On June 12, 2017 Exelixis, Inc. (NASDAQ:EXEL) reported the initiation of the dose-escalation stage of a phase 1b trial of cabozantinib in combination with atezolizumab (TECENTRIQ) in patients with locally advanced or metastatic urothelial carcinoma (UC) or renal cell carcinoma (RCC) (Press release, Exelixis, JUN 12, 2017, View Source [SID1234519497]). The primary objective is to determine the optimal dose and schedule of daily oral administration of cabozantinib when given in combination with atezolizumab to inform the trial’s subsequent expansion stage. Schedule your 30 min Free 1stOncology Demo! "Patients with locally advanced or metastatic urothelial or renal cell carcinoma are in need of additional therapies that can slow disease progression," said Sumanta Kumar Pal, M.D., Co-director, Kidney Cancer Program at City of Hope, and Principal Investigator of the study. "As new investigational and approved therapies become available, research into their use in combination with other treatments may be a productive avenue for improving clinical outcomes in patients with these tumor types. Identifying the appropriate dose for cabozantinib when paired with the immunotherapy atezolizumab is the first step in examining this potential combination therapy."
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This multicenter phase 1b, open-label study is divided in two parts: a dose-escalation phase and an expansion cohort phase. The dose-escalation phase will enroll 9 to 36 patients with inoperable, locally advanced, metastatic or recurrent UC (including renal, pelvis, ureter, urinary bladder and urethra) after prior platinum-based therapy or RCC with or without prior systemic therapy. The starting dose of cabozantinib will be 40 mg daily and may be increased to 60 mg daily or decreased to 20 mg daily. All patients will receive the standard atezolizumab dosing regimen (1200 mg infusion once every 3 weeks).
The secondary objectives of the dose-escalation stage are to evaluate the plasma pharmacokinetics of daily oral administration of cabozantinib when given in combination with atezolizumab and to assess safety of the combination therapy through the evaluation of incidence and severity of adverse events, including immune-related adverse events. Exploratory endpoints include the correlation of clinical outcome with immune cell, tumor cell and blood biomarker analyses.
Once the recommended dose and schedule are determined, the trial will enroll four expansion cohorts, each with up to 30 patients, for a total of up to 120 patients with advanced or metastatic UC or RCC. The primary objective in the expansion stage of the trial is to determine the objective response rate in each cohort. The three UC expansion cohorts will enroll: 1) patients who have progressed on or after platinum-containing chemotherapy; 2) patients who are ineligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy for inoperable, locally advanced or metastatic disease; and 3) patients who are eligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy for inoperable, locally advanced or metastatic disease. The RCC expansion cohort will enroll patients with clear cell histology who have not had prior systemic anticancer therapy.
"There is a strong rationale for combining cabozantinib with immunotherapies, including clinical and preclinical observations consistent with the ability of cabozantinib to promote an immuno-permissive environment, which might present an opportunity for synergistic effects from combination treatment with immune checkpoint inhibitors and other immuno-oncology agents," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. "We are excited to evaluate the combination of cabozantinib plus atezolizumab and look forward to the determination of a recommended phase 2 dose and to further examining this combination regimen to treat advanced cancers."
More information about this trial is available at ClinicalTrials.gov.
TECENTRIQ (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
About Exelixis’ Collaboration with Ipsen
On February 29, 2016, Exelixis and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications outside of the United States, Canada and Japan. On December 21, 2016, this agreement was amended to include commercialization rights for Ipsen in Canada. Ipsen has opted in to participate in the funding of the phase 1b trial in patients with locally advanced or metastatic UC or RCC. They may also participate in future studies at their choosing and would have access to the results to support potential future regulatory submissions.
About Exelixis’ Collaboration with Takeda
On January 30, 2017, Exelixis and Takeda jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications in Japan. Takeda may also participate in these and future studies and have access to the results to support potential future regulatory submissions in their territories, if they opt into their funding obligations under the respective collaboration agreements. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States.
About Genitourinary Cancers
Genitourinary cancers are those that affect the urinary tract, bladder, kidneys, ureter, prostate, testicles, penis or adrenal glands — parts of the body involved in reproduction and excretion — and include renal cell carcinoma (RCC) and urothelial carcinoma (UC).1
Kidney cancer is among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S., according to the American Cancer Society’s 2017 statistics.2 Clear cell RCC is the most common type of kidney cancer in adults.3 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 12 percent, with no identified cure for the disease.2 Approximately 30,000 patients in the U.S. and 68,000 globally require treatment.4
Prostate cancer is the second most common cause of cancer death in men, behind only skin cancer.5 There is a high survival rate for patients when prostate cancer is detected early, but once the disease has spread to other parts of the body the five-year survival rate is just 28 percent.6 Approximately 3,085,000 men were living with prostate cancer in the U.S. in 2014,7 and an estimated 160,000 new cases will be diagnosed this year.5
Urothelial cancers encompass carcinomas of the bladder, ureter and renal pelvis at a ratio of 50:3:1, respectively.8 Urothelial carcinoma occurs mainly in older people, with 90 percent of patients aged 55 or older.9 Bladder cancer is the fourth most common cancer in men and accounts for about five percent of all new cases of cancer in the U.S. each year.9 In 2014, an estimated 696,440 people were living with bladder cancer in the U.S.10
About CABOMETYX (cabozantinib)
CABOMETYX is the tablet formulation of cabozantinib. Its targets include MET, AXL and VEGFR-1, -2 and -3. In preclinical models, cabozantinib has been shown to inhibit the activity of these receptors, which are involved in normal cellular function and pathologic processes such as tumor angiogenesis, invasiveness, metastasis and drug resistance.
