving treatment for over a year. IMC-001 is a PD-L1 immunotherapy. Other drugs with the same mechanism of action include the global blockbuster ‘Keytruda (pembrolizumab)’ which sold over KRW 2.1 trillion and ‘Opdivo (nivolumab)’ which sold KRW 1 trillion globally. However, the two drugs do not indicate NK/T-cell lymphoma, the disease IMC-001 is being studied for. Professor Won-Seog Kim, Samsung Medical Center NK/T-cell lymphoma is a rare EBV-associated lymphoma. 90% of Asians are infected with the virus. Although an ordinary person would have no problem when infected, when immunocompromised, the dormant virus is activated and causes cancer. The current treatment option mainly consists of radiation and chemotherapy, but the 2-year recurrence rate is 75%. The company plans to start the approval process immediately after completing the clinical trial by Q2 next year and receiving the final data. ImmuneOncia will also actively promote the technical export of IMC-001 for its global entry. CEO Kim said, “We plan to first preoccupy the niche market through rapid domestic commercialization, then gradually expand its scope of indications. Also, we plan to promote technology exports to Asian regions including China, where many patients remain. We plan to reapply for the technical evaluation around Q3 next year."
- Company
- Concerns over Leclaza's sluggish secondary indicators
- by Dec 06, 2022 05:57am
- This is in contrast to the significant improvement in the primary indicator, the progression-free survival period (PFS). We cannot rule out the possibility that a similar situation to Tagrisso, whose effectiveness was questioned by the Asian OS, will be reproduced. The global clinical director (PI) explains that it is not easy to secure statistical significance due to the relatively high ratio of crossover converted to third-generation treatments due to confirmed resistance mutations among control patients. Cho Byung-chul, a professor of oncology at Yonsei Severance Hospital, who oversees LASER301 clinical trials, said at a press conference held in Singapore on the 3rd (local time), "Leclaza failed to meet the statistical significance of OS improvement because there was a high crossover rate of about 40 percent," adding, "There is no room for resistance change now." Professor Cho Byung-chul (left) and Professor Ross Su (right) explain the clinical results of phase 3 of Leclaza LASER301 is a global study that confirmed the effectiveness and safety of the first-generation treatment "Iressa" when Leclaza was used as the first treatment for EGFR-mutated non-small cell lung cancer patients. The first evaluation index was the progression-free survival period (PFS), and Leclaza recorded a 20.6-month PFS, which reduced the risk of disease progression and death by 55% compared to the control group, demonstrating high improvement. OS, the secondary indicator, has 29% data maturity, and sufficient data has not been collected. However, the survival rate of Leclaza at 18 months after administration was not statistically significant compared to the control group (p=0.116). At the time of 29% of data collection, 25% (49) of the Leclaza group died, and 32% (64) of the control group died. Looking at the trend of the graph of the total survival period released on this day, the survival rate of the Leclaza group and the control group becomes almost similar from 27 months after administration. The final OS data will be released at the end of next year. Leclaza phase 3 clinical overall survival graph (29% maturity). (Source: ESMO) Professor Cho explained that the high rate of crossover in the control group that received the first-generation treatment affected Leclaza's OS. Crossover refers to allowing patients classified as control groups to take other treatments at an ethical level if they do not see treatment effects due to resistance during the administration of control drugs. In phase 3 clinical trials, 24% (47) of 197 control groups changed the treatment to Leclaza through crossover. 