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Janssen to Present Robust Evidence for Solid Tumour Portfolio and Pipeline at 2021 ASCO GU

On February 3, 2021 The Janssen Pharmaceutical Companies of Johnson & Johnson reported it will highlight the depth of its solid tumour portfolio at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (ASCO GU) Cancers Symposium with 12 data presentations, including three company-sponsored oral presentations from the apalutamide clinical development program (Press release, Johnson & Johnson, FEB 3, 2021, View Source [SID1234574575]). The virtual meeting will take place 11-13 February.

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"Janssen’s extensive data presentations at ASCO (Free ASCO Whitepaper) GU are testament of our commitment to clinical research in genitourinary cancers — to deliver innovative therapies that improve patient outcomes and address critical unmet needs," said Dr Joaquín Casariego, M.D., Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A. "The latest research from the TITAN Phase 3 trial and our prostate cancer portfolio improves clinical understanding and opens new treatment pathways for a broader group of patients."

New Analyses for Apalutamide Phase 3 Studies Highlight Breadth of Ongoing Clinical Development Program

Data from three Phase 3 registrational clinical trials will be featured in oral presentations:

ACIS: Analysis evaluating apalutamide in combination with abiraterone acetate plus prednisone versus abiraterone acetate plus prednisone in patients with chemo-naïve metastatic castration-resistant prostate cancer (Abstract #9)1
TITAN: Final analysis with close to four years of follow-up data evaluating apalutamide versus placebo on overall survival (OS) and other endpoints in patients with metastatic hormone-sensitive prostate cancer (mHSPC) receiving hormone therapy (Abstract #11)2
SPARTAN: Post-hoc analysis data from a biomarker cohort study identifying the molecular signatures associated with long-term response to apalutamide (Abstract #8)3
Combined, the apalutamide focused presentations include data from more than 2,000 patients across multiple studies. Apalutamide has shown a statistically significant improvement in OS in its approved indications of metastatic hormone-sensitive prostate cancer (TITAN) and non-metastatic castration-resistant prostate cancer (SPARTAN).4 Both TITAN and SPARTAN trials confirm the safety of apalutamide, with over four years of patient follow-up demonstrating exposure-adjusted rates of Grade 3 and 4 adverse events for apalutamide that are comparable to androgen deprivation therapy alone.5

Further details about these data and the science that Janssen is advancing for patients with genitourinary cancers will be made available at ASCO (Free ASCO Whitepaper) GU via the Janssen media event, Prioritising Prostate Cancer (February 12th, 2021 at 16:30 CET).

Abstracts to be presented at the meeting include:

Abstract No.

Title

Date/Time

Apalutamide

Oral Presentations

Abstract #8

Molecular Determinants Associated with Long-Term Response to Apalutamide in Non-Metastatic Castration-Resistant Prostate Cancer

Thursday,

February 11
6:45 PM – 8:00 PM CET

Abstract #9

Results from ACIS, a Randomized, Placebo-Controlled Double-Blind Phase 3 Study of Apalutamide and Abiraterone Acetate Plus Prednisone (AAP) Versus AAP in Patients with Chemo-Naive Metastatic Castration-Resistant Prostate Cancer

Thursday,

February 11
6:45 PM – 8:00 PM CET

Abstract #11

Final Analysis Results From TITAN: A Phase 3 Study of Apalutamide vs Placebo in Patients with Metastatic Castration-Sensitive Prostate Cancer Receiving Androgen Deprivation Therapy

Thursday,

February 11
9:30 PM – 10:15 PM CET

Poster Presentations

Abstract #44

Medication Adherence Among Prostate Cancer Patients Using Advanced Oral Therapies

Poster Session: Prostate Cancer – Advanced Disease, available on-demand throughout the meeting

Abstract #64

Health-Related Quality of Life Analysis from a Randomized Phase 2 Trial of Androgen Signaling Inhibitors with or without Androgen Deprivation Therapy for Castration-Sensitive Prostate Cancer: LACOG0415

Poster Session: Prostate Cancer – Advanced Disease, available on-demand throughout the meeting

