{"id":17622,"date":"2022-06-14T20:38:35","date_gmt":"2022-06-14T15:08:35","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=17622"},"modified":"2022-06-14T21:01:56","modified_gmt":"2022-06-14T15:31:56","slug":"pharma-news-for-gsk-roche-owkin","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-gsk-roche-owkin","title":{"rendered":"GSK\u2019s RSV Vaccine Clears Phase III Test in Adults; Roche\u2019s Tecentriq for Adjuvant NSCLC; Owkin Bags $ 180 million from BMS; EU Approves Roche\u2019s Mosunetuzumab; Dostarlimab Elicits Clinical Complete Response in dMMR Rectal Cancer; FDA Backs Bluebird\u2019s CALD Gene Therapy; Takeda\u2019s Dengue Fever Vaccine TAK-003; FDA Approves Dupilumab"},"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-69f163b0eead6\" 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-69f163b0eead6\"  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-news-for-gsk-roche-owkin\/#GSK_Starts_Preparations_for_Regulatory_Filings_as_RSV_Vaccine_Clears_Phase_III_Test_in_Adults\" >GSK Starts Preparations for Regulatory Filings as RSV Vaccine Clears Phase III Test in Adults<\/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-news-for-gsk-roche-owkin\/#Roches_Tecentriq_Extends_Lead_Over_Keytruda_in_Adjuvant_NSCLC_Domain\" >Roche\u2019s Tecentriq Extends Lead Over Keytruda in Adjuvant NSCLC Domain<\/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-news-for-gsk-roche-owkin\/#Takeda_Reports_New_Positive_Data_for_Dengue_Fever_Vaccine_TAK-003\" >Takeda Reports New Positive Data for Dengue Fever Vaccine TAK-003<\/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-news-for-gsk-roche-owkin\/#FDA_Approves_Dupilumab_for_Children_6_Months_to_5_Years_of_Age_With_Atopic_Dermatitis\" >FDA Approves Dupilumab for Children 6 Months to 5 Years of Age With Atopic Dermatitis<\/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-news-for-gsk-roche-owkin\/#Owkin_Bags_USD_180_million_Alliance_from_BMS_for_Cardiovascular_Clinical_Trials\" >Owkin Bags USD 180 million Alliance from BMS for Cardiovascular Clinical Trials<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-gsk-roche-owkin\/#Roche_Secures_First_EU_Approval_for_Mosunetuzumab_for_Follicular_Lymphoma_Treatment\" >Roche Secures First EU Approval for Mosunetuzumab for Follicular Lymphoma Treatment<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-gsk-roche-owkin\/#100_Clinical_Response_Rate_in_all_dMMR_Rectal_Cancer_Patients_With_Neoadjuvant_PD-1_Inhibition\" >100% Clinical Response Rate in all dMMR Rectal Cancer Patients With Neoadjuvant PD-1 Inhibition<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-gsk-roche-owkin\/#FDA_Backs_Bluebirds_CALD_Gene_Therapy_Despite_Safety_Worries\" >FDA Backs Bluebird\u2019s CALD Gene Therapy, Despite Safety Worries<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-gsk-starts-preparations-for-regulatory-filings-as-rsv-vaccine-clears-phase-iii-test-in-adults\"><span class=\"ez-toc-section\" id=\"GSK_Starts_Preparations_for_Regulatory_Filings_as_RSV_Vaccine_Clears_Phase_III_Test_in_Adults\"><\/span><strong>GSK Starts Preparations for Regulatory Filings as RSV Vaccine Clears Phase III Test in Adults<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>GSK<\/strong> plans to initiate preparation for regulatory submissions for its <strong>respiratory syncytial virus (RSV) vaccine<\/strong> after the vaccine performed well in the much-anticipated <strong>AReSVi 006 trial<\/strong> in individuals aged 60 and above.&nbsp;<\/p>\n\n\n\n<p>&nbsp;According to the company, the <strong>RSVPreF3 OA<\/strong> vaccine demonstrated \u201cstatistically substantial and clinically important\u201d efficacy in this scenario, with consistent action across RSV A and B strains and in older age groups, including those aged &gt;70. The findings are comparable with in-house findings from a parallel <strong>Phase III trial (AReSVi 004)<\/strong>, which discovered that RSV-directed antibodies persist for at least 6 months after immunization. GSK now hopes to begin regulatory filings for the vaccine in the second half of 2022, intending to bring it to market ahead of rival jabs from <strong>Pfizer, Johnson &amp; Johnson, Bavarian Nordic, and Moderna.