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    Home > Medical News > Latest Medical News > [exclusive] 2018 pharmaceutical giant new drug R & D event (Merck)

    [exclusive] 2018 pharmaceutical giant new drug R & D event (Merck)

    • Last Update: 2019-01-21
    • Source: Internet
    • Author: User
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    In this paper, Merck's press release is used to sort out the company's new drug R & D events in 2018, in which only the highest trends are recorded for each drug indication 1、 New drug approval dynamics 1 FDA / EMA approval dynamics of (s) NDA or MAA (1) pabolizumab new indications ① treatment of relapsed local advanced or metastatic Merkel cell carcinoma (MCC) (accelerated approval) [approval agency / approval date] FDA / December 19, 2018 [clinical trial as the basis for approval] phase 2 citn-09 / keynote-017 included 50 patients with local advanced or metastatic MCC who had not received systemic chemotherapy for advanced diseases before The main efficacy results are as follows: [basic epidemiological characteristics of indications] according to the statistics of American Cancer Association, about 2000 confirmed cases of MCC are newly increased in the United States every year ② Adjuvant therapy for patients with stage III melanoma involving lymph nodes after complete resection [approval authority / approval date] EMA / December 17, 2018 [clinical trial for approval] eortc1325 / keynote-054 showed that compared with placebo, pabolizumab significantly prolonged relapse free survival and reduced the risk of relapse or death by 44% (HR = 0.56; 98% CI, 0.44-0.72; P < 0.0001) [basic epidemiological characteristics of indications] in 2018, about 287000 confirmed cases and 60000 deaths were added In Europe, the 5-year survival rate of advanced or metastatic melanoma (stage IV) is about 5-22% (source: Bulletin) [other] SNDA for the new indication of pabolizumab was accepted by FDA on June 25, 2018, and its final decision date is February 19, 2019 ③ HCC patients who had previously received Sola Fini treatment [approval authority / approval date] FDA/2018 November 9th (accelerated approval) [clinical trial as the basis for approval] KEYNOTE-224 trial is a single group, open label, multicenter trial, including 104 HCC patients who had previously received Sola Fini treatment but were in progress or intolerant The main effectiveness results of this test are as follows In addition, among the 18 patients with remission, 89% and 56% of them had remission duration (DOR) ≥ 6 months and ≥ 12 months respectively [basic epidemiological characteristics of indications] HCC is the most common type of liver cancer, accounting for more than 90% of all cases of primary liver cancer According to the data of American Cancer Association, 420300 confirmed cases and 3178 deaths of HCC will be added in the United States in 2019 ④ Combination of carboplatin and paclitaxel (or albumin binding paclitaxel) for the first-line treatment of patients with metastatic squamous NSCLC [approval authority / approval date] FDA / October 30, 2018 (accelerated approval) [clinical trial as the basis for approval] the results of keynote-407 test confirm that the survival benefit of the combination chemotherapy of pabolizumab is significantly better than that of the chemotherapy alone The specific effectiveness results are shown in the table below ⑤ Combination of pemetrexed and platinum chemotherapy for the first-line treatment of metastatic non squamous NSCLC patients without EGFR or ALK gene mutation [approval agency / approval date] EMA / September 10, 2018, FDA / August 20, 2018 [clinical trial as the basis for approval] the results of keynote-189 trial in phase 3 confirmed that, compared with chemotherapy alone, the combination chemotherapy of pabolizumab could reduce the risk of death by half (HR = 0.49 [95% CI, 0.38-0.64]; P < 0.00001) ⑥ Refractory primary mediastinal large B-cell lymphoma (pmbcl) [approval agency / approval date] FDA / June 13, 2018 (accelerated approval) [clinical trial as the basis for approval] keynot-170 trial is a multicenter, open label, single group clinical trial involving 53 pmbcl patients The results showed that the objective response rate (ORR) was 45% (95% CI: 32,60), the complete response rate and partial response rate were 11% and 34% respectively, while the duration of response (DOR) was less than the median (1.1 + ~ 19.2 + months) ⑦ Treatment of recurrent or metastatic cervical cancer patients with tumor expression of PD-L1 (CPS ≥ 1) [approval authority / approval date] FDA / June 12, 2018 (accelerated approval) [clinical trial as the basis for approval] the e-cohort data in the multicenter, non randomized, open label, multi cohort trial (keynote-158) included 77 (79%) cervical cancer patients with tumor expression of PD-L1 and CPS ≥ 1 who had received at least first-line chemotherapy in the past The objective response rate, complete response rate and partial response rate were 14.3% (95% CI), 7.4-24.1), 2.6% and 11.7% Among the 11 subjects with remission, the duration of remission (DOR) did not reach the median value (4.1-18.6 + months), while 91% of the subjects with dor ≥ 6 months (2) Trends of approval for new indications of olapalene ① maintenance treatment of patients with advanced epithelial ovarian cancer, salpingocarcinoma or primary peritoneal cancer with harmful or suspected harmful BRCA mutation after complete or partial remission after first-line platinum chemotherapy [approval agency / approval date] FDA / December 19, 2018 [clinical trial as the basis for approval] the results of the key phase III Solo-1 trial showed that for patients with brcam advanced ovarian cancer who had complete or partial remission after previous chemotherapy with platinum, the risk of disease progression or death in the olapalin group was 70% lower than that in the placebo group, and the safety characteristics of olapalin in this trial were consistent with the previous study [basic epidemiological characteristics of indications] according to the global cancer statistics report released by the World Health Organization (who), there are about 200000 new cases