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- 2025-12-25 04:43:00
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- Expanded indication for Jardiance
- by jung, sae-im May 29, 2022 05:15pm
- The SGLT-2 inhibitor Jardiance expanded the indication to HFpEF. Beringer Ingelheim Korea and Lilly Korea announced on the 26th that Jardiance has been approved by the MFDS to expand its indication as a treatment for chronic heart failure regardless of left ventricular contraction function (hereinafter referred to as heart rate). Jardiance was approved by HFrEF last November. It is expanded by preserving the cardiac output rate, and it can be used to treat patients with chronic heart failure regardless of the cardiac output rate. Heart failure is divided into reduction, vigilance, and preservation according to heart rate. The ejection rate is reduced by less than 40%, the boundary is 40 to 50%, and more than 50% is considered conservation. There have been no drugs that encompass both reduction and preservation of the ejection rate. Jardiance has become the first and only drug in Korea. The number of heart failure patients in Korea is about 1 million, accounting for about 50% of all heart failure patients with HFpEF. Heart failure with preserved heart rate has a high prevalence rate and patients' prognosis is not good, but there have been no clinically effective treatments. Jardiance demonstrated efficacy and safety in phase 3 clinical studies of EMPEROR-Preserved in patients with cardiac output retention heart failure (HFpEF). Clinical results in 5,988 heart failure patients showed that Jardiance reduced the relative risk of hospitalization due to cardiovascular death or heart failure, a primary evaluation variable, in adult chronic heart failure patients with preserved heart rate, regardless of diabetes. Second-order evaluation variable analysis not only reduced the relative risk of first and re-admission due to heart failure by 27%, but also delayed the reduction of glomerular filtration rate (eGFR), an indicator of renal dysfunction. Jardiance's overall safety profile was consistent with previous clinical trial results. The standard for administration of patients with renal impairment in type 2 diabetes was also eased. Previously, patients with type 2 diabetes with eGFR of less than 60 ml/min/1.73 m could not start treatment with Jardiance. With this change, patients with eGFR 45ml/min/1.73m can also start treatment with Jardiance. In patients with renal impairment with chronic heart failure, Jardiance can be used if the eGFR is 20ml/min/1.73m or higher. This was set in the same way as the standard for patients with heart failure with reduced cardiac output, whose indications were approved in November.
- Company
- Lorviqua, which is about to be reimbursed, has settled
- by Eo, Yun-Ho May 29, 2022 05:15pm
- The third-generation ALK inhibitor Lorviqua has settled in the Big Five Hospital. According to related industries, Lorviqua of Pfizer Korea passed the Drug Committee of Big 5 (DC), excluding Seoul St. Mary's Hospital such as Samsung Medical Center, Seoul National Cancer Center, and Chung-Ang University Hospital. As the adequacy of insurance benefits was recognized by the Drug Benefit Evaluation Committee last month after passing the first HIRA Cancer Disease Review Committee in January, it is expected to be quickly linked to actual prescriptions if the registration of Lorviqua is confirmed. It remains to be seen whether Pfizer, the first developer of ALK anticancer drugs, will be able to increase its market share. This drug was designated as a rare drug in March last year, and in July, it was approved in Korea for use when Alecensa or Zykadia was previously treated with a primary ALK inhibitor or Xalkori and at least one other ALK inhibitor as a treatment. The third-generation drug, Lorviqua, can be an alternative to patients with subsequent resistance, such as the first-generation drug, Xalkori, and the second-generation drugs, Zykadia and Alecensa. If Xalkori was used in the primary therapy, Lorviqua could be used after the second generation drug, and if the first generation drug was used, Lorviqua could be used in the second. Until now, if resistance developed in secondary drugs, chemotherapy had to be used because there was no target treatment available. G1202R is the most common resistance mutation after second-generation drug treatment, and depending on the drug, F1174L (Zykadia), I1171T/N/S (Alecensa), and E1210K (Alunbrig) appear. Lorviqua works on all known resistant mutations. Lorviqua has added indications of primary therapy for non-small cell lung cancer in Europe. The approval was made based on the results of a phase 3 CROWN study. In this study, Lorviqua demonstrated improvement efficacy in indicators such as death risk and ORR compared to Xalkori.