&nbsp;<\/strong><\/p>\n\n\n\n<p>The pharma group also claims that there were no safety concerns with RSVPreF3 OA in the trial, which is significant given that the company was forced to pause injection trials in pregnant moms earlier this year while it evaluated a possible safety risk. However, the adult population represents a significantly larger market for a prospective <a href=\"https:\/\/www.delveinsight.com\/report-store\/respiratory-syncytial-virus-rsv-pipeline-insight\">RSV vaccine<\/a>, accounting for the majority of GSK\u2019s predicted <strong>USD 4 billion<\/strong> in peak sales for its jab. GSK must move swiftly to stay on top of its competitors, particularly <strong>Pfizer<\/strong>, which will release the results of its vaccine\u2019s <strong>Phase III RENOIR<\/strong> study very shortly.<\/p>\n\n\n\n<p>Meanwhile, <strong>J&amp;J<\/strong> began its <strong>Phase III EVERGREEN study<\/strong> in September, with results expected in 2023, while Bavarian Nordic and Moderna candidates have also entered the last stage of clinical testing. Furthermore, <strong>Moderna<\/strong> has stated that it expects to proceed with a proposal to combine flu, COVID-19, and RSV into a single shot, potentially disrupting the first generation of <a href=\"https:\/\/www.delveinsight.com\/report-store\/respiratory-syncytial-virus-rsv-market\">RVS-only vaccines market<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Roches_Tecentriq_Extends_Lead_Over_Keytruda_in_Adjuvant_NSCLC_Domain\"><\/span><strong>Roche\u2019s Tecentriq Extends Lead Over Keytruda in Adjuvant NSCLC Domain<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>While <strong>Merck &amp; Co\u2019s Keytruda<\/strong> is the clear leader in the non-small cell lung cancer (NSCLC) category, there is one category where it falls short of <strong>Roche\u2019s Tecentriq<\/strong> \u2013 treatment of early-stage cases curable with surgery. Roche gained FDA clearance for Tecentriq (atezolizumab) as an adjuvant for certain <a href=\"https:\/\/www.delveinsight.com\/report-store\/non-small-cell-lung-cancer-nsclc-market\">NSCLC patients<\/a> last year and has now received European Commission approval for this indication, solidifying its position. Tecentriq has been approved for use after surgery and platinum-based chemotherapy for NSCLC \u2013 in patients with tumors expressing 1% or more of the PD-L1 biomarker \u2013 to try to prevent the disease from reoccurring.<\/p>\n\n\n\n<p>The EU approval is based on the findings of the <strong>IMpower010 study<\/strong>, which showed that Tecentriq improved disease-free survival by <strong>34%<\/strong> overall when used after initial surgery and chemo for PD-L1-positive NSCLC patients compared to supportive care, and by <strong>57%<\/strong> in patients with high (<strong>50%<\/strong> or higher) levels of the biomarker. Roche has a window of opportunity to grow Tecentriq in adjuvant NSCLC unopposed. However, the opening may be short-lived since Merck now has results from the <strong>KEYNOTE-091 trial<\/strong> for Keytruda in these patients, which included an all-comer NSCLC population regardless of PD-L1 expression levels. It also included a slightly broader spectrum of NSCLC patients in stages Ib\u2013IIIa versus stage II\u2013IIIa in IMpower010.<\/p>\n\n\n\n<p>Other cancer immunotherapy developers are also doing adjuvant <a href=\"https:\/\/www.delveinsight.com\/report-store\/non-small-cell-lung-cancer-nsclc-pipeline-insight\">NSCLC studies<\/a>, and while the results are still months away, they may help oncologists better to grasp the function of immunotherapy in adjuvant NSCLC.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Takeda_Reports_New_Positive_Data_for_Dengue_Fever_Vaccine_TAK-003\"><\/span><strong>Takeda Reports New Positive Data for Dengue Fever Vaccine TAK-003<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Takeda declared that its dengue vaccine candidate, <strong>TAK-003<\/strong>, prevented <strong>84%<\/strong> of hospitalized dengue cases and <strong>61%<\/strong> of symptomatic <a href=\"https:\/\/www.delveinsight.com\/report-store\/dengue-pipeline-insight\">dengue cases<\/a>, with no vital safety risks identified, in the overall population, including both seropositive and seronegative individuals through 4\u00bd years after vaccination in the pivotal <strong>Phase III Tetravalent Immunization against Dengue Efficacy Study trial<\/strong>.