Takeda ja Seattle Genetics julkaisivat positiivisia tuloksia kliinisestä faasin 3 ECHELON-1-tutkimuksesta, jossa arvioidaan ADCETRIS®-valmistetta (brentuksimabivedotiini) levinneen Hodgkinin lymfooman ensilinjan hoidossa
Takeda ja Seattle Genetics raportoivat, että ECHELON-1kliinisen faasin 3 tutkimuksen tuloksia esitettiin ASH (American Society of Hematology) kongressin tärkeimmässä sessiossa sunnuntaina 10.12.2017. ECHELON-1 tutkimuksessa arvioidaan ADCETRIS-valmistetta (brentuksimabivedotiini) osana levinneen klassisen Hodgkinin lymfooman ensilinjan yhdistelmäsytostaattihoitoa. Tiedot julkaistiin samanaikaisesti New England Journal of Medicinen verkkosivulla ja tullaan julkaisemaan lehden painetussa numerossa 25.1.2018. Ensimmäiset tutkimustulosuutiset julkaistiin kesäkuussa 2017, ja niiden mukaan ECHELON-1-tutkimuksen ensisijainen päätetapahtuma – modifioidun etenemisvapaan elossaoloajan (modified progression free survival, mPFS) piteneminen – saavutettiin. ADCETRIS on vasta-aineen ja lääkeaineen konjugaatti, jonka vaikutus kohdistuu CD30-antigeeniin (klassisen Hodgkinin lymfooman markkeri). ADCETRIS ei ole tällä hetkellä hyväksytty käyttöön Hodgkinin lymfooman ensilinjan hoidossa.
“Noin kolmannes levinnyttä Hodgkinin lymfoomaa sairastavista potilaista ei saavuta pitkäkestoista remissiota vakiintuneella ensilinjan hoidolla, joten ECHELON-1-tutkimuksen tulokset saattavat olla tärkeitä tälle potilasryhmälle,” kertoi Jesús Gomez Navarro, M.D., Vice President, Head of Oncology Clinical Research and Development, Takedalta. “Tutkimuksen mukaan yhdistelmähoito ADCETRIS-valmisteen kanssa paransi mPFS-muuttujaa tilastollisesti merkitsevästi verrokkihoitoryhmään verrattuna. ADCETRIS+AVD-hoitoa saaneilla potilailla tapahtuman esiintyminen väheni 23 %:lla verrattuna ABVD-hoitoa saaneisiin potilaisiin.Modifioidun etenemisvapaan elossaoloajan tapahtumalla tarkoitetaan taudin etenemistä, kuolemaa tai jonkin muun syöpähoidon käyttöä potilailla, joiden hoitovaste ei ole täydellinen. Olemme innoissamme näistä kliinisistä tutkimustuloksista ja siitä, minkälainen vaikutus ADCETRIS-valmisteella voi olla levinnyttä Hodgkinin lymfoomaa sairastavien potilaiden hoitoon, mikäli viranomaiset hyväksyvät valmisteen käyttöön ensilinjan hoidossa.”
“Hodgkinin lymfooman vakiintunut hoito ei ole muuttunut useampaan vuosikymmeneen, ja ensilinjan hoitoon kaivataan lisää hoitovaihtoehtoja. Nykyhoidossa on mukana bleomysiini, jonka käyttöön tiedetään liittyvän vaikeasti ennustettavaa ja mahdollisesti kuolemaan johtavaa keuhkotoksisuutta,” sanoi Joseph M. Connors, M.D., FRCPC, Clinical Director, Center for Lymphoid Cancer at BC Cancer, Kanadan Vancouverista. “Kun kestävää vasteprosenttia pystytään suurentamaan ensilinjan hoidolla, joka lisäksi mahdollistaa bleomysiinin poistamisen hoidosta, Hodgkinin lymfooman hoito ottaa merkittävän askeleen eteenpäin. Taudin uusiutumisen riskin pienentäminen on tärkeä asia potilaille ja heidän lääkäreilleen. Kun tutkimuksessa verrattiin ADCETRIS-valmistetta sisältänyttä hoitoa saaneita potilaita ja ABVD-hoitoa saaneita potilaita, ADCETRIS-ryhmästä 33 % vähemmän tarvitsi jatkohoitoa sytostaateilla tai suuriannoksista sytostaattihoitoa ja kantasolusiirtoa. Lisäksi ADCETRIS+AVD-hoidon turvallisuusprofiili tutkimuksessa oli yleisesti ottaen vastaava kuin yhdistelmähoidon yksittäisillä osilla.”