Abstract #83

Outcomes in Men with Metastatic Castrate-Resistant Prostate Cancer Treated with Early Platinum-Based Chemotherapy Following an Unsatisfactory Response to Androgen Receptor Inhibition as Part of the Phase 2 Dynamic Allocation Modular Sequential (DynAMo) Trial

Poster Session: Prostate Cancer – Advanced Disease, available on-demand throughout the meeting

Abstract #90

Interim Analysis of STARTAR: A Phase 2 Salvage Trial of Androgen Receptor Inhibition with Androgen Deprivation Therapy and Apalutamide with Radiation Therapy Followed by Docetaxel in Men with PSA Recurrent Prostate Cancer After Radical Prostatectomy

Poster Session: Prostate Cancer – Advanced Disease, available on-demand throughout the meeting

Erdafitinib

Poster Presentation

Abstract #426

Management of Fibroblast Growth Factor Receptor Inhibitor Treatment-Emergent Adverse Events of Interest in Patients with Locally Advanced or Metastatic Urothelial Carcinoma

Poster Session: Urothelial Carcinoma, available on-demand throughout the meeting

Niraparib

Poster Presentation

Abstract #TPS176

AMPLITUDE: A Study of Niraparib in Combination with Abiraterone Acetate Plus Prednisone (AAP) Versus AAP for the Treatment of Patients with Deleterious Germline or Somatic Homologous Recombination Repair Gene-Altered Metastatic Castration-Sensitive Prostate Cancer

Trials in Progress Poster Session: Advanced Prostate Cancer, available on-demand throughout the meeting

Other

Poster Presentations

Abstract #47

Real-World Utilization of Docetaxel Among Men with De Novo Metastatic Castration-Sensitive Prostate Cancer: A Population-Based Study in Men Aged 66 or Older

Poster Session: Prostate Cancer – Advanced Disease, available on-demand throughout the meeting

Abstract #50

Geographic Variation in Systemic Therapy in Men Age 66 Years and Older With De Novo Metastatic Castration Sensitive Prostate Cancer: A Population-Based Study in a Single Payer Health-System

Poster Session: Prostate Cancer – Advanced Disease, available on-demand throughout the meeting

Abstract #149

Prognostic Association Between Common Laboratory Tests and Overall Survival in Men with De Novo Metastatic Castration-Sensitive Prostate Cancer: A Population-Based Study

Poster Session: Prostate Cancer – Advanced Disease, available on-demand throughout the meeting

# #END# #

About apalutamide

Apalutamide is an orally administered, selective androgen receptor (AR) inhibitor approved in Europe and is indicated in

adult men for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease, and
in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), also known as metastatic castration-sensitive prostate cancer (mCSPC), in combination with androgen deprivation therapy (ADT). 4
About abiraterone acetate

Abiraterone acetate, an orally administered androgen biosynthesis inhibitor, in combination with prednisone or prednisolone is approved in Europe for

the treatment of newly diagnosed high risk metastatic hormone-sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT);
the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of ADT in whom chemotherapy is not yet clinically indicated, and
the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.6
Additionally, abiraterone acetate was approved for the treatment of high-risk metastatic hormone-sensitive prostate cancer (mHSPC) by the U.S. FDA on February 8, 2018.7,8 Since its first approval in Europe in 2011, abiraterone acetate has been approved in combination with prednisone or prednisolone, in more than 105 countries and has been prescribed to more than 700,000 patients worldwide.8

About erdafitinib

Erdafitinib is a once-daily, oral fibroblast growth factor receptor (FGFR) kinase inhibitor that is being studied in patients with selected FGFR gene alterations in locally advanced or metastatic urothelial cancer, in Bacillus Calmette-Guérin (BCG) experienced, high risk non-muscle-invasive bladder cancer and in advanced solid tumours.9,10,11,12,13 In 2019 erdafitinib was approved in the U.S. for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) that has susceptible FGFR3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.14 In 2008, Janssen entered into an exclusive worldwide license and collaboration agreement with Astex Pharmaceuticals to develop and commercialise erdafitinib.15