<\/p>\n\n\n\n<p>Through 4\u00bd years, TAK-003 showed <strong>84.1%<\/strong> vaccine efficacy against hospitalized dengue, with <strong>85.9%<\/strong> vaccine efficacy in seropositive individuals and <strong>79.3%<\/strong> vaccine efficacy in seronegative individuals. TAK-003 also demonstrated overall vaccine efficacy of<strong> 61.2%<\/strong> against <strong>virologically-confirmed dengue (VCD)<\/strong>, with <strong>64.2%<\/strong> vaccine efficacy in seropositive individuals and <strong>53.5% <\/strong>vaccine efficacy in seronegative individuals. Observations of vaccine efficacy varied by serotype and remained consistent with previously reported results. TAK-003 was generally well-tolerated, and no critical safety risks were recognized. No indication of disease enhancement was detected throughout the 54-month follow-up exploratory analysis.<\/p>\n\n\n\n<p>These new long-term results supplement previously published TIDES trial data that showed the candidate vaccine met its primary endpoint of overall vaccine efficacy against virologically-confirmed dengue, with <strong>80.2%<\/strong> efficacy at 12-months follow-up, as well as all secondary endpoints for which there were a sufficient number of <a href=\"https:\/\/www.delveinsight.com\/report-store\/dengue-fever-pipeline-insight\">dengue fever cases<\/a> at 18-months follow-up, including <strong>90.4%<\/strong> vaccine efficacy against hospitalized dengue. While the long-term follow-up for the primary two-dose series has been completed, the TIDES trial remains ongoing to evaluate the safety and effectiveness of a booster dose. The TIDES trial is Takeda\u2019s largest interventional clinical trial, enrolling more than 20,000 healthy children and adolescents (4\u201316 years of age), across eight dengue-endemic countries, over the past 4\u00bd years.<\/p>\n\n\n\n<p>TAK-003 is undergoing regulatory trials to prevent dengue disease in children and adults in the European Union and select dengue-endemic countries.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Dupilumab_for_Children_6_Months_to_5_Years_of_Age_With_Atopic_Dermatitis\"><\/span><strong>FDA Approves Dupilumab for Children 6 Months to 5 Years of Age With Atopic Dermatitis<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The US Food and Drug Administration approved <a href=\"https:\/\/www.delveinsight.com\/blog\/dupixent-market\"><strong>Dupixent<\/strong><\/a> for children (aged 6 months to 5 years) suffering from <a href=\"https:\/\/www.delveinsight.com\/report-store\/moderate-to-severe-atopic-dermatitis-market\"><strong>moderate-to-severe atopic dermatitis<\/strong><\/a> whose disease is not sufficiently controlled with topical prescription therapies. A regulatory filing for the mentioned age group is under inspection by the <strong>European Medicines Agency<\/strong>, and submissions to regulatory authorities in additional countries are in process.<\/p>\n\n\n\n<p><a href=\"https:\/\/www.delveinsight.com\/report-store\/atopic-dermatitis-market\"><strong>Atopic dermatitis<\/strong><\/a> is a <strong>chronic type II inflammatory skin disease<\/strong>. Eighty-five to ninety percent of patients develop symptoms before age 5, which can continue through adulthood. Symptoms include intense, persistent itch and skin lesions covering much of the body, resulting in skin dryness, cracking, pain, redness or darkening, crusting and oozing, and an increased risk of skin infections. In the United States, more than 75,000 children aged 5 and younger have uncontrolled moderate-to-severe atopic dermatitis and are most in need of new treatment options.