“ASH valitsi kliinisen faasin 3 ECHELON-1-tutkimuksen tulokset yhdeksi vain kuudesta abstraktista, jotka esitellään tärkeimmässä kongressisessiossa, ja tiedot julkaistiin samanaikaisesti New England Journal of Medicinessä. Tämä tutkimus on rohkea hanke, joka käynnistyi yli viisi vuotta sitten tarkoituksenaan parantaa nykyistä vakiintunutta hoitokäytäntöä, joka ei ole muuttunut merkittävästi yli neljään vuosikymmeneen. Haluamme kiittää kaikkia potilaita ja lääkäreitä, jotka ovat osallistuneet tähän merkittävään tutkimukseen,” sanoi Clay Siegall, Ph.D., President and Chief Executive Officer Seattle Geneticsiltä. “Nämä tiedot osoittavat, että ADCETRIS-valmistetta sisältävä hoito on tilastollisesti selkeästi parempi vaihtoehto kuin nykyinen vakiintunut hoitomuoto ABVD. Tähän sisältyy sekä ensisijainen päätetapahtuma eli muokattu etenemisvapaa elossaoloaika riippumattoman arviointielimen, IRF:n, arvioimana että toissijaiset päätetapahtumat, joissa myös havaittiin, että ADCETRIS-valmistetta sisältävä yhdistelmähoito oli verrokkia parempi. Merkittävää on, että ADCETRIS-valmistetta sisältävää hoitoa saaneet potilaat tarvitsivat harvemmin jatkohoitoja ensilinjan hoidon jälkeen.” Takeda on toimittanut ECHELON-1 tutkimustulokset Euroopan lääkeviraston (EMA) arvioitavaksi 29.11.2017.
Brentuximab Vedotin Plus Doxorubicin, Vinblastine, Dacarbazine (A+AVD) as Frontline Therapy Demonstrates Superior Modified Progression-Free Survival versus ABVD in Patients with Previously Untreated Stage III or IV Hodgkin Lymphoma (HL): The Phase 3 ECHELON-1 Study (Plenary Scientific Session on Sunday, December 10, 3:40 p.m. ET at the Georgia World Congress Center, Building C, Level 1, Hall C2 – C3)
Key findings, which will be presented by Dr. Joseph M. Connors and published in the New England Journal of Medicine, include:
• The trial achieved its primary endpoint with the combination of ADCETRIS+AVD resulting in a statistically significant improvement in modified PFS versus the control arm of ABVD as assessed by an Independent Review Facility (IRF) (HR 0.77; p-value=0.035). This corresponds to a 23 percent reduction in the risk of progression, death or need for additional anticancer therapy.
• Per IRF assessment, the two-year modified PFS rate for patients in the ADCETRIS+AVD arm was 82.1 percent compared to 77.2 percent in the control arm.
• Per investigator assessment, the two-year modified PFS rate for patients in the ADCETRIS+AVD arm was 81.0 percent compared to 74.4 percent in the control arm (HR 0.73; p-value=0.007). This corresponds to a 27 percent reduction in the risk of progression, death or need for additional anticancer therapy.
• All secondary endpoints trended in favor of the ADCETRIS+AVD arm, including interim analysis of overall survival (OS; HR 0.72; p-value=0.19). Other secondary endpoints include:
o Complete response (CR) rate at the end of randomized regimen in the ADCETRIS+AVD arm was 73 percent compared to 70 percent in the control arm (p-value=0.22).
o Objective response rate (ORR) at the end of randomized regimen in the ADCETRIS+AVD arm was 86 percent compared to 83 percent in the control arm (p-value=0.12).
o Deauville score ≤2 after completion of frontline therapy was 85 percent in the ADCETRIS+AVD arm compared to 80 percent in the control arm (p-value=0.03).
• Certain pre-specified subgroups of patients appeared to benefit more with ADCETRIS+AVD versus ABVD including: patients treated in North America; patients with involvement of >1 extranodal site; patients with International Prognostic Score (IPS) 4 – 7; males; patients with Stage IV disease; and patients aged • In the ADCETRIS+AVD arm, 33 percent fewer patients received subsequent salvage chemotherapy or high-dose chemotherapy and transplant.