About niraparib

Niraparib is an orally administered, selective poly (ADP ribose) polymerase (PARP) inhibitor that is currently being studied by Janssen for the treatment of patients with prostate cancer. Ongoing studies include the Phase 3 AMPLITUDE study evaluating niraparib in combination with abiraterone acetate plus prednisone in a biomarker-selected patient population with mHSPC;16 the Phase 3 MAGNITUDE study evaluating niraparib in combination with abiraterone acetate plus prednisone in adults with mCRPC;17 and QUEST, a Phase 1b/2 study of niraparib combination therapies for the treatment of mCRPC.18

In April 2016, Janssen entered a worldwide (except Japan) collaboration and license agreement with TESARO, Inc. (acquired by GSK in 2018), for exclusive rights to niraparib in prostate cancer.19 In Europe, niraparib is indicated for the maintenance treatment of adult patients with advanced epithelial high-grade ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy; for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.20

FDA Approves TEPMETKO® as the First and Only Once-daily Oral MET Inhibitor for Patients with Metastatic NSCLC with METex14 Skipping Alterations

On February 3, 2021 EMD Serono, the healthcare business sector of Merck KGaA, Darmstadt, Germany in the US and Canada, reported that the US Food and Drug Administration (FDA) has approved TEPMETKO (tepotinib) following Priority Review for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations (Press release, EMD Serono, FEB 3, 2021, View Source [SID1234574574]). This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

The approval is based on results from the pivotal Phase II VISION study evaluating TEPMETKO as monotherapy in patients with advanced NSCLC with METex14 skipping alterations.

"METex14 skipping occurs in approximately 3% to 4% of NSCLC cases, and patients with this aggressive lung cancer are often elderly and face a poor clinical prognosis," said Paul K. Paik, M.D., VISION primary investigator and Clinical Director, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center. "There is a pressing need for targeted treatments that have the potential to generate durable anti-tumor activity and improve the lives of patients with this challenging disease. TEPMETKO offers an important and welcome new therapeutic option for patients with metastatic NSCLC harboring these genetic mutations."

"In recent years, the treatment of lung cancer has seen powerful progress in the understanding of the genetic mutations that lead to tumor growth, resistance and progression," said Andrea Ferris, President and CEO of LUNGevity. "The availability of a new precision medicine for NSCLC with METex14 skipping alterations advances patient access to targeted treatment and underscores the importance of routine comprehensive biomarker testing for patients with this challenging cancer."

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TEPMETKO is the first and only FDA approved MET inhibitor that offers once-daily oral dosing and is administered as two 225 mg tablets (450 mg). Patients with metastatic NSCLC should be selected for treatment with TEPMETKO based on the presence of MET exon 14 skipping alterations.

"This approval of TEPMETKO by the FDA is an important milestone on our mission to significantly improve the treatment of cancer where MET plays a driving role," said Danny Bar-Zohar, M.D., Global Head of Development for the Healthcare business of Merck KGaA, Darmstadt, Germany. "Our focus now is to ensure TEPMETKO is accessible to patients in the United States and fully integrated into clinical practice given the important advance it represents for indicated patients as an oral once-a-day precision medicine."

EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany in the US and Canada, is committed to providing patient access and reimbursement support for eligible TEPMETKO patients through its Oncology Navigation Center (ONC) program in the US. ONC provides a spectrum of patient access and reimbursement support services intended to help US patients receive appropriate treatment access. ONC may be reached at 1-844-662-3631 (844-ONC-EMD1) between 8am-8pm Eastern Time, Monday through Friday, or by visiting OncNavigationCenter.com.

TEPMETKO was the first oral MET inhibitor to receive a regulatory approval anywhere in the world for the treatment of advanced NSCLC harboring MET gene alterations, with its approval in Japan in March 2020. The FDA completed its review of TEPMETKO under its Real-Time Oncology Review pilot program after previously granting the medicine Breakthrough Therapy Designation. The FDA also recently granted TEPMETKO Orphan Drug Designation (ODD).

