{"id":13070,"date":"2021-08-10T17:54:17","date_gmt":"2021-08-10T12:24:17","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=13070"},"modified":"2021-08-31T14:36:22","modified_gmt":"2021-08-31T09:06:22","slug":"pharma-happenings-for-merck-abbvie-incyte-aprea-eisai","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-for-merck-abbvie-incyte-aprea-eisai","title":{"rendered":"Merck\u2019s Keytruda Approval; Abbvie\u2019s Venetoclax; Aprea&#8217;s Eprenetapopt; CRL to Incyte\u2019s Retifanlimab; Keytruda\/Lenvima for Endometrial Cancer"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-69f915d9677e2\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-69f915d9677e2\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-for-merck-abbvie-incyte-aprea-eisai\/#FDA_Approves_Keytruda_in_Both_Adjuvant_and_Neoadjuvant_Setting_in_High-Risk_Early-Stage_TNBC\" >FDA Approves Keytruda in Both Adjuvant and Neoadjuvant Setting in High-Risk Early-Stage TNBC<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-for-merck-abbvie-incyte-aprea-eisai\/#Following_Inqovi_and_Reblozyls_Approval_Abbvies_Venetoclax_is_Expected_To_be_the_Next_Big_Move_in_the_MDS_Market\" >Following Inqovi and Reblozyl\u2019s Approval, Abbvie\u2019s Venetoclax is Expected To be the Next Big Move in the MDS Market<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-for-merck-abbvie-incyte-aprea-eisai\/#Aprea_Therapeutics_Eprenetapopt_Combined_with_Azacitidine_Demonstrates_Efficacy_in_TP53-positive_MDS_and_AML\" >Aprea Therapeutic\u2019s Eprenetapopt Combined with Azacitidine Demonstrates Efficacy in TP53-positive MDS and AML<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-for-merck-abbvie-incyte-aprea-eisai\/#FDA_Issues_a_Complete_Response_Letter_CRL_to_Incytes_Retifanlimab_for_Locally_Advanced_or_Metastatic_Squamous_Cell_Carcinoma_of_the_Anal_Canal_SCAC_Subgroup\" >FDA Issues a Complete Response Letter (CRL) to Incyte\u2019s Retifanlimab for Locally Advanced or Metastatic Squamous Cell Carcinoma of the Anal Canal (SCAC) Subgroup<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-for-merck-abbvie-incyte-aprea-eisai\/#KeytrudaLenvima_Combo_Dazzles_with_Regular_Approval_in_Endometrial_Cancer\" >Keytruda\/Lenvima Combo Dazzles with Regular Approval in Endometrial Cancer&nbsp;<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-approves-keytruda-in-both-adjuvant-and-neoadjuvant-setting-in-high-risk-early-stage-tnbc\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Keytruda_in_Both_Adjuvant_and_Neoadjuvant_Setting_in_High-Risk_Early-Stage_TNBC\"><\/span>FDA Approves Keytruda in Both Adjuvant and Neoadjuvant Setting in High-Risk Early-Stage TNBC<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In July 2021, the US FDA approved pembrolizumab (Keytruda) for high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as <strong>neoadjuvant treatment<\/strong> and then continued as a single agent as <strong>adjuvant treatment<\/strong> after surgery. This approval was based on <strong>Phase III KEYNOTE-522<\/strong> trial (NCT03036488) and became the <strong>first immunotherapy regimen<\/strong> to be approved in <a href=\"https:\/\/www.delveinsight.com\/report-store\/triple-negative-breast-cancer-tnbc-market?utm_source=blog&amp;utm_medium=news&amp;utm_campaign=v\"><strong>high-risk early-stage TNBC<\/strong><\/a>, marking a milestone for breast cancer patients. Earlier in February 2021, the agency <strong>rejected Merck\u2019s application<\/strong> to approve the drug for this population and requested more data from the pivotal trial. But with the promising results, the FDA changed its decision and approved Merck\u2019s leading candidate in oncology. The FDA also granted regular approval to pembrolizumab combined with chemotherapy for patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1 (combined positive score [CPS] \u2265 10) to which it granted accelerated approval in <strong>November 2020<\/strong>. The Phase III trial (KEYNOTE-522) was the basis of the neoadjuvant and adjuvant approval and the confirmatory trial for the accelerated approval. The results showed that the pembrolizumab regimen resulted in a <strong>37% reduction<\/strong> in the risk of <strong>disease progression<\/strong> and a <strong>28%<\/strong> reduction in the <strong>risk of death. <\/strong>After a median follow-up of 39 months, the pembrolizumab regimen resulted in a <strong>37% reduction <\/strong>in the risk of EFS events vs. the chemotherapy\/placebo regimen.