of ovarian cancer every year in the world, and more than 150000 people die of the disease every year [other] the SNDA of the indication was accepted by FDA on November 12, 2018; olapaley was originally developed by AstraZeneca, which reached a synthetic development agreement with Merck in July 2017 ② The main efficacy results of Solo-2 and study No 19 based on the previous maintenance treatment of platinum sensitive advanced epithelial ovarian cancer, salpingocarcinoma or primary peritoneal cancer patients [approval agency / approval date] EMA / May 8, 2018 [clinical trial as the basis of approval] with complete or partial remission after platinum containing chemotherapy are shown in the table below (3) Doravirin's single (trade name: piraltro) and doravirin / lamivudine / tenofovir fumarate compound (trade name: delrigo) [approval agency / approval date] EMA / November 28, 2018, FDA / August 30, 2018 [mechanism of action] doravirin is a non nucleoside reverse transcriptase inhibitor (NNRTI) [indications] currently and in the past, HIV-1 infected people who are not resistant to NNRTI [clinical trials as the basis for approval] two key randomized, multicenter, double-blind, active control phase 3 clinical trials, drive-ahead and drive-forward, respectively, confirmed the non inferiority of delrigo and pifeltro compared with their respective active controls The overall effectiveness results are shown in the table below The proportion of subjects who quit the study ahead of time due to adverse reactions in delstrigo group was lower than that in the active control group (3% and 6%, respectively) The incidence of adverse reactions ≥ 5% in the delstrigo group included nausea (6%) and headache (5%) The results of two clinical trials with HIV-1 infected patients who had not been treated before showed that the proportion of subjects who withdrew from the study in advance due to adverse reactions in doravirine group (2.8%) was lower than that in feverine group (6.1%) (treatment difference was - 3.4%, P = 0.012) Adverse reactions with incidence ≥ 5% in the pifeltro group included nausea (6%) and headache (5%) (4) Revatinib (trade name lenvima) [approval agency / approval date] FDA / August 16, 2018 [mechanism of action] kinase inhibitor [indication] first line treatment of unresectable HCC patients [clinical trial as the basis for approval] the results of the three-stage reflect test confirmed that, for patients with non resectable HCC who have not been treated before, the effect of rivatinib on improving overall survival (OS) was not inferior to that of sorafenib, while the effect on improving PFS and orr was statistically significant and clinically significant better than that of the latter , as shown in the table below [Others] lovatinib is developed by Merck in cooperation with Japanese Weicai company (original research) (an agreement was reached in March 2018) 2 FDA / EMA rejected (s) no NDA or MAA, new drug application / review dynamics 1 New drug application (1) rolling application to launch Ebola virus vaccine V920 [date] November 13, 2018, expected to complete the certification of breakthrough therapy granted by [indications] Ebola virus [other] V920 to V920 in July 2016 2 New drug application with progress (1) FDA has given priority to the review of SBLA for new indications of pabolizumab [date] September 12, 2018 [indications] patients with locally advanced or metastatic squamous or non squamous NSCLC expressing PD-L1 (TPS ≥ 1%) and without EGFR or ALK genomic tumor mutation [final decision date] January 11, 2019 (but not approved as of January 14, 2019) [clinical trial as the basis for declaration] the results of the three-phase keynote-042 trial were disclosed at the annual meeting of ASCO 2018, and the overall effectiveness results are as follows (2) FDA has given priority to review the SBLA of new indications of hpv9-valent vaccine [date] June 13, 2018 [indications] for the prevention of specific HPV related cancer and disease in men and women aged 27-45 [final decision date] October 6, 2018 However, as of January 14, 2019, Merck did not disclose the further progress of the SBLA 3 No application for frustrated new drugs 3 Dynamic clinical trials 1 Advanced clinical trials (1) clinical trials reach the end point after the launch of olapari ① phase 3 solo-3 trial [published time] December 20, 2018 [indications] patients with BRCA mutant advanced ovarian cancer who have used at least two lines of chemotherapy before [main results / Conclusion] the effect of olapalin on increasing the objective response rate (ORR) and prolonging the progression free survival (PFS) was significantly better than that of chemotherapy, and the safety characteristics of olapalin were also consistent with previous studies [significance] the solo-3 trial is the third clinical trial in which olapari has achieved positive results, and it is also the first time to confirm that PARP inhibitors are more effective than chemotherapy in patients with advanced ovarian cancer ② Olympiad test [date of publication] April 15, 2018 [indications] gbrca mutant HER2 negative metastatic breast cancer patients [main results / conclusions] although the test efficacy of this test is not enough to confirm the significant difference, the median total survival period (OS) of olapari group and chemotherapy group is 19.3 months and 17.1 months respectively (hr0.90,95% ci0.66-1.23; P = 0.513) In the final OS data entry point, the proportion of patients in olapali group and chemotherapy group who still adhere to the treatment was 13% and 0%, respectively Although the overall population analysis failed to confirm the efficacy of olapalin compared with chemotherapy, the results of subgroups showed that the effect of prolonged OS of olapalin was significantly better than that of chemotherapy group, with the median OS of 22.6 months vs 14.7 months (hr0.51,95% ci0.29-0.90; nominalp = 0.02) [significance] Merck and AstraZeneca have submitted relevant MAA to EMA on April 3, 2018 based on the test (2) Progress in clinical trials of pabolizumab after marketing ① keynote-181 [date of publication] November 14, 2018
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