<\/p>\n\n\n\n<p>The FDA accessed Dupixent under Priority Review, which is reserved for drugs that significantly improve efficacy or safety in treating severe conditions. The approval is established on data that include a <strong>Phase III trial<\/strong> evaluating Dupixent every 4 weeks plus low-potency topical corticosteroids or topical corticosteroids alone. The trial met the primary and secondary endpoints. At 4 months, patients who received Dupixent with topical corticosteroids experienced the following, compared to TCS alone:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Twenty-eight percent<\/strong> of patients achieved clear or almost clear skin compared to <strong>4%<\/strong> with placebo, the primary endpoint.<\/li><li><strong>Fifty-three percent<\/strong> achieved <strong>75%<\/strong> or more significant improvement in disease severity from baseline compared to <strong>11%<\/strong> with placebo topical corticosteroids alone, the co-primary endpoint outside the US.<\/li><li><strong>Forty-eight percent<\/strong> achieved a clinically meaningful reduction in itch compared to <strong>9%<\/strong> with placebo.<\/li><\/ul>\n\n\n\n<p>The safety profile of Dupixent observed through 4 months in children aged 6 months to 5 years was similar to the safety profile in patients aged \u22656. The long-term safety profile of Dupixent in children aged 6 months to 5 years through 52 weeks was also similar to the safety profile observed in the pivotal trial and consistent with that observed in older patients with atopic dermatitis. Hand-foot-and-mouth disease and skin papilloma were reported in 5% and 2% of Dupixent patients aged 6 months to 5 years, and none of these cases were directed to discontinuation of treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Owkin_Bags_USD_180_million_Alliance_from_BMS_for_Cardiovascular_Clinical_Trials\"><\/span><strong>Owkin Bags USD 180 million Alliance from BMS for Cardiovascular Clinical Trials<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In one of the latest commercial updates in the pharmaceutical domain, the <strong>Bristol Myers Squibb<\/strong> has signed a deal with <strong>Owkin <\/strong>to utilize <strong>Owkin\u2019s artificial intelligence<\/strong> capabilities to carry out more targeted and efficient clinical trials. The <a href=\"https:\/\/www.delveinsight.com\/blog\/artificial-intelligence-in-drug-discovery\">artificial intelligence-powered clinical development platform<\/a> is intended to cover a wide range of therapeutic candidates for hard-to-treat diseases.<\/p>\n\n\n\n<p>As per the deal, <strong>Bristol-Myers Squibb <\/strong>will pay <strong>USD 80 million<\/strong> upfront to tap into its expertise. The Owkin will also receive a\u00a0 <strong>BMS\u2019 Series B-1 equity investment <\/strong>and will further receive USD 100 million or more depending on landmarks gained in the current agreement. As per the deal, the companies will focus on improving clinical trial outcomes and identifying biomarkers that can be used to target specific patient subgroups and define the endpoint measures. Both companies intend to find <a href=\"https:\/\/www.delveinsight.com\/blog\/upcoming-cardiovascular-drugs\">therapies for cardiovascular diseases<\/a> but utilize AI in other therapeutic areas later. The companies are also expected to disclose further information in the coming months.<\/p>\n\n\n\n<p>A few months back, Owkin agreed to a <strong>USD 270 million<\/strong> cancer-focused alliance with Sanofi that has assisted the company\u2019s valuation to touch the USD 1 billion threshold and landed it into the unicorn category.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Roche_Secures_First_EU_Approval_for_Mosunetuzumab_for_Follicular_Lymphoma_Treatment\"><\/span><strong>Roche<\/strong> <strong>Secures First EU Approval for Mosunetuzumab for Follicular Lymphoma Treatment<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Roche <\/strong>has received conditional marketing authorization from the <strong>European Commission (EC) <\/strong>for its <a href=\"https:\/\/www.delveinsight.com\/report-store\/follicular-lymphoma-market-insights\"><strong>relapsed or refractory (R\/R) follicular lymphoma (FL)<\/strong> <strong>therapy<\/strong><\/a>, <strong>Lunsumio (mosunetuzumab)<\/strong>. Mosunetuzumab is a first-in-class <strong>CD20xCD3 <\/strong>T-cell engaging bispecific antibody for adult patients.