- Company
- Janssen takes sole lead in the ₩50 billion PAH market
- by Kim, Jin-Gu May 27, 2022 05:56am
- Janssen Korea is solidifying its lead in the ₩50 billion pulmonary arterial hypertension market in Korea. Whether the company will be able to maintain the share it has built up so far after terminating the co-promotion agreement with Handok remains a large variable. ◆The market for the rare disease pulmonary arterial hypertension expands to record ₩50 billion According to the pharmaceutical market research institution IQVIA, the market size for pulmonary arterial hypertension treatments last year was estimated at ₩51.4 billion. This market is steadily expanding with the discovery of new patients. Sales in the market in Q1 this year recorded ₩13.8 billion, a 12% YoY increase from the ₩12.2 billion in Q1 last year. The market size increased 51% in the past 4 years from the ₩9.1 billion in Q1 2018. Change in sales trend of treatments for pulmonary arterial hypertension (Unit 100 million won, Data: IQVIA) Pulmonary arterial hypertension is classified by function into three groups by the World Health Organization (WHO). Class 1 patients may be administered calcium channel blockers (CCB) that are widely used for hypertension treatment. For conditions that fall into WHO Class 2-3 may use endothelin receptor antagonists such as ambrisentan, bosentan, macitentan, or prostacyclin analogs such as beraprost, epoprostenol, iloporst, treprostinil, selexipag. In some cases, erectile dysfunction treatments such as sildenafil and tadalafil are prescribed. ◆Janssen Korea settles as sold lead in the market with its 3 drugs By company, Janssen Korea was found to have the sole lead in the market. Janssen Korea’s share accounted for 47% of the entire market in Q1 this year, followed by Anterogen (18%), Jeil Pharmaceutical (11%), and GSK (11%). Picture of OpsumitJanssen Korea owns 3 types of pulmonary arterial hypertension treatments - Opsumit (macitentan), Uptravi (selexipag), and Tracleer (bosentan). Opsumit has the highest sales among WHO Functional Class 2-3 treatments. Since its release in 2016, sales had steadily increased to record ₩16 billion last year. The drug sold ₩4.3 billion in Q1 this year, which is a 112% YoY increase from the same period last year (₩3.9 billion) Janssen Korea’s other treatments are also showing even growth. Uptravi and Tracleer have all raised ₩1.1 billion in sales in Q1 this year. This is a 5% YoY increase from the sales made in Q1 last year. ◆Janssen Korea sets out to stand alone in the market…will it be able to shake off its competitors?… The interest is focused on whether Janssen Korea will be able to maintain its sold lead in the market. Janssen recently concluded its long partnership with Handok. Handok first introduced Tracleer to Korea in 2006. At the time, the company was in charge of domestic sales of the product that was produced by Actelion. Handok then also took charge of selling Opsumit in 2016 and Uptravi in 2017 that followed. Handok maintained the exclusive sales agreement for the drugs even after Actelion was acquired by Johnson & Johnson in 2017. However, Janssen Korea and Handok concluded their domestic co-promotion agreement at the end of last year. Therefore, Janssen Korea is now solely in charge of the drugs’ domestic sales. Janssen Korea is now left with the challenge of avoiding the pursuits of Anterogen’s ‘Remodulin (Treprostinil)’ and GSK’s Volibris (ambrisentan) on its own. Quarterly sales of major treatments for pulmonary arterial hypertension (Unit 100 million won, Data: IQVIA) Anterogen received approval for Remodulin in 2010. Although the drug did not show good performance earlier in its release, being an injection type with inconvenient administration, its presence and sales have rapidly increased since 2019. Remodulin's sales more than tripled in the past three years from ₩2.8 billion in 2018 to ₩9 billion last year, and then recorded sales of ₩2.5 billion in Q1 this year. In the case of GSK’s Volibris, sales rose 57% in three years from the ₩3.3 billion in 2018 to ₩5.2 billion last year. In Q1 this year, the drug raised sales of ₩1.4 billion, a 17% YoY increase from Q1 last year.
