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Genmab and ADC Therapeutics Announce Amended Agreement for Camidanlumab Tesirine (Cami)
Genmab and ADC Therapeutics Announce Amended Agreement for Camidanlumab Tesirine (Cami) Media Release Copenhagen, Denmark and Lausanne, Switzerland, October 30, 2020 • ADC Therapeutics to continue the development and commercialization of Cami • Genmab to receive mid-to-high single-digit tiered royalty Genmab A/S (Nasdaq: GMAB) and ADC Therapeutics SA (NYSE: ADCT) today announced that they have executed an amended agreement for ADC Therapeutics to continue the development and commercialization of camidanlumab tesirine (Cami). The parties first entered into a collaboration and license agreement in June 2013 for the development of Cami, an antibody drug conjugate (ADC) which combines Genmab’s HuMax®-TAC antibody targeting CD25 with ADC Therapeutics’ highly potent pyrrolobenzodiazepine (PBD) warhead technology. Under the terms of the 2013 agreement, the parties were to determine the path forward for continued development and commercialization of Cami upon completion of a Phase 1a/b clinical trial. ADC Therapeutics previously announced that Cami achieved an overall response rate of 86.5%, including a complete response rate of 48.6%, in Hodgkin lymphoma patients in this trial who had received a median of five prior lines of therapy. Cami is currently being evaluated in a 100-patient pivotal Phase 2 clinical trial intended to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). The trial is more than 50 percent enrolled and ADC Therapeutics anticipates reporting interim results in the first half of 2021. “We have a long-standing relationship with the ADC Therapeutics team and believe they are an ideal partner for the ongoing development and potential commercialization of Cami,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. -
ADC Therapeutics SA (Exact Name of Registrant As Specified in Its Charter)
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of February 2021. Commission File Number: 001-39071 ADC Therapeutics SA (Exact name of registrant as specified in its charter) Biopôle Route de la Corniche 3B 1066 Epalinges Switzerland (Address of principal executive office) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F: Form 20-F ☒ Form 40-F Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐ Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐ SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. ADC Therapeutics SA Date: February 4, 2021 By: /s/ Michael Forer Name: Michael Forer Title: Executive Vice President & General Counsel EXHIBIT INDEX Exhibit No. Description 99.1 Press release dated February 4, 2021 Exhibit 99.1 ADC Therapeutics Completes Enrollment in Pivotal Phase 2 Clinical Trial of Camidanlumab Tesirine (Cami) in Relapsed or Refractory Hodgkin Lymphoma Interim results anticipated in the first half of 2021 LAUSANNE, Switzerland, February 4, 2021 – ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, today announced completion of enrollment in the pivotal Phase 2 clinical trial evaluating the efficacy and safety of camidanlumab tesirine (Cami, formerly ADCT-301) in patients with relapsed or refractory Hodgkin lymphoma. -
Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients
antibodies Review Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients Andrew T. Lucas 1,2,3,*, Ryan Robinson 3, Allison N. Schorzman 2, Joseph A. Piscitelli 1, Juan F. Razo 1 and William C. Zamboni 1,2,3 1 University of North Carolina (UNC), Eshelman School of Pharmacy, Chapel Hill, NC 27599, USA; [email protected] (J.A.P.); [email protected] (J.F.R.); [email protected] (W.C.Z.) 2 Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] 3 Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] * Correspondence: [email protected]; Tel.: +1-919-966-5242; Fax: +1-919-966-5863 Received: 30 November 2018; Accepted: 22 December 2018; Published: 1 January 2019 Abstract: The rapid advancement in the development of therapeutic proteins, including monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), has created a novel mechanism to selectively deliver highly potent cytotoxic agents in the treatment of cancer. These agents provide numerous benefits compared to traditional small molecule drugs, though their clinical use still requires optimization. The pharmacology of mAbs/ADCs is complex and because ADCs are comprised of multiple components, individual agent characteristics and patient variables can affect their disposition. To further improve the clinical use and rational development of these agents, it is imperative to comprehend the complex mechanisms employed by antibody-based agents in traversing numerous biological barriers and how agent/patient factors affect tumor delivery, toxicities, efficacy, and ultimately, biodistribution. -