&nbsp;<\/p>\n\n\n\n<p>With this approval, the treatment paradigm is going to change with the inclusion of immunotherapy as part of the regimen for patients with high-risk early-stage TNBC as nearly 30\u201340% of the patients are at risk of relapse after standard neoadjuvant chemotherapy and surgery. The asset is the only competitor in the market till now for early TNBC; however, Roche\u2019s <strong>Tecentriq (Atezolizumab) <\/strong>is also looking to hit the bull\u2019s eye as the company presented the data from the <strong>Phase III IMpassion031 <\/strong>at ESMO 2020 virtual congress, which demonstrated that Tecentriq in combination with chemotherapy <strong>improved pathological complete response<\/strong> for patients with early triple-negative breast cancer (TNBC) when compared to placebo plus chemotherapy. Back then, the company stated that the IMpassion031 study was the second positive Phase III study from Roche demonstrating the benefit of Tecentriq in TNBC and the first Tecentriq study to demonstrate benefit in early TNBC. In addition, Roche is also evaluating Tecentriq<strong> <\/strong>in an <strong>adjuvant setting <\/strong>in Phase III <strong>IMpassion030 trial<\/strong>. Another Phase III investigator-sponsored trial <strong>(A-Brave)<\/strong> is also in progress by Istituto Oncologico Veneto IRCCS, which is investigating Pfizer and Merck KGaA\u2019s <strong>Bavencio (Avelumab) <\/strong>in adjuvant TNBC. The data have not been released despite the primary completion date of June 2021.&nbsp;<\/p>\n\n\n\n<p>We await to see the excitement of the oncologists with these treatment options arrive in the adjuvant and neoadjuvant setting unfolding newer options for this patient population in the near future.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Following_Inqovi_and_Reblozyls_Approval_Abbvies_Venetoclax_is_Expected_To_be_the_Next_Big_Move_in_the_MDS_Market\"><\/span>Following Inqovi and Reblozyl\u2019s Approval, Abbvie\u2019s Venetoclax is Expected To be the Next Big Move in the MDS Market<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The FDA has granted <strong>breakthrough therapy designation<\/strong> (BTD) to the combination of <strong>venetoclax (Venclexta)<\/strong> and <strong>azacitidine (Vidaza)<\/strong> for the treatment of adult patients with previously untreated intermediate-, high- and very high-risk <a href=\"https:\/\/www.delveinsight.com\/report-store\/myelodysplastic-syndrome-market?utm_source=blog&amp;utm_medium=news&amp;utm_campaign=v\">myelodysplastic syndromes (MDS)<\/a> as per the revised International Prognostic Scoring System (IPSS-R) based on the Phase Ib <strong>M15-531 study<\/strong> (NCT02942290). The results from the study which supported the decision of the agency were presented during the <strong>American Hematology Association Annual Meeting and Exposition 2020<\/strong>, which demonstrated that the treatment with venetoclax plus azacitidine led to an objective response rate of <strong>77%<\/strong>, which included complete responses in <strong>42%<\/strong> and marrow CRs in <strong>35%<\/strong>. The median OS was not reached in terms of survival and the <strong>median PFS was 17.5 months<\/strong>.