12% (24) stopped clinical trials and administered other treatments. A total of 71 people (36%) stopped administering control drugs and switched to third-generation treatments. Tagrisso, the first 3rd generation EGFR formulation conducted earlier, was also affected by the OS by allowing crossover at the time of phase 3 clinical trials. Tagrisso Japan Real World Data The 40.9-month OS dispelled concerns caused by phase 3 data (Source: ESMO) Tagrisso demonstrated OS improvement over controls but failed to improve OS in Asian subgroups (HR=0.995). At that time, 85 (31%) of 277 patients in the clinical control group stopped administering first and second-generation treatments and received Tagrisso as a follow-up treatment, which caused "data bias." Because of this, Tagrisso's effectiveness was questioned by Asians. Concerns have been raised that Tagrisso's OS benefits are unclear in Asians. Tagrisso has also been pointed out as the main reason why it has not been listed on the domestic primary benefit so far. The effectiveness of Tagrisso is being proven in clinical practice. According to the recently released Real World data in Japan, Tagrisso recorded an OS of 40.9 months for more than three years. About 90% of EGFR-mutated non-small cell lung cancer patients in the United States and Europe as well as Japan are being treated with Tagrisso in the first round. Leclaza was also influenced by the clinical environment where the diagnosis of T790M mutations, the first and second generations of resistant mutations, became active. Professor Cho said, "At the time of phase 3 of Tagrisso, the T790M mutation itself was unfamiliar. Naturally, the diagnosis was not active. However, now, follow-up treatments have emerged and T790M tests are being actively conducted. Because of this, nearly 40% of patients were crossover. In other words, as resistance diagnosis was actively conducted, more patients were found to receive follow-up treatment. He added, "Leclaza's higher OS effect was observed when analyzed by applying the IPCW (Inverse Probability of Sensing Weight) technique." The IPCW technique refers to an analysis that minimizes "bias" by correcting crossover patient data. Professor Cho said, "I don't think the failure of OS to secure statistical significance will lead to concerns over the Leclaza effect." Ross A. Soo, a professor at the National Cancer Center in Singapore, also said, "It is still too early to evaluate OS, and the effectiveness of individual drugs can be confirmed by PFS indicators, and OS is an indicator of the entire treatment, including follow-up treatment."
- Company
- Rozlytrek can be prescribed at Big 5 hospitals
- by Eo, Yun-Ho Dec 06, 2022 05:57am
- Rozlytrek can be prescribed in big 5. According to related industries, Rozlytrek, a target anticancer drug for NTRK in Roche, Korea, passed the DC of Big 5, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, and Sinchon Severance Hospital. Bayer Korea's Vitrakvi has already entered the Big 5 hospitals, and both drugs have been covered by insurance benefits since April this month, so competition for full-fledged prescriptions has begun. The two drugs can actually be applied to most carcinomas where the NTRK gene has been identified. However, there are restrictions on standards. The subjects of salary administration of the two drugs were limited to cancer types mentioned in the NCCN guidelines. Rozlytrek, approved in Korea as a rare drug in April 2020, can be prescribed for solid cancer in adults and children aged 12 or older with NTRK gene fusion without acquisition-resistant mutations, and local progressive or metastatic non-small cell lung cancer, which is positive for ROS1 in adults. Rozlytrek's permission was determined based on clinical Phase 1/2 STARTRK-NG trials in pediatric patients and data from STARTRK-2, a major phase 2 clinical trial, and STARTRK-1 and ALKA-372-001 trials in clinical phase 1. In the STARTRK-2 study, Rozlytrek reduced tumors in more than half to 56.9% of patients with solid cancer positive for NTRK fusion genes. Patients were conducted on 10 different solid cancer patients, and the response duration was observed to be 10.4 months. At the International Conference of the World Lung Cancer Society in August, the results of an additional integrated analysis of Rozlytrek's major clinical studies conducted on patients were released. In this integrated analysis, Rozlytrek's objective response rate (ORR) was 67.4% in all patients, 63.3% in patients with cerebral metastasis, 69.6% in patients with non-brain metastasis, and 68.7% in patients with first-treatment. The progression-free survival (PFS) and overall survival (OS) were 16.8 months and 44.1 months, respectively, but there was no significant difference between the first-treatment patient group and the entire patient group.
