On March 7, 2022 Akeso, Inc. (9926.HK) ("Akeso"), a biopharmaceutical company dedicated to the development of innovative antibody drugs, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved the IND application for the initiation of the open-label, multicenter phase II trial in China using Cadonilimab (PD-1/CTLA-4 bispecific antibody, AK104) in combination with Docetaxel in patients with advanced NSCLC which progressed on combination therapy of PD-1/L1 inhibitor and platinum-based doublet chemotherapy (Press release, Akeso Biopharma, MAR 7, 2022, View Source [SID1234609614]).

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PD-1/L1 inhibitor plus chemotherapy serves as the first-line treatment for patients with advanced NSCLC. However, more than 70% of patients have progressed one year following the therapy. The current standard treatment for progressive advanced NSCLC is Docetaxel, which the reported progression-free survival (PFS) was approximately 4 months, and overall survival (OS) was approximately 10 months. A new therapeutic approach is needed to improve the prognosis of patients.

Cadonilimab is a bi-specific antibody with dual blockade of both PD-1 and CTLA-4. By combining with Docetaxel, this combo strategy may reduce the risk of delayed efficacy and pseudoprogression and may benefit patients with advanced NSCLC following PD-1/L1 inhibitor and platinum-based doublet chemotherapy.

On March 7, 2022 Flamingo Therapeutics., a biotechnology company pioneering RNA-targeting therapies in oncology, reported that Mike Garrett, Chief Executive Officer, will present at the BioCapital Europe 2022 meeting on March 10th, 2022 at 5pm CET/11am ET (Press release, Flamingo Therapeutics, MAR 7, 2022, View Source;utm_medium=rss&utm_campaign=flamingo-therapeutics-to-present-at-biocapital-europe-2022 [SID1234609578]). The Flamingo management team will also participate in one-on-one meetings with investors during the conference. BioCapital Europe will be taking place in person at Hotel Sofitel Legend The Grand Amsterdam.

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BioCapital Europe is Europe’s premier life sciences investment conference, offering VCs and Institutional Investors unique and timely access to around 40 exciting biotech, medtech and diagnostics companies from the Benelux and Europe.

On March 7, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported the presentation of findings from a collaborative study with Tempus investigating the prevalence of Class II and Class III alterations among patients with BRAF-mutated solid tumors (Press release, Kinnate Biopharma, MAR 7, 2022, View Source [SID1234609596]). These findings were presented as an e-Poster at the virtual European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Targeted Anticancer Therapies Congress (TAT), taking place March 7-9, 2022.

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"Advances in genomic profiling have significantly increased our ability to define emerging patient populations, and enable the development of effective targeted therapies for patients who do not currently benefit from precision medicine approaches," said Richard Williams, MBBS, Ph.D., Chief Medical Officer at Kinnate. "Through our collaboration with Tempus, and other leading precision medicine companies, we have found that there is a substantial number of cancer patients with BRAF Class II or Class III alterations, none of whom have access to approved targeted cancer therapies. We appreciate the opportunity to share insights on this urgent unmet need with the clinical research community gathered for the ESMO (Free ESMO Whitepaper) TAT 2022 conference."

This study utilized a de-identified clinico-genomic database of more than 55,000 cancer patients whose tumors were profiled using the Tempus xT next generation sequencing assay, a 648-gene DNA panel coupled with transcriptome RNA sequencing. A cohort of more than 1,100 patients was identified with BRAF Class II or Class III oncogenic alterations representing approximately 2% of patients. Among the patients with BRAF Class II or Class III alterations, those diagnosed with melanoma or non-small cell lung cancer (NSCLC) were most commonly treated with immunotherapy or chemotherapy +/- immunotherapy, respectively. At least 70% of patients with BRAF alterations had stage IV (metastatic) disease, and the distribution of cancer stages was similar across BRAF classes. Compared to BRAF Class I alterations, BRAF Class II and Class III alterations were more likely to co-occur with other gene alterations in the MAPK pathway such as NRAS, KRAS and NF1. Within the NSCLC and melanoma cohort, tumors with BRAF Class II or Class III alterations had a higher tumor mutation burden (TMB) than BRAF wild-type tumors. Additionally, patients with NSCLC and Class II or Class III alterations experienced shorter time to treatment discontinuation in first line and second line of therapy compared to patients with NSCLC and BRAF Class I alterations which is suggestive of inferior treatment outcomes.