- Company
- Tremfya reimb. expanded to psoriatic arthritis
- by Eo, Yun-Ho May 27, 2022 05:56am
- The IL-23 inhibitor 'Tremfya’ is now applied insurance benefit in psoriatic arthritis. The Ministry of Health and Welfare issued a notice of amendment and extended the reimbursement standard of Tremfya as of the first of this month. With the amendment, Tremfya may now be reimbursed in patients with active or progressive psoriatic arthritis who show an inadequate response to TNF-α inhibitor or IL-17 inhibitor or need to discontinue the use of such drugs due to contraindication or adverse events. Psoriatic arthritis is a chronic progressive immune disorder that is accompanied by joint swelling (inflammation), enthesitis (inflammation where a tendon or ligament attaches to bone), dactylitis (severe inflammation in the fingers and toes), and pain in the hand and feet areas. No cure exists for psoriatic arthritis until now, and despite the availability of treatment options, many patients are experiencing symptoms that affect their ability to perform daily activities. Around 9% of psoriasis patients in Korea are known to develop psoriatic arthritis. Tremfya received approval as the first IL-23 inhibitor to treat active psoriatic arthritis in adult patients who had responded inadequately or were intolerant to disease-modifying anti-rheumatic drugs (DMARDs). Meanwhile, Tremfya was approved as a treatment for adult patients with plaque psoriasis in April 2018 and as a treatment for adult patients with palmoplantar pustulosis in May 2019, and the indications were applied insurance benefits in September 2018 and May 2021, respectively.
- Company
- Soliris to Ultomiris...generation shift picks up speed
- by Kim, Jin-Gu May 26, 2022 05:56am
- The generation shift between Handok’s paroxysmal nocturnal hemoglobinuria treatments Soliris (eculizumab) and Ultomiris (ravulizumab) is gaining speed. With Ultomiris quickly replacing Soliris, Handok’s strategy of checking the release of Soliris’s biosimilars is also being considered a success. ◆Sales of Soliris drop 75%… replaced by its follow-on Ultomiris According to the market research institution IQVIA on the 24th, Soliris’s sales in Q1 this year recorded ₩2.8 billion. This is a 76% drop from the ₩11.4 billion it had made in Q1 2021. However, the rise in Ultromiris’s sales more than made up for the reduced sales of Soliris. Ultromiris raised ₩9.6 billion in sales in Q1 this year, exceeding the reduction in sales seen with Soliris (₩8.6 billion). Quarterly sales of Soliris and Ultomiris (Unit: 100 million won, IQVIA) Ultromiris is Soliris’s follow-on drug that has reduced the number of required administrations. Ultomiris can be administered every 8 weeks as maintenance therapy after the initial dose. However, Soliris needs to be administered biweekly. The drug was developed by Alexion (now AstraZeneca) and Handok is in charge of its domestic sales. Ultromiris started generating sales in Q3 after the drug was listed for reimbursement in June last year. Ultromiris had been showing high performance since its reimbursement, generating ₩8.9 billion in Q3, then ₩10.7 billion in Q4 last year. Ultomiris drew much attention in the prescription field since its reimbursement listing. According to the Health Insurance Review and Assessment Service, Ultomiris received 47 applications for prior approval in the first month of June 2021 alone. Only 9 new applications for prior approval were filed for Soliris in the same period. Soliris and Ultomiris, which were both listed as ultra-high-priced drugs, require prior approval on their eligibility for insurance reimbursement. The institutions that apply for prior approvals must administer the drug within 60 days of receiving HIRA’s deliberation results. Ultomiris’s prior approval applications amounted to 67 in the second half of last year. New applications for Soliris’s prior approval in the same period were only 16. Among these, only 1 new application was filed for the prior approval of Soliris to treat PNH, the indication that is also held by Ultomiris. The other 15 new applications were filed for the treatment of atypical Hemolytic Uremic Syndrome, an indication not covered by Ultomiris. ◆Handok chose ‘speed’ over ‘price’ to contain the rise of its biosimilars Soliris(left), Ultomiris (right) Handok’s reimbursement listing strategy is also receiving attention with the speedy generation shift between Soliris and Ultomiris. Handok received marketing authorization for Ultomiris in May 2020. In the process of receiving reimbursement approval, the drug’s insurance price was set lower than the weighted average of Soliris (₩5,598,492), at ₩5,132,364 per vial. At the time, the interpretation that Handok focused on ‘speed’ rather than ‘price’ had prevailed. Ultimately, Handok succeeded in listing Ultomiris for reimbursement in only 10 months since it applied for insurance benefits in August 2020 as planned. It is interpreted that Handok made such a decision with Soliris’s biosimilars in mind. In Korea, Samsung Bioepis and Isu Abixs are currently developing Soliris biosimilars. Handok's strategy was to quickly register Ultomiris before the biosimilars in development enter the market, and drive prompt switching to the follow-on drug. From this year’s Q1 results, it is evaluated that Handok's fast registration strategy to contain biosimilars was successful to some extent with the rapid switching of Soliris to Ultomiris. PNH is a life-threatening rare blood disease characterized by the destruction of red blood cells by the complement component that is part of the immune system. Without treatment, 4 out of 10 patients die within 5 years after diagnosis. The survival rate of those who are treated with Soliris or Ultomiris has been found to improve to 95.5%. In Korea, around 200 patients suffer from PNH.