ADC Therapeutics SA (Exact Name of Registrant As Specified in Its Charter)
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of July, 2020. Commission File Number: 001-39071 ADC Therapeutics SA (Exact name of registrant as specified in its charter) Biopôle Route de la Corniche 3B 1066 Epalinges Switzerland (Address of principal executive office) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F: Form 20-F ☒ Form 40-F Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐ Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐ SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. ADC Therapeutics SA Date: July 6, 2020 By: /s/ Dominique Graz Name: Dominique Graz Title: General Counsel EXHIBIT INDEX Exhibit No. Description 99.1 Press release dated July 6, 2020 Exhibit 99.1 ADC Therapeutics Announces U.S. Food and Drug Administration Has Lifted Partial Clinical Hold on Pivotal Phase 2 Clinical Trial of Camidanlumab Tesirine Lausanne, Switzerland — July 6, 2020 — ADC Therapeutics SA (NYSE:ADCT), a clinical-stage oncology-focused biotechnology company leading the development and commercialization of next-generation antibody drug conjugates (ADCs) with highly potent and targeted pyrrolobenzodiazepine (PBD) dimer technology, today announced that the U.S. -
Comparative Effectiveness of Pembrolizumab Vs. Nivolumab In
www.nature.com/scientificreports OPEN Comparative efectiveness of pembrolizumab vs. nivolumab in patients with recurrent or advanced NSCLC Pengfei Cui1,2,4, Ruixin Li2,4, Ziwei Huang3,2,4, Zhaozhen Wu3,2, Haitao Tao2, Sujie Zhang2 & Yi Hu1,2,3* The efcacies of pembrolizumab and nivolumab have never been directly compared in a real-world study. Therefore, we sought to retrospectively evaluate the objective response rate (ORR) and the progression-free survival (PFS) of patients with recurrent or advanced non-small cell lung cancer (NSCLC) in a real-world setting. This study included patients with recurrent or advanced NSCLC diagnosed between September 1, 2015 and August 31, 2019, who were treated with programmed cell death 1 (PD-1) inhibitors at the Cancer Center of the Chinese People’s Liberation Army. PFS was estimated for each treatment group using Kaplan–Meier curves and log-rank tests. The multivariate analysis of PFS was performed with Cox proportional hazards regression models. A total of 255 patients with advanced or recurrent NSCLC treated with PD-1 inhibitors were identifed. The ORR was signifcantly higher in the pembrolizumab group than in the nivolumab group, while PFS was not signifcantly diferent between the two groups. Subgroup analysis showed that the ORR was signifcantly higher for pembrolizumab than for nivolumab in patients in the frst-line therapy subgroup and in those in the combination therapy as frst-line therapy subgroup. Survival analysis of patients receiving combination therapy as second- or further-line therapy showed that nivolumab had better efcacy than pembrolizumab. However, the multivariate analysis revealed no signifcant diference in PFS between patients treated with pembrolizumab and those treated with nivolumab regardless of the subgroup. -
Cutaneous Adverse Effects of Biologic Medications
REVIEW CME MOC Selena R. Pasadyn, BA Daniel Knabel, MD Anthony P. Fernandez, MD, PhD Christine B. Warren, MD, MS Cleveland Clinic Lerner College Department of Pathology Co-Medical Director of Continuing Medical Education; Department of Dermatology, Cleveland Clinic; of Medicine of Case Western and Department of Dermatology, W.D. Steck Chair of Clinical Dermatology; Director of Clinical Assistant Professor, Cleveland Clinic Reserve University, Cleveland, OH Cleveland Clinic Medical and Inpatient Dermatology; Departments of Lerner College of Medicine of Case Western Dermatology and Pathology, Cleveland Clinic; Assistant Reserve University, Cleveland, OH Clinical Professor, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, OH Cutaneous adverse effects of biologic medications ABSTRACT iologic therapy encompasses an expo- B nentially expanding arena of medicine. Biologic therapies have become widely used but often As the name implies, biologic therapies are de- cause cutaneous adverse effects. The authors discuss the rived from living organisms and consist largely cutaneous adverse effects of tumor necrosis factor (TNF) of proteins, sugars, and nucleic acids. A clas- alpha inhibitors, epidermal growth factor receptor (EGFR) sic example of an early biologic medication is inhibitors, small-molecule tyrosine kinase inhibitors insulin. These therapies have revolutionized (TKIs), and cell surface-targeted monoclonal antibodies, medicine and offer targeted therapy for an including how to manage these reactions -