A Marketing Authorization Application for tepotinib for a similar indication was validated by the European Medicines Agency in November 2020. Applications have also been submitted in Australia, Switzerland, and Canada under the FDA’s Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners.1

VISION Study Pivotal Trial Results
VISION (NCT02864992) is an ongoing pivotal Phase II, multicenter, multi-cohort, single-arm, non-randomized, open-label study investigating tepotinib as monotherapy in 152 patients with a median age of 73 years with advanced or metastatic non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping alterations. Eligible patients were required to have advanced or metastatic NSCLC harboring METex14 skipping alterations, epidermal growth factor receptor (EGFR) wild-type and anaplastic lymphoma kinase (ALK) negative status, at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. Patients received TEPMETKO 450 mg once daily until disease progression or unacceptable toxicity. The major efficacy outcome measure is overall response rate (ORR) according to RECIST version 1.1 as assessed by a blinded independent review committee (BIRC). An additional efficacy outcome measure was duration of response (DOR) by BIRC. Patients with symptomatic CNS metastases, clinically significant uncontrolled cardiac disease, or who received treatment with any MET or hepatocyte growth factor (HGF) inhibitor were not eligible for the study. Data from the primary analysis of the VISION study were previously published online in The New England Journal of Medicine.2

In the study, TEPMETKO demonstrated an overall response rate of 43% (95% CI, 32–56) in treatment-naïve patients (n=69) and 43% (95% CI, 33-55) in previously treated patients (n=83). Median duration of response (DOR) was 10.8 months (95% CI, 6.9-NE) and 11.1 months (95% CI, 9.5-18.5) among treatment-naïve and previously treated patients, respectively. Duration of response of six months or more occurred among 67% of treatment-naïve patients and 75% of previously treated patients, and duration of response of nine months or more occurred among 30% of treatment-naïve patients and 50% of previously treated patients.3

The safety population included 255 patients with NSCLC positive for METex14 skipping alterations, who received TEPMETKO in the VISION study. Fatal adverse reactions occurred in one patient (0.4%) due to pneumonitis, one patient (0.4%) due to hepatic failure, and one patient (0.4%) due to dyspnea from fluid overload. Serious adverse reactions occurred in 45% of patients who received TEPMETKO. Serious adverse reactions occurring in >2% of patients included pleural effusion (7%), pneumonia (5%), edema (3.9%), dyspnea (3.9%), general health deterioration (3.5%), pulmonary embolism (2%), and musculoskeletal pain (2%). The most common adverse reactions (≥20%) in patients who received TEPMETKO were edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea.

About Non-Small Cell Lung Cancer
With 2 million cases diagnosed annually, lung cancer (including trachea, bronchus and lung) is the most common type of cancer worldwide and the leading cause of cancer-related death, with 1.9 million mortality cases worldwide each year.4 In the US in 2020, there were an estimated 228,820 new cases of lung cancer and more than 135,000 deaths from lung cancer.5 Alterations of the MET signaling pathway, including MET exon 14 (METex14) skipping alterations, are estimated to occur in 3% to 4% of NSCLC cases.6

About TEPMETKO (tepotinib)
TEPMETKO is an oral MET inhibitor that inhibits the oncogenic MET receptor signaling caused by MET (gene) alterations. Discovered and developed in-house at Merck KGaA, Darmstadt, Germany, TEPMETKO has a highly selective mechanism of action, with the potential to improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations.7

Additional Clinical Investigations: Tepotinib is also being investigated in the Phase II INSIGHT 2 study in combination with osimertinib in MET amplified, advanced or metastatic NSCLC harboring activating EGFR mutations that has progressed following first-line treatment with osimertinib, and in the Phase II PERSPECTIVE study in combination with cetuximab in patients with RAS/BRAF wild-type left-sided metastatic colorectal cancer having acquired resistance to anti-EGFR antibody targeting therapy due to MET amplification.