- Company
- Avastin’s Q1 sales drop sharply… future sales prospects?
- by May 25, 2022 05:47am
- Roche’s blockbuster anticancer drug ‘Avastin (bevacizumab) has recorded the lowest quarterly sales in 5 years. The drug had been much influenced by the drug price cut that followed the introduction of its biosimilars. However, whether the drop will continue remains to be seen due to the rise of new variables from the additional price cut applied recently, the indication expansion to liver cancer, and the possibility of intensified competition among biosimilars this year. ◆Avastin’s sales drop sharply for 2 consecutive quarters… due to a 30% price cut According to the pharmaceutical market research institution IQVIA, Avastin’s sales in Q1 this year were ₩19.3 billion, a 32.6% YoY decrease from the ₩28.7 billion it made in the same period last year. Avastin is a blockbuster drug that has made ₩100 billion in annual sales over the past 5 years. Avastin inhibits VEGF, the main protein involved in inducing angiogenesis to create an antitumor effect. It is used in various cancer types including breast cancer, non-small cell lung cancer, renal cell carcinoma, and ovarian cancer. Avastin’s sales, which recorded ₩92 billion increased to ₩104.5 billion in 2018, and then ₩119.3 billion the next year. However, sales fell to ₩118.1 billion in 2020 and then dropped 4.9% last year to record ₩112.3 billion. Avastin's sales decline began in earnest in Q4 last year. Avastin's sales, which reached ₩30.9 billion in Q3 last year, fell 27.2% to ₩22.5 billion in Q1 this year. Then, in the first quarter of this year, it fell to ₩19.3 billion. This is the first time Avastin’s quarterly sales recorded less than ₩20 billion in the past five years. The sales drop was greatly influenced by the price cut that was made due to the introduction of its biosimilars. Samsung Bioepis received approval for the first Avastin biosimilar ‘Onbevzi’ in March last year and entered the market in earnest after being listed for insurance reimbursement in September. With Onbevzi’s listing, Avastin’s price ceiling fell 30% in October last year. Price of Avastin 0.1g/4mL fell from ₩330,387 to ₩231,271 and Avastin 0.1g/16mL fell from ₩1,077,531 to ₩752,746, respectively. In other words, the company received a sales hit corresponding to the 30% price cut. Avastin’s sales drop increased greater with Onbevzi generating ₩1.8 billion in sales in Q1 this year, and Samsung Bioepis is attempting to expand its market and signed a co-promotion agreement for the sale of Onbevzi in Korea. Onbevzi’s price was set at 63% of Avastin’s price, at ₩208,144 (0.1g/4mL) and ₩677,471 (0.4g/16mL). ◆Reimbursement expansion, additional price cuts, intensified competition….entangles the bevacizumab market Although Avastin’s sales dipped in the recent 2 quarters, whether the drop will continue remains unknown. For one, Roche received reimbursement approval for the combination of Avastin and its cancer immunotherapy ‘Tecentriq’ in liver cancer. In addition, other variables such as the additional price cuts, difference in price with its biosimilars, entry of additional competitors, etc had risen recently. On April 29th, the Ministry of Health and Welfare assigned reimbursement standards for the Tecentiq+Avastin combination therapy in the first-line treatment of hepatocellular cancer. This is the first time reimbursement was applied to a combination therapy that uses cancer immunotherapy in liver cancer. The Tecentiq+Avastin combination therapy may now be used as a first-line treatment option with other existing first-line treatments – Nexavar and Lenvima. This reimbursement extension has laid the foundation for Avastin to rebound in sales. Also, the reimbursement extension had made Avastin’s drug price similar to its biosimilars. With insurance benefits extended to liver cancer, the price ceiling of Avastin has been reduced by an additional 5% since October last year. From this month, the price ceiling of Avastin will be ₩218,782 (0.1g/4mL) and ₩712,098 (0.4g/16mL). The price difference between the 4mL doses is only ₩1,638 and ₩34,627 for the 16 mL dose. This reduced gap in price is analyzed to have decreased the biggest strength held by its biosimilars – the price competitiveness. On the other hand, Avastin’s biosimilar market has been unfolding in a more complex manner. The industry prospects are that Pfizer's Zirabev which was approved in May last year, and Alvogen’s Alymsis which was approved in January will join in the competition this year. On top of that, Celltrion also applied for permission for its 'CT-P16' in October last year. The Avastin biosimilar market, which had only one product, has quickly formed a multilateral competition structure. In particular, each of the Avastin biosimilars is showing a difference in price and its indications, and some biosimilar developers are in a patent dispute with the original company over some indications, including ovarian cancer. Recently, Alvogen lost to Roche in one patent invalidation trial. Its impact on the original Avastin will vary depending on the outcome of further lawsuits.