- Company
- Leclaza P3T results unveiled... mPFS 20 months
- by Dec 02, 2022 06:07am
- The abstract data from a global Phase III trial on ‘Leclaza (lazertinib),’ the 31st homegrown novel drug developed by Yuhan Corp, has been released. In the trial, Leclaza improved progression-free survival (PFS) by 11 months compared to the existing treatment Iressa and met the primary endpoint. The study results of LASER301 above that assessed the safety and efficacy of Leclaza as first-line treatment in EGFR (epidermal growth factor receptor) mutant-positive NSCLC were released with other major study results on the 1st at the ESMO ASIA Congress 2022. LASER301 is a global Phase III trial that evaluated the efficacy and safety of Leclaza as first-line treatment in locally advanced or metastatic NSCLC patients with EGFR mutations. The trial enrolled 393 patients in 13 countries and compared Leclaza with the existing treatment, ‘gefitinib (brand name: Iressa).’ The primary efficacy endpoint was progression-free survival (PFS). The secondary endpoints were objective response rate (ORR), duration of response (DoR), disease control rate (DCR), and overall survival (OS). In terms of median PFS (mPFS), the primary efficacy endpoint, Leclaza’s mPFS was 20.6 months, a significant improvement over the 9.7 months in the control group. The drug also reduced the risk of disease progression and death by 55%. The PFS improvement was consistently observed in all predefined subgroups (Asians and non-Asians, Exon19del or L858R mutation, etc.). Leclaza’s DoR was 19.4 months, significantly longer than the 8.3 months in the control group. ORR was 76% in both treatment groups. The OS data has not matured yet (maturity 29%). At 18 months after administration, the lazertinib arm’s survival rate was 80%, higher than the 72% in the control group but did not reach statistical significance (p=0.116). Regarding its safety, lazertinib and Iressa showed a consistent safety profile with those that had been previously reported. The results of the LASER301 study will be presented at the ESMO ASIA Congress 2022 which will be held on the 3rd in Singapore. Leclaza is an NSCLC treatment that was approved as the 31st homegrown novel drug in January last year. It is a 3rd generation EGFR TKI that inhibits the proliferation and growth of lung cancer cells. It is currently approved as a second-line treatment for patients with locally advanced or metastatic NSCLC who developed resistance after being previously treated with 1st generation or 2nd generation EGFR-TKIs. Yuhan Corp conducted the global Phase III trial to expand the drug’s indication to first-line treatment in EGFR mutated lung cancer. The results greatly increased the possibility of the drug extending its indication to first-line in Korea. In Korea, Leclaza’s cumulative sales exceeded KRW 10 billion in only 1 year since its release with insurance reimbursement. If approved in the first line, its increase in sales is expected to accelerate further. Trials on its combined use with other drugs are also actively underway. Yuhan Corp had made a licensing deal with the global pharmaceutical company Janssen. Janssen has been developing the drug in combination with its own EGFR-MET bispecific antibody ‘Rybrevant (amivantamab).’
- Company
- Competition for chronic kidney disease following SGLT-2 I
- by Eo, Yun-Ho Dec 02, 2022 06:07am
- Competition for SGLT-2 inhibitors is expected to expand to the area of chronic kidney disease following heart failure. According to related industries, following AstraZeneca's Forxiga, Lilly and Beringer Ingelheim's Jardiance also succeeded in proving their effectiveness to secure chronic kidney disease indications. Forxiga is ahead in speed. After approval by the U.S. FDA in April, Forxiga immediately began the licensing process in major countries such as Korea and added chronic new disease indications in Korea and Europe in August. However, insurance benefits have not been applied so far. Forxiga's approval of chronic renal disease indication was based on phase 3 clinical DAPA-CKD study. Earlier this year, Forxiga was designated as a subject of the FDA-assigned Priority Review. According to the DAPA-CKD study, Forxiga reduced the relative risk of kidney failure compared to placebo, terminal kidney disease (ESKD), and death from cardiovascular or kidney by 39% in patients with stage 2-4 chronic kidney disease with increased UAE levels. ARR was 5.3% for 2.4 years, the median value of the study period. Jardiance recently announced the results of the EMPA-KIDNEY phase 3 at ASN's Kidney Week 2022. EMPA-KIDNEY was a study exclusively for a wide range of, large-scale SGLT-2 inhibitors, involving 6609 patients with various causes. Among them, many patients had cardiovascular, kidney, or metabolic-related comorbidities, and all kidney and cardiovascular results were evaluated according to the severity of various chronic kidney diseases. The previous SGLT-2 inhibitor study included the widest range of patients ever compared to a specific group with diabetes or high proteinuria among patients with chronic kidney disease. Looking at the study, Jardiance significantly reduced the risk of kidney disease progression or cardiovascular death by 28% compared to placebo. In addition, hospitalization due to all causes, one of the major complex secondary evaluation variables defined in advance, was significantly reduced by 14% compared to placebo. It was found that the results of hospitalization or cardiovascular death due to heart failure, a major secondary evaluation variable, or death reduction due to all causes were not statistically significant. Chronic kidney disease is a progressive disease, and it is investigated that up to 700 million patients around the world are distributed. Treatments that can be used in the patient group are limited, but it is necessary to enter new treatment options in that chronic kidney disease increases the incidence of cardiovascular events such as heart failure and affects early death.