Important Safety Information
TEPMETKO can cause interstitial lung disease (ILD)/pneumonitis, which can be fatal. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Immediately withhold TEPMETKO in patients with suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis are identified. ILD/pneumonitis occurred in 2.2% of patients treated with TEPMETKO, with one patient experiencing a Grade 3 or higher event; this event resulted in death.

TEPMETKO can cause hepatotoxicity, which can be fatal. Monitor liver function tests (including ALT, AST, and total bilirubin) prior to the start of TEPMETKO, every 2 weeks during the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop increased transaminases or total bilirubin. Based on the severity of the adverse reaction, withhold, dose reduce, or permanently discontinue TEPMETKO. Increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST) occurred in 13% of patients treated with TEPMETKO. Grade 3 or 4 increased ALT/AST occurred in 4.2% of patients. A fatal adverse reaction of hepatic failure occurred in one patient (0.2%). The median time-to-onset of Grade 3 or higher increased ALT/AST was 30 days (range 1 to 178).

TEPMETKO can cause embryo-fetal toxicity. Based on findings in animal studies and its mechanism of action, TEPMETKO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential or males with female partners of reproductive potential to use effective contraception during treatment with TEPMETKO and for one week after the final dose.

Avoid concomitant use of TEPMETKO with dual strong CYP3A inhibitors and P-gp inhibitors and strong CYP3A inducers. Avoid concomitant use of TEPMETKO with certain P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.

Fatal adverse reactions occurred in one patient (0.4%) due to pneumonitis, one patient (0.4%) due to hepatic failure, and one patient (0.4%) due to dyspnea from fluid overload.

Serious adverse reactions occurred in 45% of patients who received TEPMETKO. Serious adverse reactions in >2% of patients included pleural effusion (7%), pneumonia (5%), edema (3.9%), dyspnea (3.9%), general health deterioration (3.5%), pulmonary embolism (2%), and musculoskeletal pain (2%).

The most common adverse reactions (≥20%) in patients who received TEPMETKO were edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea.

Clinically relevant adverse reactions in <10% of patients who received TEPMETKO included ILD/pneumonitis, rash, fever, dizziness, pruritus, and headache.

Selected laboratory abnormalities (≥20%) from baseline in patients receiving TEPMETKO in descending order were: decreased albumin (76%), increased creatinine (55%), increased alkaline phosphatase (ALP) (50%), decreased lymphocytes (48%), increased alanine aminotransferase (ALT) (44%), increased aspartate aminotransferase (AST) (35%), decreased sodium (31%), decreased hemoglobin (27%), increased potassium (25%), increased gamma-glutamyltransferase (GGT) (24%), increased amylase (23%), and decreased leukocytes (23%).

The most common Grade 3 to 4 laboratory abnormalities (≥2%) in descending order were: decreased lymphocytes (11%), decreased albumin (9%), decreased sodium (8%), increased GGT (5%), increased amylase (4.6%), increased ALT (4.1%), increased AST (2.5%), and decreased hemoglobin (2%).

A clinically relevant laboratory abnormality in <20% of patients who received TEPMETKO was increased lipase in 18% of patients, including 3.7% Grades 3 to 4.

For more information about TEPMETKO, please see full Prescribing Information, and visit www.TEPMETKO.com.

References

US Food and Drug Administration. Project Orbis. View Source Accessed February 2021.
Paik PK, Felip E, Veillon R, et al. Tepotinib in non–small-cell lung cancer with MET exon 14 skipping mutations. N Engl J Med 2020; 383:931-943.
TEPMETKO Prescribing Information. Rockland, MA: EMD Serono Inc.; 2021.
Global Burden of Disease Cancer Collaboration. Global, regional, and national cancer cadence, mortality, years of life lost, years lived with disability, and disability-adjusted life-years for 29 cancer groups, 1990 to 2017; a systematic analysis for the Global Burden of Disease Study. JAMA Oncol. 2019;5:1749–1768.
American Cancer Society. Key Statistics for Lung Cancer. American Cancer Society. Atlanta, Ga. 2020. Accessed at View Source Accessed February 2021.
Reungwetwattana T, Liang Y, Zhu V, Ou SHI. The race to target MET exon 14 skipping alterations in non-small cell lung cancer: The Why, the How, the Who, the Unknown, and the Inevitable. Lung Cancer. 2017;103:27–37.
Bladt F, Faden B, Friese-Hamim M, et al. EMD 1214063 and EMD 1204831 constitute a new class of potent and highly selective c-Met inhibitors. Clin Cancer Res. 2013;19:2941-2951.
Disclosure: Dr. Paik has provided consulting/advisory services for EMD Serono.