• The safety profile of ADCETRIS+AVD in the ECHELON-1 trial was generally consistent with that known for the single-agent components of the regimen.
o The most common clinically relevant adverse events of any grade that occurred in at least 15 percent of patients in the ADCETRIS+AVD and ABVD arms were: neutropenia (58 and 45 percent, respectively), constipation (42 and 37 percent, respectively), vomiting (33 and 28 percent, respectively), fatigue (both 32 percent), peripheral sensory neuropathy (29 and 17 percent, respectively), diarrhea (27 and 18 percent, respectively), pyrexia (27 and 22 percent, respectively), peripheral neuropathy (26 and 13 percent, respectively), abdominal pain (21 and 10 percent, respectively) and stomatitis (21 and 16 percent, respectively). In both the ADCETRIS+AVD and ABVD arms, the most common Grade 3 or 4 events were neutropenia, febrile neutropenia and neutrophil count decrease.
o Febrile neutropenia was reduced through the use of prophylactic growth factors (G-CSF) in a subset of patients. In the ADCETRIS+AVD arm of the study, the rate of febrile neutropenia without the use of G-CSF was 21 percent and with the use of G-CSF was reduced to 11 percent. G-CSF primary prophylaxis with ADCETRIS+AVD resulted in overall comparable safety profile to ABVD, decreasing incidence of febrile neutropenia, neutropenia and serious adverse events. Primary prophylaxis with G-CSF was recommended for all patients.
o On the ADCETRIS+AVD arm, peripheral neuropathy events were observed in 67 percent of patients compared to 43 percent on the control arm. In the ADCETRIS+AVD arm, the majority of peripheral neuropathy events were Grade 1 or 2. Grade ≥3 events were reported in 11 percent of patients and Grade 4 events were reported in less than one percent of patients. In the control arm, Grade ≥3 events were reported in two percent of patients and there were no Grade 4 events. Two-thirds of the patients with peripheral neuropathy in the ADCETRIS+AVD arm reported resolution or improvement at last follow-up.
o Pulmonary toxicity was reported in two percent of patients in the ADCETRIS+AVD arm versus seven percent of patients in the ABVD arm; Grade ≥3 events were reported in less than one percent versus three percent, in the ADCETRIS and control arms respectively.
o Nine on study deaths occurred in the ADCETRIS+AVD arm, of which seven were due to neutropenia or associated complications (all occurred in patients who had not received primary prophylaxis with G-CSF with the exception of one patient who entered the trial with pre-existing neutropenia). The remaining two deaths were due to myocardial infarction. In the control arm, there were 13 on study deaths, of which 11 were due to or associated with pulmonary-related toxicity, one was due to cardiopulmonary failure and one death had unknown cause.
ECHELON-1 Trial Design
• ECHELON-1 is a randomized, open-label, two-arm, multi-center Phase 3 study designed to compare ADCETRIS and AVD (Adriamycin, vinblastine and dacarbazine) to ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) as frontline therapy in patients with previously untreated advanced classical Hodgkin lymphoma.
• The primary endpoint is modified PFS per IRF. Modified PFS is defined as time to progression, death, or evidence of non-complete response after completion of frontline therapy per IRF followed by subsequent anticancer therapy.
• The key secondary endpoint is OS. Other secondary objectives include assessment of CR rate, ORR, event-free survival (EFS), disease-free survival (DFS), duration of response (DOR), rate of Cycle 2 PET negativity, quality of life measures (EORTC QLQ C-30) and safety profile in the ADCETRIS+AVD versus ABVD arms.
• The study enrolled 1,334 patients who had histologically-confirmed diagnosis of Stage III or IV Hodgkin lymphoma and had not been previously treated with systemic chemotherapy or radiotherapy. The median age of the patients enrolled in the study was 35 in the ADCETRIS+AVD arm and 37 in the ABVD arm.
• Patients received ADCETRIS+AVD or ABVD on Days 1 and 15 of each 28-day cycle for up to six cycles.
• The multi-center trial was conducted at 218 sites in 21 countries across North America, Europe, South America, Australia, Asia and Africa.
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for ADCETRIS in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. Seattle Genetics submitted a supplemental Biologics License Application to the FDA on November 1, 2017. Takeda has begun to submit data from the ECHELON-1 trial to regulatory agencies in its territories, starting with the European Medicines Agency (EMA) on November 29, 2017.
About Classical Hodgkin Lymphoma
Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.
According to the American Cancer Society, approximately 8,260 cases of Hodgkin lymphoma will be diagnosed in the United States during 2017 and more than 1,000 will die from the disease. According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with Hodgkin lymphoma each year and approximately 25,000 people die each year from this cancer.