<\/p>\n\n\n\n<p>The European Commission has approved mosunetuzumab under the <strong>Lunsumio <\/strong>trade name for R\/R FL. The results of <strong>Phase I\/II study of mosunetuzumab<\/strong> have formed the basis for the EU to give the regulatory nod. In&nbsp;Phase I\/II study, mosunetuzumab demonstrated a complete response rate of <strong>60%<\/strong> and a median progression-free survival of around <strong>18 months<\/strong> when used as a third-line or later therapy. Additionally, the therapy had favorable tolerability in people with heavily pre-treated FL.<\/p>\n\n\n\n<p>Follicular Lymphoma (FL) is one of the most common slow-growing forms of <a href=\"https:\/\/www.delveinsight.com\/report-store\/non-hodgkins-lymphoma-market\">non-Hodgkin\u2019s lymphoma<\/a>. In Europe, nearly <strong>28,000 people<\/strong> are diagnosed with FL each year. The launch of the mosunetuzumab is expected to improve the overall <a href=\"https:\/\/www.delveinsight.com\/report-store\/follicular-lymphoma-pipeline-insight\">treatment scenario of FL<\/a> in the coming years.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"100_Clinical_Response_Rate_in_all_dMMR_Rectal_Cancer_Patients_With_Neoadjuvant_PD-1_Inhibition\"><\/span><strong>100% Clinical Response Rate in all dMMR Rectal Cancer Patients With Neoadjuvant PD-1 Inhibition<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A <a href=\"https:\/\/www.delveinsight.com\/asco-conference\/article\/dostarlimab-rectal-cancer\"><strong>single-agent dostarlimab-gxly (Jemperli)<\/strong><\/a> executed a clinical response rate (cCR) of 100% in a small group of patients, i.e., 14 people, suffering from<strong> stage II\/III locally advanced mismatch repair-deficient (dMMR) rectal cancer<\/strong>, allowing them to avoid chemotherapy, radiation therapy, and surgery at least for the time being.<\/p>\n\n\n\n<p>All <strong>14 patients<\/strong> followed for almost <strong>6 months<\/strong> had complete clinical responses with no evidence of tumor on follow-up MRI. Follow-ups in the cohort ranged from <strong>6 to 25 months<\/strong>, and no patient was reported to have received additional therapy. Four other patients with limited follow-up have preliminary evidence of response, including one clinical complete response. This 6-month course of the PD-1 inhibitor was observed to be well-tolerated, as presented by Andrea Cercek, MD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York City at the <a href=\"https:\/\/www.delveinsight.com\/asco-conference-2022\">American Society of Clinical Oncology (ASCO) <\/a>annual meeting. The study was presented in the New England Journal of Medicine.<\/p>\n\n\n\n<p>\u201cWe observed 100% complete response in the first 14 consecutive patients,\u201d said Cercek. \u201cWe noted no grade 3 or 4 adverse events. No patients have required chemotherapy, radiation, or surgery. There has been no disease recurrence during the follow-up period. Longer follow-up is certainly required to establish the durability of this treatment.\u201d<\/p>\n\n\n\n<p>It is noted that almost <strong>5\u201310%<\/strong> of every rectal cancer is reported to be dMMR, which results in resistance to chemotherapy. Investigators hypothesized that <strong>PD-1 blockade<\/strong> might replace chemotherapy, chemotherapy plus radiation, or replace the trimodality approach of chemotherapy, radiation, and surgery. These 14 patients received <a href=\"https:\/\/www.delveinsight.com\/asco-conference\/article\/dostarlimab-rectal-cancer\">PD-1 monoclonal antibody dostarlimab<\/a> at a dosage of 500 mg intravenously <strong>every 3 weeks for 6 months, equaling nine total cycles.<\/strong> At baseline and through treatment, patients were closely monitored and assessed for response at <strong>6 weeks, 3 months, and 6 months. <\/strong>At the end of 6 months, a cCR was defined as no evidence of residual tumor on both the digital and endoscopic rectal exams and on the rectal MRI results.