All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go to www.emdgroup.com/subscribe to register again for your online subscription of this service as our newly introduced geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

OPKO Health to Report Fourth Quarter 2020 Financial Results on February 18, 2021

On February 3, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported that operating and financial results for the three months ended December 31, 2020, as well as discuss financial guidance, after the close of the U.S. financial markets on Thursday, February 18, 2021 (Press release, Opko Health, FEB 3, 2021, View Source [SID1234574573]). OPKO’s senior management will provide a business update and discuss results in greater detail during a conference call and live audio webcast on February 18th beginning at 4:30 p.m. Eastern time.

CONFERENCE CALL & WEBCAST INFORMATION

OPKO encourages participants to pre-register for the conference call using the link here or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 8597848. Upon registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call.

To access the live call via webcast, please click on the link OPKO 4Q20 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call’s Q&A session are encouraged to listen to the call via the webcast.

For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO’s website at OPKO 4Q20 Results Conference Call. A telephone replay will be available beginning approximately two hours after the close of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 8597848.

Horizon Therapeutics plc to Release Fourth-Quarter and Full-Year 2020 Financial Results and Host Webcast on Feb. 24, 2021

On February 3, 2021 Horizon Therapeutics plc (Nasdaq: HZNP) reported that its fourth-quarter and full-year 2020 financial results will be released on Wednesday, Feb. 24, 2021 (Press release, Horizon Therapeutics, FEB 3, 2021, View Source [SID1234574572]). Following the announcement, Horizon’s management will host a live webcast at 8 a.m. Eastern Time to review the Company’s financial and operating results.

The live webcast and a replay may be accessed at View Source Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the webcast will be available approximately two hours after the live webcast.

Affimed Announces Collaboration with Roche to Study AFM24 in Combination with PD-L1 Checkpoint Inhibitor in EGFR Expressing Solid Tumors

On February 3, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that it has entered into a clinical research collaboration with Roche to explore the combination of Affimed’s innate cell engager (ICE) AFM24 with Roche’s PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) (Press release, Affimed, FEB 3, 2021, View Source [SID1234574571]).

Under the terms of the agreement, Affimed will fund and conduct a Phase 1/2a clinical trial to investigate the combination of AFM24 and atezolizumab for the treatment of advanced solid epidermal growth factor receptor (EGFR) expressing malignancies in patients whose disease has progressed after treatment with previous anticancer therapies. Roche will supply Affimed with atezolizumab for the clinical trial. The Phase 1/2a study will establish a dosing regimen for the combination therapy and assess safety and potential activity.

"AFM24 is a first-in-class innate cell engager that we believe has the potential to bring benefit to a broad set of patients as monotherapy and in combination with other I/O therapies to address disease states where co-activation of the innate and adaptive immune systems is beneficial," said Dr. Adi Hoess, CEO of Affimed. "This collaboration with Roche is an important step in our continued execution of AFM24’s clinical development strategy. Importantly, preclinical and clinical studies indicate that ICE and PD-(L)1 checkpoint inhibition therapy could act synergistically, which drives our optimism about the combination of AFM24 with atezolizumab and its promise as a possible treatment option for patients with EGFR expressing solid tumors."

AFM24 is a novel tetravalent, bispecific EGFR- and CD16A-binding innate cell engager that activates innate immunity by inducing both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). AFM24 has shown an acceptable safety profile and antitumor activity in preclinical studies. AFM24 is currently being evaluated as monotherapy in adult patients with advanced solid malignancies known to be EGFR-positive in an open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study.