ADCETRIS is being evaluated broadly in more than 70 clinical trials, including three Phase 3 studies: the ECHELON-1 trial in frontline classical Hodgkin lymphoma that supported the recent FDA Breakthrough Therapy Designation and submission of the supplemental Biologics License Application (BLA) for use in this setting, the ongoing ECHELON-2 trial in frontline mature T-cell lymphomas, and the ongoing CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma.
ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-positive tumor cells.
ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. The European Commission extended the current conditional marketing authorization of ADCETRIS and approved ADCETRIS for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT.
ADCETRIS has received marketing authorization by regulatory authorities in 69 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See important safety information below.
Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.
ADCETRIS (brentuximab vedotin) Important Safety Information (European Union)
ADCETRIS is contraindicated for patients with hypersensitivity to brentuximab vedotin and its excipients. In addition, combined use of ADCETRIS with bleomycin is contraindicated as it causes pulmonary toxicity.
SPECIAL WARNINGS & PRECAUTIONS
Progressive multifocal leukoencephalopathy (PML): John Cunningham virus (JCV) reactivation resulting in PML and death can occur in patients treated with ADCETRIS. PML has been reported in patients who received ADCETRIS after receiving multiple prior chemotherapy regimens.
Patients should be closely monitored for new or worsening neurological, cognitive, or behavioral signs or symptoms, which may be suggestive of PML. Suggested evaluation of PML includes neurology consultation, gadolinium-enhanced magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JCV DNA by polymerase chain reaction or a brain biopsy with evidence of JCV. ADCETRIS dosing should be held for any suspected case of PML and should be permanently discontinued if a diagnosis of PML is confirmed.
Pancreatitis: Acute pancreatitis has been observed in patients treated with ADCETRIS. Fatal outcomes have been reported. Patients should be closely monitored for new or worsening abdominal pain, which may be suggestive of acute pancreatitis. Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures. ADCETRIS should be held for any suspected case of acute pancreatitis. ADCETRIS should be discontinued if a diagnosis of acute pancreatitis is confirmed.
Pulmonary Toxicity: Cases of pulmonary toxicity, some with fatal outcomes, have been reported in patients receiving ADCETRIS. Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out. New or worsening pulmonary symptoms should be promptly evaluated and treated appropriately.
Serious infections and opportunistic infections: Serious infections such as pneumonia, staphylococcal bacteremia, sepsis/septic shock (including fatal outcomes), and herpes zoster, and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with ADCETRIS. Patients should be carefully monitored during treatment for emergence of possible serious and opportunistic infections.
Infusion-related reactions (IRR): Immediate and delayed IRR, as well as anaphylaxis, have occurred with ADCETRIS. Patients should be carefully monitored during and after an infusion. If anaphylaxis occurs, administration of ADCETRIS should be immediately and permanently discontinued and appropriate medical therapy should be administered. If an IRR occurs, the infusion should be interrupted and appropriate medical management instituted. The infusion may be restarted at a slower rate after symptom resolution. Patients who have experienced a prior IRR should be premedicated for subsequent infusions. IRRs are more frequent and more severe in patients with antibodies to ADCETRIS.
Tumor lysis syndrome (TLS): TLS has been reported with ADCETRIS. Patients with rapidly proliferating tumor and high tumor burden are at risk of TLS. These patients should be monitored closely and managed according to best medical practice.
Peripheral neuropathy (PN): ADCETRIS treatment may cause PN, both sensory and motor. ADCETRIS-induced PN is typically cumulative and reversible in most cases. Patients should be monitored for symptoms of PN, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Patients experiencing new or worsening PN may require a delay and a dose reduction or discontinuation of ADCETRIS.
Hematological toxicities: Grade 3 or Grade 4 anemia, thrombocytopenia, and prolonged (equal to or greater than one week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS. Complete blood counts should be monitored prior to administration of each dose.
Febrile neutropenia: Febrile neutropenia has been reported. Patients should be monitored closely for fever and managed according to best medical practice if febrile neutropenia develops.
Stevens-Johnson syndrome (SJS): SJS and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. Fatal outcomes have been reported. If SJS or TEN occurs, treatment with ADCETRIS should be discontinued and appropriate medical therapy should be administered.
Gastrointestinal (GI) Complications: GI complications, some with fatal outcomes, including intestinal obstruction, ileus, enterocolitis, neutropenic colitis, erosion, ulcer, perforation and haemorragh, have been reported. New or worsening GI symptoms should be promptly evaluated and treated appropriately.
Hepatotoxicity: Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have been reported. Serious cases of hepatotoxicity, including fatal outcomes, have also occurred. Liver function should be tested prior to treatment initiation and routinely monitored in patients receiving ADCETRIS. Patients experiencing hepatotoxicity may require a delay, dose modification, or discontinuation of ADCETRIS.