- Company
- Yuhan Leclaza's first-quarter sales were 3.2 billion won
- by Chon, Seung-Hyun May 24, 2022 05:55am
- Yuhan's new anticancer drug Leclaza posted sales of 3 billion won in the first quarter. It has continued to rise since it entered the domestic market in earnest in the second half of last year. It is expected to surpass 10 billion won in annual sales for the first time among new anti-cancer drugs developed in Korea. According to IQVIA, on the 23rd, Leclaza recorded 3.2 billion won in sales in the first quarter. Leclaza is a non-small cell lung cancer treatment approved as the 31st new drug developed in Korea in January last year. Patients with local progressive or metastatic non-small cell lung cancer who developed T790M resistance after administration of the first and second generation epithelial cell growth factor receptor (EGFR) tyrosin kinase inhibitor (TKI) are eligible for administration. It acts as a mechanism to suppress the proliferation and growth of lung cancer cells by interfering with the signal transmission involved in lung cancer cell growth. Leclaza made its market debut in July last year with the listing of health insurance benefits. Leclaza made 4.1 billion won in sales in the second half of last year alone. The first sales of 1.5 billion won occurred in the third quarter of last year and 2.6 billion won worth of sales were sold in the fourth quarter. Cumulative sales have been estimated at 7.3 billion won since the third quarter of last year. Since anticancer drugs usually used in large medical institutions can be prescribed after the passage of the drug committee, it takes a considerable amount of time for sales to occur at the beginning of the release. Leclaza can be prescribed at more than 30 medical institutions, including Seoul National University Hospital, Sinchon Severance Hospital, Samsung Medical Center, and Asan Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Hwasun Chonnam National University Hospital, Chilgok Kyungpook National University Hospital, and Pusan National University Hospital. At this rate, it seems likely that annual sales will surpass 10 billion won in the second year of its release. None of the new anticancer drugs developed by domestic pharmaceutical companies has yet exceeded 10 billion won in annual sales. Domestic developed anticancer drugs licensed before Leclaza include Supect of Ilyang Pharmaceutical, Chong Kun Dang's Camtobell, Samsung's Riavax, and Hanmi's Oilta. Among them, Supect recorded 7.4 billion won in sales last year. Sales in the first quarter of this year are 1.9 billion won. Supect, which was approved as the 18th new drug developed in Korea in January 2012, is a drug used as a treatment for chronic myeloid leukemia. However, compared to the anticancer drugs of multinational pharmaceutical companies used for similar purposes to Leclaza, there are hurdles to overcome in the future. EGFR targeted anticancer drugs approved for use in Korea before the release of Leclaza include Iressa and Tarceva, the first-generation drugs, Giotrip and Vizimpro, and Tagrisso. Tagrisso posted 26.4 billion won in sales in the first quarter, up 8.0% from a year earlier. Tagrisso is a secondary treatment prescribed for non-small cell lung cancer (NSCLC) patients who developed resistance after administration of existing EGFR tyrosin kinase (TKI), such as Iressa, Tarceva, and Giotrif. It is called the same third-generation drug as Leclaza in that it overcomes the resistance of existing EGFR-TKI. Tagrisso, which received domestic permission in 2016, saw its sales increase significantly after applying health insurance benefits in December 2017. Tagrisso surpassed 10 billion won in sales in the third quarter of 2018 and has been recording 20 billion won in sales since the second quarter of 2019. It recorded sales of about 100 billion won for two consecutive years in 2020 and last year. Beringer Ingelheim's Geotrip, which is classified as a second-generation EGFR target anticancer drug, recorded 5.8 billion won in sales in the first quarter, up 13.2% from the previous year. Iressa and Tarceva, the first-generation drugs, showed sales of 3.4 billion won and 1 billion won in the first quarter, respectively. Yuhan Corporation has secured a total of $150 million in technology fees with Leclaza. Yuhan Corporation exported Leclaza to Janssen Biotech in November 2018. At this time, he received a deposit of $50 million without obligation to return it. Yuhan Corporation received $35 million in milestone from Janssen in April 2020. Janssen paid additional milestones to Yuhan Corporation when he began clinical trials of combination therapy with Amivantamab and Leclaza at the time. In November 2020, Janssen paid an additional $65 million to Yuhan Corporation when it began recruiting subjects for this clinical trial.