- Company
- Balversa, the first targeted anticancer drug for bladder can
- by Dec 02, 2022 06:07am
- BalversaTargeted options targeting specific genetic mutations in bladder cancer have emerged for the first time. The Ministry of Food and Drug Safety announced on the 24th that it had approved Janssen's Balversa. It is an indication of metastatic urinary epithelial cancer (cystic cancer) with at least one type of chemotherapy treatment, or FGFR2 or 3 mutations within 12 months of adjuvant treatment before and after surgery, including platinum-based chemotherapy. Bladder cancer is representative cancer that had no targeted anticancer drugs. Balversa has become the first targeted anticancer drug for bladder cancer with a new mechanism called FGFR inhibition. FGFR is one of the bio-signals involved in cancer cell growth and is associated with several carcinomas. In particular, FGFR mutations are commonly observed in bladder cancer, and about 20 to 30% of patients are known to have mutations. The phase 2 BLC2001 study, which served as the basis for Balversa approval, targeted 99 patients with local progressive and metastatic urinary tract epithelial cancer with FGFR mutations. The ORR of 87 people who can be evaluated was 32.2% based on the IRRC evaluation. The disease control rate was 78% and the median response duration was 5.4 months. The progression-free survival (PFS) median and OS median were 5.5 months and 13.8 months, respectively. The most commonly reported adverse reactions of Grade 3 or higher include canker soreness, hand toenail dystrophy, hand toenail disorder, corneal inflammation, and hyperphosphatemia. Significant adverse reactions occurred in 41% of patients, of which eye disorders were reported by 10%. The adverse reactions that resulted in fatal results occurred in 1% of patients due to acute myocardial infarction. Based on the second phase, the Balversa permit was approved in April 2019, three years earlier than Korea in the U.S. To diagnose FGFR3 mutations, QuantiFERON's Therascreen FGFR Kit was also approved as a companion diagnostic device. ◆ A treatment for bladder cancer that has not existed for decades Bladder cancer is cancer that has been stagnant for decades. Unlike other cancers where several targeted anticancer drugs appeared, bladder cancer has been the main treatment until recently. The development of new drugs was not easy because of the high effectiveness of early chemotherapy. However, in metastatic bladder cancer, chemotherapy reacts in the early stages, and most of them die within two years due to resistance. The birth of the first targeted anticancer drug for bladder cancer Recently, immuno-cancer drugs have emerged, causing changes in the treatment of bladder cancer. There are four immuno-cancer drugs, including Keytruda, Opdivo, Tecentriq, and Bavencio, and there is a slight difference in specific indications. Keytruda and Tecentriq can be used as primary treatments. However, it can be used only when PD-L1 expression is positive and Cisplatin-based chemotherapy is impossible. Bavencio can be used as a maintenance therapy without the disease progressing after using chemotherapy in the first round. Opdivo is used as a secondary treatment when the disease progresses after chemotherapy. Keytruda and Tecentriq can also be used in the second round. Immuno-cancer drugs have a high response rate of around 20%, but they have fewer side effects than chemotherapy and have the advantage of maintaining treatment responses for a long time. With Balversa's permission, patients with FGFR mutations can consider targeted anticancer drugs in secondary or higher treatment, which is expected to help improve their prognosis.