<\/p>\n\n\n\n<p>For high-risk patients with MDS who are not suitable for intensive treatment approaches, HMAs (AZA and DAC) represent the only approved therapeutics and current standard of care. As venetoclax is already approved in acute myeloid leukemia (AML), it would be the only<strong> BCL-2 inhibitor <\/strong>for the <strong>first-line<\/strong> MDS patients ineligible for intensive treatment if approved. As per Delveinsight\u2019s analysis, the asset is expected to enter the market by 2022 and might generate a market size of approximately <strong>900 million<\/strong> in the 7MM countries by 2030. We expect Venetoclax to compete with <strong>Gilead Sciences\u2019 Magrolimab (<\/strong>anti-CD47 monoclonal antibody) and <strong>Takeda\u2019s Pevonedistat <\/strong>(NEDD8-activating enzyme (NAE) inhibitor), both targeting<strong> <\/strong>the same patient population in the first-line setting. Both Pevonedistat and Magrolimab have received the Breakthrough designation; however, we expect Venetoclax to have the edge over both due to its oral route of the formulation.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-aprea-therapeutic-s-eprenetapopt-combined-with-azacitidine-demonstrates-efficacy-in-tp53-positive-mds-and-aml\"><span class=\"ez-toc-section\" id=\"Aprea_Therapeutics_Eprenetapopt_Combined_with_Azacitidine_Demonstrates_Efficacy_in_TP53-positive_MDS_and_AML\"><\/span>Aprea Therapeutic\u2019s Eprenetapopt Combined with Azacitidine Demonstrates Efficacy in TP53-positive MDS and AML<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Recently, Aprea Therapeutics announced the Phase II results from the study evaluating eprenetapopt (APR-246) combined with azacitidine as post-transplant maintenance therapy for patients with <strong>TP53-mutant myelodysplastic syndrome (MDS)<\/strong> and <a href=\"https:\/\/www.delveinsight.com\/report-store\/acute-myeloid-leukemia-aml-market?utm_source=blog&amp;utm_medium=news&amp;utm_campaign=v\"><strong>acute myeloid leukemia (AML)<\/strong>.<\/a> It is an oral next-generation p53 reactivator that has secured the <strong>Breakthrough Therapy, Orphan Drug <\/strong>and<strong> Fast Track designations<\/strong> from the <strong>FDA<\/strong>, and <strong>Orphan Drug designation<\/strong> from the <strong>European Commission <\/strong>for MDS<strong>. <\/strong>The results from the study showed that, of 33 patients enrolled, the <strong>relapse-free survival (RFS)<\/strong> at 1-year post-transplant was <strong>58%,<\/strong> and the <strong>median RFS<\/strong> was <strong>12.1 months. <\/strong>The <strong>overall survival (OS)<\/strong> at 1-year post-transplant was <strong>79%<\/strong>, with a <strong>median OS<\/strong> of <strong>19.3 months<\/strong>. In terms of safety, eprenetapopt plus azacitidine was also a well-tolerated post-transplant regimen for patients with TP53-mutant MDS or AML.<\/p>\n\n\n\n<p>The company recently, in its corporate presentation, stated about the failure of its Phase III trial, which evaluated <strong>eprenetapopt<\/strong> in combination with <strong>azacitidine<\/strong> versus azacitidine alone for the treatment of (tumor protein) TP53 mutant MDS. The company stated that the trial failed to meet its primary endpoint of <strong>complete remission (CR) rate<\/strong> due to dose modifications of eprenetapopt and azacitidine which led to <strong>undertreatment <\/strong>in the experimental arm that negatively impacted efficacy. The company plans to share the findings observed in the Phase II study with the FDA in the <strong>second half of 2021<\/strong> and might present the data during an upcoming medical meeting.<\/p>\n\n\n\n<p>The decision would depend on the FDA, which might or might not ask for the Phase III registration trial in a post-transplant maintenance setting. As per Delveinsight\u2019s analysis, the drug might get approved in <strong>2024 <\/strong>and is expected to target the &lt;10% MDS patients undergoing for transplants.