Avelumab (Bavencio®) Prior Authorization Drug Coverage Policy
1 Avelumab (Bavencio®) Prior Authorization Drug Coverage Policy Effective Date: 9/1/2020 Revision Date: n/a Review Date: 3/6/2020 Lines of Business: Commercial Policy type: Prior Authorization This Drug Coverage Policy provides parameters for the coverage of avelumab (Bavencio®). Consideration of medically necessary indications are based upon U.S. Food and Drug Administration (FDA) indications, recommended uses within the Centers of Medicare & Medicaid Services (CMS) five recognized compendia, including the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium (Category 1 or 2A recommendations), and peer-reviewed scientific literature eligible for coverage according to the CMS, Medicare Benefit Policy Manual, Chapter 15, section 50.4.5 titled, “Off-Label Use of Anti-Cancer Drugs and Biologics.” This policy evaluates whether the drug therapy is proven to be effective based on published evidence-based medicine. Drug Description 1-2 Avelumab is a fully human IgG1 monoclonal antibody that specifically binds to PD-L1. This binding blocks the interaction between PD-L1 and its receptors, PD-1 and B7.1. Blocking PD-1 and B7.1 interaction restores anti-tumor T-cell function. FDA Indications 1 Avelumab is FDA indicated for the following: Treatment of metastatic Merkel Cell carcinoma (MCC) in adults and children ≥ 12 years of age. Treatment of locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. First-line treatment of advanced renal cell carcinoma (RCC) in combination with axitinib Coverage Determinations 1,3 Avelumab will require prior authorization. -
Bavencio; INN-Avelumab
10 December 2020 EMA/CHMP/3166/2021 Committee for Medicinal Products for Human Use (CHMP) Assessment report Bavencio International non-proprietary name: avelumab Procedure No. EMEA/H/C/004338/II/0018 Note Variation assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us An agency of the European Union Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 7 1.1. Type II variation ................................................................................................ 7 1.2. Steps taken for the assessment of the product ....................................................... 8 2. Scientific discussion ................................................................................ 9 2.1. Introduction ...................................................................................................... 9 2.1.1. Problem statement .......................................................................................... 9 2.1.2. About the product ........................................................................................... 9 2.1.3. The development programme/compliance with CHMP guidance/scientific -
Actemra® (Tocilizumab)
Actemra® (tocilizumab) (Intravenous) Document Number: MODA-0002 Last Review Date: 10/26/2020 Date of Origin: 09/21/2010 Dates Reviewed: 12/2010, 03/2011, 05/2011, 06/2011, 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 09/2012, 11/2012, 12/2012, 03/2013, 06/2013, 09/2013, 11/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 09/2015, 12/0215, 03/2016, 06/2016, 09/2016, 12/2016, 03/2017, 05/2017, 09/2017, 12/2017, 03/2018, 06/2018, 10/2018, 10/2019, 10/2020, 11/2020 I. Length of Authorization Coverage will be provided as follows: o Castleman’s Disease: 4 months and may be renewed o Cytokine Release Syndrome: 4 doses only and may not be renewed o Immune Checkpoint Inhibitor related arthritis: 1 dose and may not be renewed o All other indications: 6 months and may be renewed. II. Dosing Limits A. Quantity Limit (max daily dose) [NDC Unit]: o Actemra 80 mg/4 mL vial: 1 vial per 14 days o Actemra 200 mg/10 mL vial: 1 vial per 14 days o Actemra 400 mg/20 mL vial: 2 vials per 14 days B. Max Units (per dose and over time) [HCPCS Unit]: Diagnosis Billable Units Interval (days) Rheumatoid Arthritis & Polyarticular Juvenile Idiopathic 800 28 Arthritis, NMOSD Systemic Juvenile Idiopathic Arthritis, Castleman’s Disease (NHL) & Acute Graft Versus Host Disease 800 14 (aGVHD) Cytokine Release Syndrome (CRS) 3200 1 course of therapy only Immune Checkpoint Inhibitor related arthritis 800 1 course of therapy only III. -
Actemra (Tocilizumab) NON-ONCOLOGY POLICY (Intravenous) Department: PHA