&nbsp;<\/p>\n\n\n\n<p>With high hopes of being a beneficial treatment in rectal cancer, dostarlimab was approved by the FDA in<strong> August 2021<\/strong> for the treatment of patients with dMMR recurrent or <a href=\"https:\/\/www.delveinsight.com\/blog\/oncology\/page\/50\">advanced solid tumors<\/a> who have progressed on or following prior therapy and who have no satisfactory treatment options.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Backs_Bluebirds_CALD_Gene_Therapy_Despite_Safety_Worries\"><\/span><strong>FDA Backs Bluebird\u2019s CALD Gene Therapy, Despite Safety Worries<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The US FDA seems to have safety concerns about <strong>Bluebird Bio\u2019s gene therapy<\/strong> for the rare, fatal <a href=\"https:\/\/www.delveinsight.com\/report-store\/cerebral-adrenoleukodystrophy-cald-market\"><strong>cerebral adrenoleukodystrophy (CALD)<\/strong><\/a>. However, the FDA\u2019s advisors and panel members believe its benefits can outnumber the risks. Agency\u2019s Cellular, Tissue, and Gene Therapies advisory committee members voted a <strong>15 to 0 <\/strong>in favor of the approval of<strong> <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/lenti-d-emerging-drug-insight-and-market-forecast\"><strong>elivaldogene autotemcel \u2013 aka eli-cel and Lenti-D<\/strong><\/a> \u2013 before the FDA\u2019s scheduled decision on the drug this September.<\/p>\n\n\n\n<p>The FDA reviewers mentioned in the briefing documents that several cases of <a href=\"https:\/\/www.delveinsight.com\/report-store\/myelodysplastic-syndrome-market\"><strong>myelodysplastic syndrome (MDS)<\/strong><\/a> were found in <strong>4% of children<\/strong> treated with eli-cel, leading to speculation that the panel may have taken a more guarded stance on the therapy. A vote was also formed for the safety data of the therapy, where panelists asked to consider whether data on another of bluebird\u2019s gene therapies called lovo-cel had a bearing on the eli-cel deliberations. Thirteen of them said no, with one abstention and one vote to the contrary.<\/p>\n\n\n\n<p>The main factor that most advisors considered is an overwhelming need for a new treatment option for CALD, a devastating disease caused by mutations in the<strong> <\/strong><a href=\"https:\/\/www.delveinsight.com\/blog\/adrenoleukodystrophy-market-size\"><strong>ABCD1 gene<\/strong><\/a><strong>,<\/strong> which allows<strong> very-long-chain fatty acids (VLCFAs)<\/strong> to accumulate in the central nervous system, causing severe nerve damage. Eli-cel is designed to upregulate a gene that is very similar to<strong> ABCD1 \u2013 called ABCD2<\/strong> \u2013 and can compensate for the enzyme deficiency caused by the mutation. The drug has been previously approved in Europe with the name <strong>Skysona<\/strong>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>GSK Starts Preparations for Regulatory Filings as RSV Vaccine Clears Phase III Test in Adults GSK plans to initiate preparation for regulatory submissions for its respiratory syncytial virus (RSV) vaccine after the vaccine performed well in the much-anticipated AReSVi 006 trial in individuals aged 60 and above.&nbsp; &nbsp;According to the company, the RSVPreF3 OA vaccine [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":17625,"comment_status":"closed","ping_status":"closed","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":[7478,143,17975,19416,19414,18834,2831,1111,19415,17615],"industry":[17225],"therapeutic_areas":[17242,17237,17227,17245,17228,17243],"class_list":["post-17622","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-atopic-dermatitis","tag-cardiovascular-disease","tag-cardiovascular-diseases","tag-cerebral-adrenoleukodystrophy","tag-dengue-fever","tag-follicular-lymphoma","tag-non-hodgkin-lymphoma","tag-nsclc","tag-rectal-cancer","tag-respiratory-syncytial-virus","industry-pharmaceutical","therapeutic_areas-cardiovascular-diseases","therapeutic_areas-dermatology","therapeutic_areas-immunological-and-autoimmune-disorders","therapeutic_areas-neurology","therapeutic_areas-oncology","therapeutic_areas-respiratory-diseases"],"acf":[],"yoast_head":"<!-- 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