- Company
- Ajovy will it be possible to register this year?
- by Eo, Yun-Ho Dec 01, 2022 05:46am
- Attention is focusing on whether the second CGRP target migraine drug Ajovy will be able to apply for insurance benefits within this year. According to related industries, Teva Handok is conducting last-minute coordination in drug price negotiations between the NHIS and the Calcitonin gene-related peptide (CGRP) target migraine treatment Ajovy. Considering that the benefit of Emgality in September, a competitive drug and the first entry item, has been applied, the negotiations have been delayed more than expected. Currently, there is no big disagreement with the calculation of drug prices itself, but factors such as the expected amount of claims are known to be an obstacle. Considering the negotiation date, if it goes according to the procedure, it is possible to register within this year, so we have to watch Ajovy's progress. If Ajovy succeeds in registering, competition between the two drugs is expected to begin in earnest. Emgality and Ajovy are the same drugs, and they are selected according to the characteristics of severe migraine patients. Emgality is a method of administering 240 mg (two consecutive subcutaneous injections each of 120 mg) once at a loading dose, and then subcutaneous injections of 120 mg once a month. Ajovy is used by subcutaneous injection of 225 mg once a month or 675 mg (three consecutive times of 225 mg) once every three months. Ajovy proved its effectiveness through a 12-week HALO EM/CM clinical trial in 2,000 patients with EM and CM. In a HALOEM study conducted to verify the efficacy and safety of Ajovy compared to the placebo group, Ajovy was evaluated to meet the primary evaluation variable by significantly reducing the number of monthly migraine occurrences in both monthly and quarterly administration groups. The proportion of patients whose average monthly migraine days decreased by more than 50% was also higher at 47.7% in the Ajovy monthly administration group and 44.4% in the quarterly administration group compared to 27.9% in the placebo group. In the HALOCM study, the average number of monthly headache reduction days in the Ajovy administration group was 4.6±0.3 days, and the quarterly administration group was 4.3±03 days, showing a significant decrease compared to 2.5±0.3 days in the placebo group.
- Company
- Expansion of Roche Polivy's indication of primary therapy
- by Eo, Yun-Ho Dec 01, 2022 05:46am
- From the Ministry of Food and Drug Safety, Roche Korea announced on the 28th that Polivy and Rituximab+Cyclophosphamide, Doxorubicin, and Prednisone combination therapy has been approved to expand the indication as the primary treatment for adult patients with diffuse large B-Cell Lymphoma whose have no previous treatment experience. Diffuse large B-Cell Lymphoma is a blood cancer with aggressive tendencies and is the most common form of non-Hodgkin lymphoma. In Korea, it is estimated that the number of new patients diagnosed with diffuse giant B cell lymphoma reaches 5,000 every year. Although the majority of patients responded to initial treatment, 4 out of 10 patients were not treated with the current standard treatment, and there was a demand for more effective primary treatments due to poor prognosis when the number of treatments increased. The permission to expand the indication was based on the results of the POLARIX study in phase 3 clinical trials. The study was followed for more than 24 months for all patients, and in the first-line treatment of diffuse giant B cell lymphoma during a 28.2 month follow-up period, Polivy, and R-CHHP combination therapy reduced the likelihood of disease exacerbation or death by 27% compared to R-CHOP. The most frequently reported adverse reactions during Polivy treatment (30% or more) were peripheral neuropathy (52.9%), nausea (41.6%), neutrophil reduction (38.4%), and diarrhea (30.8%). Nic Horridge, CEO of Roche Korea, said, "We have continued to innovate to meet the unmet demand of patients, and finally we can provide improved treatments to Korean patients. Through Polivy, the expansion of this indication can provide better results for more patients with diffuse giant B-cell lymphoma."