"These findings are of particular interest given that BRAF Class II and Class III alterations are prevalent oncogenic drivers with no approved targeted therapy. Tumors with BRAF Class II or Class III alterations have been shown to be associated with unique tumor characteristics, including higher TMB and more frequent co-occurrence with other MAPK pathway alterations. Our real-world data study indicates that patients with NSCLC and BRAF Class II or Class III alterations experience shorter time to treatment discontinuation relative to patients with NSCLC and BRAF Class I alterations," said Paul Severson, Ph.D., Senior Director of Translational Medicine and Bioinformatics at Kinnate.

The e-Poster (Presentation #40P), titled "Real-World Clinical Genomic Analysis of Patients with BRAF Mutated Cancers Identifies BRAF Class II and III as a Population of Unmet Medical Need," will be presented by Dr. Severson and is available to registered attendees for on-demand viewing at: www.esmo.org/meetings/esmo-tat-2022.

On March 7, 2022 Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for TIBSOVO (ivosidenib tablets) as a potential treatment for patients with previously untreated IDH1-mutated acute myeloid leukemia (AML) (Press release, Servier, MAR 7, 2022, View Source [SID1234609615]). The sNDA was granted Priority Review, which accelerates the review and shortens the review time goal from 10 months to 6 months. Priority Review is typically given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists.

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"On the heels of our recent FDA approval of TIBSOVO in cholangiocarcinoma, we are pleased with this important step forward in the agency’s consideration to expand its current indication to include the treatment of patients with previously untreated IDH1-mutated acute myeloid leukemia," said David K. Lee, Chief Executive Officer, Servier Pharmaceuticals. "We are thrilled with the positive momentum of this program as we continue to grow our leadership in oncology and deliver more life-changing medicines to patients living with difficult-to-treat cancers."

The sNDA acceptance is supported by results from the AGILE study, a global, Phase 3 trial in patients with previously untreated IDH1-mutated AML, which were presented at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. The data demonstrated that treatment with TIBSOVO in combination with azacitidine significantly improved event-free survival (EFS) (hazard ratio [HR] = 0.33, 95% CI 0.16, 0.69, 1-sided P = 0.0011 1,2). In addition, the combination of TIBSOVO with azacitidine showed a statistically significant improvement in overall survival (OS) (HR = 0.44 [95% CI 0.27, 0.73]; 1-sided P = 0.0005), with a median OS of 24.0 months.

"TIBSOVO is the first therapy targeting cancer metabolism to demonstrate improved event-free survival and overall survival in combination with azacitidine in patients with previously untreated IDH1-mutated AML," said Susan Pandya, M.D., Vice President Clinical Development and Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier Pharmaceuticals. "With this FDA acceptance for Priority Review, we are closer to offering this critical treatment option to patients in the U.S. and we look forward to engaging with regulatory agencies around the world."

TIBSOVO[*] is currently approved in the U.S. as monotherapy for the treatment of adults with IDH1-mutant relapsed or refractory acute myeloid leukemia (AML), and for adults with newly diagnosed IDH1-mutant AML who are ≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. Recently, TIBSOVO was approved as a first and only targeted therapy for patients with previously treated IDH1-mutated cholangiocarcinoma.

In an effort to bring innovative treatment options to patients living with difficult-to-treat cancers, Servier has made oncology a priority globally, and allocates more than 50% of its research and development budget to cancer research. With more than 21 oncology assets at varying stages of clinical development, and 20 research projects ongoing, Servier is committed to finding solutions that address patient needs across the entire spectrum of disease and in a variety of tumor types.

About the NCT03173248 AGILE Phase 3 AML Trial

The AGILE trial is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial designed to evaluate the efficacy and safety of TIBSOVO in combination with azacitidine compared with placebo in combination with azacitidine, in adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) who are not candidates for intensive chemotherapy (≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy). The study’s primary endpoint is EFS, defined as the time from randomization until treatment failure, relapse from remission, or death from any cause, whichever occurs first. Treatment failure is defined as failure to achieve complete remission (CR) by Week 24.