Hyperglycemia: Hyperglycemia has been reported during trials in patients with an elevated body mass index (BMI) with or without a history of diabetes mellitus. However, any patient who experiences an event of hyperglycemia should have their serum glucose closely monitored. Anti-diabetic treatment should be administered as appropriate.
Renal and Hepatic Impairment: There is limited experience in patients with renal and hepatic impairment. Available data indicate that MMAE clearance might be affected by severe renal impairment, hepatic impairment, and by low serum albumin concentrations. The recommended starting dose in patients with hepatic impairment or severe renal impairment is 1.2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. Patients with renal or hepatic impairment should be closely monitored for adverse events.
Sodium content in excipients: This medicinal product contains a maximum of 2.1 mmol (or 47 mg) of sodium per dose. To be taken into consideration for patients on a controlled sodium diet.
Patients who are receiving a strong CYP3A4 and P-gp inhibitor, concomitantly with ADCETRIS may have an increased risk of neutropenia and should be closely monitored. Co-administration of ADCETRIS with a CYP3A4 inducer did not alter the plasma exposure of ADCETRIS but it appeared to reduce plasma concentrations of MMAE metabolites that could be assayed. ADCETRIS is not expected to alter the exposure to drugs that are metabolized by CYP3A4 enzymes.
PREGNANCY: Women of childbearing potential should be using two methods of effective contraception during treatment with ADCETRIS and until 6 months after treatment. There are no data from the use of ADCETRIS in pregnant women, although studies in animals have shown reproductive toxicity. ADCETRIS should not be used during pregnancy unless the benefit to the mother outweighs the potential risks to the fetus. If a pregnant woman needs to be treated, she should be clearly advised on the potential risk to the fetus.
LACTATION (breast-feeding): There are no data as to whether ADCETRIS or its metabolites are excreted in human milk, therefore a risk to the newborn/infant cannot be excluded. With the potential risk, a decision should be made whether to discontinue breast-feeding or discontinue/abstain from therapy with ADCETRIS.
FERTILITY: In nonclinical studies, ADCETRIS treatment has resulted in testicular toxicity, and may alter male fertility. Men being treated with this medicine are advised not to father a child during treatment and for up to 6 months following the last dose.
Serious adverse drug reactions were: pneumonia, acute respiratory distress syndrome, headache, neutropenia, thrombocytopenia, constipation, diarrhea, vomiting, nausea, pyrexia, peripheral motor neuropathy, peripheral sensory neuropathy, hyperglycemia, demyelinating polyneuropathy, tumor lysis syndrome, and Stevens-Johnson syndrome.
In the clinical studies of ADCETRIS, adverse reactions defined as very common (≥1/10) were: infection, upper respiratory tract infection, neutropenia, PN (sensory and motor), cough, dyspneoa, diarrhea, nausea, vomiting, constipation, abdominal pain, alopecia, pruritus, myalgia, arthralgia, fatigue, chills, pyrexia, infusion-related reactions and weight decreased. Adverse reactions defined as common (≥1/100 to <1/10) were: Sepsis/septic shock, herpes zoster, pneumonia, herpes simplex, anemia, thrombocytopenia, hyperglycemia, dizziness, demyelinating polyneuropathy, ALT/AST increased, rash, and back pain.
Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries.
About Seattle Genetics
Seattle Genetics is an innovative biotechnology company dedicated to improving the lives of people with cancer through novel antibody-based therapies. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. Seattle Genetics commercializes ADCETRIS®(brentuximab vedotin) for the treatment of several types of CD30-expressing lymphomas. The company is also advancing a robust pipeline of novel therapies for solid tumors and blood-related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients.
Forward Looking Statements for Seattle Genetics
Certain of the statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of ADCETRIS (brentuximab vedotin) and possible benefits from its use, and anticipated regulatory approval from the FDA and other regulatory authorities for frontline Hodgkin lymphoma in the possible time frame and for the possible uses stated above. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the possibility that the safety and/or efficacy results of the ECHELON-1 trial in Hodgkin lymphoma will not be sufficient to gain marketing approval in the United States or any other country, that we will be required to amend our submission for marketing approval or that approval for such submission will be refused or delayed or conditioned or that the approved uses will be narrower in scope than stated above. In addition, our regulatory plans may change as a result of consultation with the FDA or other regulatory authorities. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption “Risk Factors” included in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Lääketieteellinen johtaja Klaus Tamminen