Policy Title: Actemra (tocilizumab) NON-ONCOLOGY POLICY (Intravenous) Department: PHA Effective Date: 01/01/2020 Review Date: 09/25/2019, 12/18/2019, 1/22/2020, 8/3/2020 Revision Date: 09/25/2019, 12/18/2019, 1/22/2020, 8/3/2020 Purpose: To support safe, effective and appropriate use of Actemra (tocilizumab). Scope: Medicaid, Commerical, Medicare-Medicaid Plan (MMP) Policy Statement: Actemra (tocilizumab) is covered under the Medical Benefit when used within the following guidelines for non-oncology indications. Use outside of these guidelines may result in non-payment unless approved under an exception process. For oncology indications, please refer to NHPRI Oncology Policy Procedure: Coverage of Actemra (tocilizumab) will be reviewed prospectively via the prior authorization process based on criteria below. Initial Criteria: Patient has been evaluated and screened for the presence of latent TB infection prior to initiating treatment; AND Patient does not have an active infection, including clinically important localized infections; AND Must not be administered concurrently with live vaccines; AND Patient is not on concurrent treatment with another TNF-inhibitor, biologic response modifier or other non-biologic agent (i.e., apremilast, tofacitinib, baricitinib); MMP members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirements Rheumatoid Arthritis Patient is 18 years or older; AND Physician has assessed baseline disease severity utilizing an objective measure/tool; AND -
On the Horizon: Immuno-Oncology (I-O) Combinations
Immuno-Oncology (I-O) Combinations • Jeffrey A. Sosman, MD • Robert H. Lurie Comprehensive Cancer Center of Northwestern University The Cancer–Immunity Cycle Daniel Chen and Ira Mellman Immunity, Volume 39, Issue 1, 2013, 1 - 10 The Cancer–Immunity Cycle Daniel Chen and Ira Mellman Immunity, Volume 39, Issue 1, 2013, 1 - 10 Stimulatory and Inhibitory Factors in the Cancer-Immunity Cycle Each step of the Cancer-Immunity Cycle requires the coordination of numerous factors, both stimulatory and inhibitory in nature. Stimulatory factors shown in green promote immunity, ... Where will Improvements come from? • Combinations: – Based on Template: anti-PD-1/PD-L1 or with anti-PD- 1/anti-CTLA-4 • Block other co-inhibitory: LAG3, TIM3, KIR, VISTA • Activate co-stimulatory: 4-1BB, OX-40, GITR, CD27, ICOS • Block inhibitory molecules- IDOi, TGFbi, CSF1Ri, anti-IL-6 or anti- IL-10 • Effect trafficking- anti-VEGF, CCL5, CXCR4i • Vaccines- TVEC- oncolytic virus, Neoantigen, other cellular • Adoptive Cellular therapy- TIL, CAR-T cells, TCR T-cells Where will Improvements come from? • Combinations: – Based on Template: anti-PD-1/PD-L1 or with anti-PD- 1/anti-CTLA-4 • Signal Inhibition, BRAF directed (BRAFi+MEKi), MEKi, PI3K inhibition (PTEN effects) • Cytokines- IL-2, IFN a,b,g,, Directed cytokines (FAP-IL-2v or CEA-IL-2v) • Epigenetic modulation- gene expression and EVR expression • Microbiome modification- fecal transplants • Chemotherapy other cytotoxics • Localized Irradiation SBRT, SRS T cells in Tumors Express Multiple Immunoinhibitory Receptors -
2021 Prior Authorization List Part B Appendix a (PDF)
Medicare Part B PA List Effective 2021 Last Effective Part B Drugs: Drug Code Drug Name Action Updated Date (if Drug Description Comments STEP THERAPY Date available) C9050 INJECTION, EMAPALUMAB-LZSG, 1 MG C9122 MOMETASONE FUROATE SINUS IMPLANT 10 MCG SINUVA J0129 ABATACEPT INJECTION J0178 AFLIBERCEPT INJECTION J0570 BUPRENORPHINE IMPLANT 74.2MG J0585 INJECTION,ONABOTULINUMTOXINA J0717 CERTOLIZUMAB PEGOL INJ 1MG J0718 CERTOLIZUMAB PEGOL INJ J0791 INJECTION CRIZANLIZUMAB-TMCA 5 MG J0800 INJECTION, CORTICOTROPIN, UP TO 40 UNITS J0896 INJECTION LUSPATERCEPT-AAMT 0.25 MG J0897 DENOSUMAB INJECTION J1300 ECULIZUMAB INJECTION J1428 INJECTION ETEPLIRSEN 10 MG J1429 INJECTION GOLODIRSEN 10 MG J1442 INJ FILGRASTIM EXCL BIOSIMIL J1447 INJECTION, TBO-FILGRASTIM, 1 MICROGRAM J1459 INJ IVIG PRIVIGEN 500 MG J1555 INJECTION IMMUNE GLOBULIN 100 MG J1556 INJ, IMM GLOB BIVIGAM, 500MG J1557 GAMMAPLEX INJECTION J1558 INJECTION IMMUNE GLOBULIN XEMBIFY 100 MG J1559 HIZENTRA INJECTION J1561 GAMUNEX-C/GAMMAKED J1562 INJECTION; IMMUNE GLOBULIN 10%, 5 GRAMS J1566 INJECTION, IMMUNE GLOBULIN, INTRAVENOUS, LYOPHILIZED (E.G. P J1568 OCTAGAM INJECTION J1569 GAMMAGARD LIQUID INJECTION J1572 FLEBOGAMMA INJECTION J1575 INJ IG/HYALURONIDASE 100 MG IG J1599 IVIG NON-LYOPHILIZED, NOS J1602 GOLIMUMAB FOR IV USE 1MG J1745 INJ INFLIXIMAB EXCL BIOSIMILR 10 MG J1930 Remove 1/1/2021 INJECTION, LANREOTIDE, 1 MG J2323 NATALIZUMAB INJECTION J2350 INJECTION OCRELIZUMAB 1 MG J2353 Remove 1/1/2021 INJECTION, OCTREOTIDE, DEPOT FORM FOR INTRAMUSCULAR INJECTION, 1 MG J2357 INJECTION, OMALIZUMAB,