Key secondary endpoints included CR rate, defined as the proportion of participants who achieve a CR; overall survival (OS), defined as the time from date of randomization to the date of death due to any cause; CR and complete remission with partial hematologic recovery (CRh) rate, defined as the proportion of participants who achieve a CR or CRh; and objective response rate (ORR), defined as the rate of CR, CR with incomplete hematologic recovery (CRi) (including CR with incomplete platelet recovery [CRp]), partial remission (PR), and morphologic leukemia-free state (MLFS).

About Acute Myeloid Leukemia
Acute myeloid leukemia (AML) a cancer of blood and bone marrow characterized by rapid disease progression, is the most common acute leukemia affecting adults, with approximately 20,000 new cases in the U.S., and 43,000 cases in Europe each year.1,2,7 AML incidence significantly increases with age, and the median age of diagnosis is 68.1 The vast majority of patients do not respond to chemotherapy and progress to relapsed/refractory AML.3 The five-year survival rate is approximately 29.5%.1 For 6 to 10 percent of AML patients, the mutated IDH1 enzyme blocks normal blood stem cell differentiation, contributing to the genesis of acute leukemia.4

On March 7, 2022 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that LENVIMA (generic name: lenvatinib mesylate), the multiple receptor tyrosine kinase inhibitor discovered by Eisai, in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada)’s KEYTRUDA (generic name: pembrolizumab) has been approved in Taiwan for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation (Press release, Eisai, MAR 7, 2022, View Source [SID1234609544]).

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The approval is based on results from the pivotal Phase 3 Study 309/KEYNOTE-775 trial. These results were presented at the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women’s Cancer in March 2021, and published in the New England Journal of Medicine in January 2022.1 In this trial, LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 38% (HR=0.62 [95% CI, 0.51-0.75]; p<0.0001), and progression-free survival (PFS), reducing the risk of disease progression or death by 44% (HR=0.56 [95% CI, 0.47-0.66]; p<0.0001), versus chemotherapy (investigator’s choice of doxorubicin or paclitaxel). The median OS was 18.3 months for LENVIMA plus KEYTRUDA versus 11.4 months for chemotherapy. The median PFS was 7.2 months for LENVIMA plus KEYTRUDA versus 3.8 months for chemotherapy. The objective response rate (ORR) was 32% (95% CI, 27-37) for patients treated with LENVIMA plus KEYTRUDA versus 15% (95% CI, 11-18) for patients treated with chemotherapy (p<0.0001). Patients treated with LENVIMA plus KEYTRUDA achieved a complete response (CR) rate of 7% and partial response (PR) rate of 25% versus a CR rate of 3% and a PR rate of 12% for patients treated with chemotherapy.2 In this trial, the five most common adverse reactions (any grade) observed in the LENVIMA plus KEYTRUDA combination arm were hypothyroidism, hypertension, fatigue, diarrhea and musculoskeletal disorders.2

LENVIMA plus KEYTRUDA was previously approved under accelerated approval process in Taiwan, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation based on data from the Study 111/KEYNOTE-146 trial. In accordance with accelerated approval regulations, continued approval was contingent upon verification and description of clinical benefit; these accelerated approval requirements have been fulfilled with the data from Study 309/KEYNOTE-775.

Endometrial cancer is the most common type of uterine body cancer. It is considered that more than 90% of uterine body cancers occur in the endometrium.3 Worldwide, it was estimated there were more than 417,000 new cases and more than 97,000 deaths from uterine body cancers in 2020.4 In Taiwan, there were more than 2,700 new cases of uterine body cancer and nearly 400 deaths from the disease in 2018.5 The five-year relative survival rate for metastatic endometrial cancer (stage IV) is estimated to be approximately 17%.6

Eisai positions oncology as a key therapeutic area and is aiming to discover innovative new medicines with the potential to cure cancer. Eisai is committed to expanding the potential clinical benefits of lenvatinib for cancer treatment, as it seeks to contribute to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families and healthcare professionals.

*In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with the anti-PD-1 therapy pembrolizumab from Merck & Co., Inc., Kenilworth, N.J., U.S.A.