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-issues-a-complete-response-letter-crl-to-incyte-s-retifanlimab-for-locally-advanced-or-metastatic-squamous-cell-carcinoma-of-the-anal-canal-scac-subgroup\"><span class=\"ez-toc-section\" id=\"FDA_Issues_a_Complete_Response_Letter_CRL_to_Incytes_Retifanlimab_for_Locally_Advanced_or_Metastatic_Squamous_Cell_Carcinoma_of_the_Anal_Canal_SCAC_Subgroup\"><\/span>FDA Issues a Complete Response Letter (CRL) to Incyte\u2019s Retifanlimab for Locally Advanced or Metastatic Squamous Cell Carcinoma of the Anal Canal (SCAC) Subgroup<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The FDA issued a <strong>complete response letter<\/strong> <strong>(CRL)<\/strong> to Incyte Corporation in response to the <strong>Biologics License Application (BLA)<\/strong> for the PD-L1 inhibitor, retifanlimab (formerly MGA012), for the treatment of adult patients with metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy.<\/p>\n\n\n\n<p>Back in June 2021, the company announced that the <strong>Oncologic Drugs Advisory Committee (ODAC)<\/strong> of the <strong>US FDA<\/strong> reviewed the BLA for retifanlimab and voted 13-4 against the approval of retifanlimab for patients with SCAC.<strong> <\/strong>The BLA submission is based on data from the <strong>Phase II POD1UM-202 trial, <\/strong>and the results were presented at ESMO 2020, which showed an <strong>objective response rate (ORR)<\/strong> of <strong>14%<\/strong> for retifanlimab monotherapy. The FDA determined that additional data are needed to demonstrate the clinical benefit of retifanlimab for treating patients with advanced or metastatic SCAC. The company is reviewing the letter and might discuss the next steps with the FDA.<\/p>\n\n\n\n<p>As there are no approved options for the SCAC patients who have progressed after first-line chemotherapy, the approval of this drug might mark the entrance of new immunotherapy in historically neglected, yet important, tumor. The drug has been granted <strong>Orphan Drug Designation<\/strong> by the FDA to treat anal cancer, along with <strong>Priority Review in January 2021.<\/strong>&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-keytruda-lenvima-combo-dazzles-with-regular-approval-in-endometrial-cancer\"><span class=\"ez-toc-section\" id=\"KeytrudaLenvima_Combo_Dazzles_with_Regular_Approval_in_Endometrial_Cancer\"><\/span>Keytruda\/Lenvima Combo Dazzles with Regular Approval in Endometrial Cancer&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Back in 2019, the US FDA granted <strong>accelerated approval<\/strong> to the combination of <strong>KEYTRUDA<\/strong> (Pembrolizumab; Merck), plus <strong>LENVIMA<\/strong> (Lenvatinib; Eisai) for the treatment of patients with <a href=\"https:\/\/www.delveinsight.com\/report-store\/myelodysplastic-syndrome-market?utm_source=blog&amp;utm_medium=news&amp;utm_campaign=v\">advanced endometrial carcinoma<\/a> that was not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and who had disease progression following prior systemic therapy and were not candidates for curative surgery or radiation. This historic approval was based on a <strong>Phase II study<\/strong> (KEYNOTE-146\/Study 111) which marked the first-ever approval of an anti-PD-1 antibody in combination with a kinase inhibitor for the indication. As 25\u201330% of the patients with endometrial cancer have high MSI, there are still 70\u201375% of the patients without this mutation. The companies targeted the above patient pool and observed the objective response rate (ORR) of <strong>38.3%<\/strong>, with a complete response rate of <strong>10.6%<\/strong> (n = 10) and a partial response rate of <strong>27.7%<\/strong> with a tolerable safety profile. Back then, the US FDA announced that the continued approval for this indication would be contingent upon verification and description of clinical benefit in the confirmatory trial.