- Company
- Duodart may be prescribed at general hospitals in Korea
- by Eo, Yun-Ho May 24, 2022 05:55am
- The combination drug ‘Duodart’ that contains ‘dutasteride’ and ‘tamsulosin’ may be prescribed in general hospitals in Korea. According to industry sources, Duodart, GSK Korea’s fixed-dose combination drug for benign prostatic hyperplasia (BPH), has recently passed the drug committee (DC) review of Sinchon Severance Hospital and is undergoing landing procedures at major medical institutions across the country. The drug was granted insurance benefits starting in March this year. Duodart is reimbursed for ?? patients with ‘benign prostatic hyperplasia (BPH)’ who satisfy both of the following conditions: International Prostate Symptom Score (IPSS) of 8 or higher and ▲ Ultrasonography shows a prostate size of 30ml or larger, or Digital rectal examination shows moderate or higher BPH or the patient’s prostate-specific antigen (PSA) level is 1.5ng/ml or higher. Duodart is the first fixed-dose combination of dutasteride and tamsulosin introduced for BPH in Korea and can be administered orally once daily in a capsule form to treat moderate-to-severe symptoms of BPH. The drug was approved by the EU and the US FDA in 2010 and approved in May last year in Korea. The combination of the 5α-reductase inhibitor (dutasteride) and antagonist of α1a-adrenoreceptors (tamsulosin hydrochloride) is recommended in global clinical practice guidelines. Rapid symptom improvement and long-term disease progression control were expected through the combination of the two drugs with complementary mechanisms of action. In real-world data, patients using Duodart showed statistically significantly higher compliance compared with those using 5α-reductase inhibitor/ Alpha1-adrenergic antagonist free-combination therapy. The European Association of Urology (EAU) currently recommends introducing the 5α-reductase inhibitor (5-ARI) and Alpha1-adrenergic antagonist combination therapy in the early stages of treatment in patients with BPH with accompanying lower urinary tract symptoms (LUTS). The American Urological Association (AUA) also recommends using combination therapy in the early stages of BPH treatment. According to the CombAT study, the clinical trial that became the basis for Duodart’s approval, patients in the dutasteride-tamsulosin combination therapy group showed rapid symptom improvement at Month 3 like the tamsulosin monotherapy group. Also, the combination demonstrated superior symptom improvement over either monotherapy from Month 9, which lasted until Month 48. In addition, the combination therapy reduced the risk of BPH symptom progression and risk of AUR-related surgery than either monotherapy.