<\/p>\n\n\n\n<p>Therefore, the company initiated a <strong>Phase III confirmatory trial<\/strong>, KEYNOTE-775\/Study-309 (NCT03517449), to evaluate the extended clinical benefit rate in the above patient population. In March 2021, the companies announced the positive results from the study, which indicated that the combination reduced the risk of death by <strong>38% <\/strong>compared with placebo,<strong> <\/strong>with a <strong>median overall survival (OS)<\/strong> of <strong>18.3 months <\/strong>vs. <strong>11.4 months<\/strong>, respectively. On the secondary endpoint of progression-free survival, the combination reduced the risk of disease progression or death by <strong>44%<\/strong> compared to placebo, with a median PFS in the two groups of <strong>7.2 months <\/strong>and <strong>3.8 months<\/strong>, respectively. The results come after Merck voluntarily withdrew another Keytruda approval as a second-line treatment for <a href=\"https:\/\/www.delveinsight.com\/blog\/small-cell-lung-cancer-market?utm_source=blog&amp;utm_medium=news&amp;utm_campaign=v\"><strong>small cell lung cancer (SCLC)<\/strong><\/a> after a confirmatory trial failed to prove a survival benefit.<\/p>\n\n\n\n<p>Based on the above topline data, the <strong>US FDA<\/strong> granted <strong>full approval<\/strong> for the combination in advanced dMMR\/MSI-H endometrial cancer in <strong>July 2021,<\/strong> following the priority review by the US FDA in May 2021. It seems as if Merck already had known that the deal with Eisai would work out well when they both signed an agreement for the worldwide co-development and co-commercialization of Lenvima in early 2018. Also, assuming the achievement of all development and commercial goals for <strong>all indications<\/strong> (six indications), the total amount of upfront, option, and regulatory and sales milestone payments can reach up to <strong>USD 5.76 billion,<\/strong> which would be shared equally by both the companies.<\/p>\n\n\n\n<p>Merck and Eisai also compare the <strong>first-line<\/strong> use of Keytruda\/Lenvima against chemotherapy in endometrial cancer in the <strong>LEAP-001<\/strong> trial that will read out in 2023. If approved, the combination could stand out in the first-line patient pool and rule the second-line pool with the non-dMMAR\/MSI-H patient pool.<\/p>\n\n\n\n<p>However, the combination is expected to face tough competition in renal cell carcinoma where the companies are trying out the combination in <strong>Phase III CLEAR trial (NCT02811861).<\/strong> Recently, the duo achieved the priority review from the US FDA to treat patients with advanced RCC receiving therapy in the frontline setting. The results were recently presented at <strong>ASCO 2021<\/strong>, which showed the clinical benefit of RCC patients and might pave its way to successful approval later this year. The other options in kidney cancer including Keytruda\u2019s pairing with Pfizer\u2019s Inlyta, Bristol Myers Squibb\u2019s combo of Opdivo and Yervoy, and an Opdivo pairing with Exelixis\u2019 Cabometyx.<\/p>\n\n\n\n<p>The above recent results of the combination prove that both the companies might generate a good market size in the upcoming years and might prove to be superior combinations with the highest prescription rates by the oncologists.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA Approves Keytruda in Both Adjuvant and Neoadjuvant Setting in High-Risk Early-Stage TNBC In July 2021, the US FDA approved pembrolizumab (Keytruda) for high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery. This approval was based on Phase III [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":13074,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[349,639,5789],"industry":[17225],"therapeutic_areas":[17228,17234],"class_list":["post-13070","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-latest-pharma-news","tag-pharma-news","tag-recent-pharma-news","industry-pharmaceutical","therapeutic_areas-oncology","therapeutic_areas-rare-diseases"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Merck\u2019s Keytruda | Abbvie\u2019s Venetoclax | Aprea&#039;s Eprenetapopt<\/title>\n<meta name=\"description\" content=\"Merck\u2019s Keytruda Approval; 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