- Company
- Janssen makes first bid into lung cancer mkt with Rybrevant
- by May 24, 2022 05:55am
- “We will work to make Rybrevant, which had been first approved to treat EGFR exon 20 insertion mutations, the No.1 option for lung cancer patients in Korea.” Janssen Korea expressed so at the press conference that was held on the 23rd to celebrate the launch of Rybrevant in Korea. Rybrevant (amivantamab) received marketing authorization from the Ministry of Food and Drug Safety in February and was officially released this month. As the first and only dual inhibitor that targets both the EGFR exon 20 insertion mutation and MET, the drug is approved for use in patients whose disease has progressed during or after platinum-based chemotherapy treatment. According to the CHRYSALIS trial that became the basis of Rybrevant’s approval, the overall response rate (ORR) of the Rybrevant monotherapy-treated group was 40%. 4% of the participants achieved a complete response (CR), and 36% achieved a partial response (PR). The median duration of response (DOR) was 11.1 months. Based on such results, the National Comprehensive Cancer Network guidelines recommend Rybrevant as a treatment option for patients with EGFR exon 20 insertion mutation NSCLC after platinum-based chemotherapy treatment. Professor Byoung-Chul Cho, Chief of Yonsei Cancer Center (Professor, Division of Medical Oncology, Yonsei Severance Hospital) who first identified the potential of Rybrevant in exon 20 insertion mutations, said, “While conducting a Phase I trial on lung cancer patients with Rybrevant, we found that the drug showed a dramatic effect in patients with exon 20 insertion mutations. After identifying its potential through various preclinical trials, we quickly initiated the CHRYSALIS study to come up with results.” Exon 20 insertion mutations are present in around 10% of all patients with EGFR mutations. Due to its various subtypes, patients with the mutation are unable to achieve desired results with existing EGFR-targeted cancer therapies. Compared to the PFS of patients with common EGFR mutations (Exon 19 deletion, L868R) which was 11 months, the PFS of patients with Exon 20 insertion mutations was a mere 3 months. The 5-year survival rate of patients with common EGFR mutations is 19%, but only 8% in patients with Exon 20 insertion mutations. This was why the need for a new targeted therapy had been rising for the specific mutation. Professor Cho believes that Rybrevant has a high potential to expand to other indications as it simultaneously targets both the EGFR and MET mutations and has a unique mechanism of action that activates immunity by engaging NK cells, monocytes, and macrophages. Cho said, "Exon 20 insertion mutation presents in various subtypes. Subgroup analysis results of the CHRYSALIS study showed that Rybrevant showed an even response across various subtypes. Also, Rybrevant is promising as it has an immunological mechanism in addition to the target inhibition effect held by targeted therapies." Janssen Korea is also conducting various clinical trials to test the expandability of Rybrevant. A Phase III trial in combination with chemotherapy and a Phase I study of Rybrevant monotherapy on MET exon 14 skipping mutation is underway. The most anticipated combination is its combination with Leclaza (lazertinib) to target common EGFR mutations. The company is conducting 3 clinical trials using the Rybrevant+Leclaza combination. Two of the trials are Phase III trials, MARIPOSA-2, which identifies the potential of Rybrevant+Leclaza+chemotherapy as a treatment used after Tagrisso, and the MARIPOSA trial which directly compares Rybrevant+Leclaza to Tagrisso, is underway. Also, Janssen Korea is exploring Rybrevant’s potential in various solid cancers including breast cancer and ovarian cancer. Professor Cho said, “EGFR and MET are key targets that are commonly present in various other solid cancers as well. The fact that Rybrevant is a bispecific antibody that inhibits both at the same time holds immense potential, and with the various clinical trials in progress, we may expect the drug to expand to other indications in the future.”
- Company
- Alvogen, 1 in 3 failed patent attempts for Avastin
- by Kim, Jin-Gu May 24, 2022 05:55am
- Alvogen Korea failed to cross the last hurdle in the Roche anticancer drug Avastin patent challenge. It challenged three patents, but succeeded in overcoming only two and failed one. The Korean Intellectual Property Tribunal recently dismissed the Avastin patent invalidation trial filed by Alvogen Korea against Roche. As a result, the original company Roche succeeded in defending one out of three related patents in the first trial. Roche has registered a total of four patents in Avastin. It is one patent for substance and three patents for use. One patent for substances registered in Korea has already expired in April 2018. In August last year, Alvogen filed a series of invalidation trials for the three patents. The results of the first trial related to this began to come out last month. In the case of two use patents that expire in February 2031, Alvogen succeeded in invalidating them last month and early this month. In the case of a patent for use that expires in February 2033, the Korean Intellectual Property Tribunal sided with the original company. Alvogen's plan to develop Avastin biosimilar while overcoming related patents has also become inevitable. As a result, the pharmaceutical industry predicts that Alvogen will continue the patent dispute through the patent court appeal. Avastin is a blockbuster anticancer drug developed by Roche and is used for treatment of non-small cell lung cancer, metastatic direct bowel cancer, metastatic breast cancer, and glioblastoma. According to IQVIA, a pharmaceutical market research firm, Avastin's domestic sales reached 112.3 billion won last year.