CABOMETYX is available in 20 mg, 40 mg or 60 mg doses. The recommended dose is 60 mg orally, once daily.
On April 25, 2016, the FDA approved CABOMETYX tablets for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. On September 9, 2016, the European Commission approved CABOMETYX tablets for the treatment of advanced renal cell carcinoma in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy in the European Union, Norway and Iceland.
Cabozantinib is not indicated for the treatment of locally advanced or metastatic UC.
U.S. Important Safety Information
Hemorrhage: Severe hemorrhage occurred with CABOMETYX. The incidence of Grade ≥3 hemorrhagic events was 2.1% in CABOMETYX-treated patients and 1.6% in everolimus-treated patients. Fatal hemorrhages also occurred in the cabozantinib clinical program. Do not administer CABOMETYX to patients that have or are at risk for severe hemorrhage.
Gastrointestinal (GI) Perforations and Fistulas: Fistulas were reported in 1.2% (including 0.6% anal fistula) of CABOMETYX-treated patients and 0% of everolimus-treated patients. GI perforations were reported in 0.9% of CABOMETYX-treated patients and 0.6% of everolimus-treated patients. Fatal perforations occurred in the cabozantinib clinical program. Monitor patients for symptoms of fistulas and perforations. Discontinue CABOMETYX in patients who experience a fistula that cannot be appropriately managed or a GI perforation.
Thrombotic Events: CABOMETYX treatment results in an increased incidence of thrombotic events. Venous thromboembolism was reported in 7.3% of CABOMETYX-treated patients and 2.5% of everolimus-treated patients. Pulmonary embolism occurred in 3.9% of CABOMETYX-treated patients and 0.3% of everolimus-treated patients. Events of arterial thromboembolism were reported in 0.9% of CABOMETYX-treated patients and 0.3% of everolimus-treated patients. Fatal thrombotic events occurred in the cabozantinib clinical program. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or any other arterial thromboembolic complication.
Hypertension and Hypertensive Crisis: CABOMETYX treatment results in an increased incidence of treatment-emergent hypertension. Hypertension was reported in 37% (15% Grade ≥3) of CABOMETYX-treated patients and 7.1% (3.1% Grade ≥3) of everolimus-treated patients. Monitor blood pressure prior to initiation and regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume CABOMETYX at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy. Discontinue CABOMETYX if there is evidence of hypertensive crisis or severe hypertension despite optimal medical management.
Diarrhea: Diarrhea occurred in 74% of patients treated with CABOMETYX and in 28% of patients treated with everolimus. Grade 3 diarrhea occurred in 11% of CABOMETYX-treated patients and in 2% of everolimus-treated patients. Withhold CABOMETYX in patients who develop intolerable Grade 2 diarrhea or Grade 3-4 diarrhea that cannot be managed with standard antidiarrheal treatments until improvement to Grade 1; resume CABOMETYX at a reduced dose. Dose modification due to diarrhea occurred in 26% of patients.
Palmar-Plantar Erythrodysesthesia Syndrome (PPES): Palmar-plantar erythrodysesthesia syndrome (PPES) occurred in 42% of patients treated with CABOMETYX and in 6% of patients treated with everolimus. Grade 3 PPES occurred in 8.2% of CABOMETYX-treated patients and in <1% of everolimus-treated patients. Withhold CABOMETYX in patients who develop intolerable Grade 2 PPES or Grade 3 PPES until improvement to Grade 1; resume CABOMETYX at a reduced dose. Dose modification due to PPES occurred in 16% of patients.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in the cabozantinib clinical program. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.
Embryo-fetal Toxicity: CABOMETYX 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 to use effective contraception during treatment with CABOMETYX and for 4 months after the last dose.
Adverse Reactions: The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, nausea, decreased appetite, PPES, hypertension, vomiting, weight decreased, and constipation.
Drug Interactions: Strong CYP3A4 inhibitors and inducers: Reduce the dosage of CABOMETYX if concomitant use with strong CYP3A4 inhibitors cannot be avoided. Increase the dosage of CABOMETYX if concomitant use with strong CYP3A4 inducers cannot be avoided.
Lactation: Advise a lactating woman not to breastfeed during treatment with CABOMETYX and for 4 months after the final dose.
Reproductive Potential: Contraception―Advise females of reproductive potential to use effective contraception during treatment with CABOMETYX and for 4 months after the final dose. Infertility ―CABOMETYX may impair fertility in females and males of reproductive potential.
Hepatic Impairment: Reduce the CABOMETYX dose in patients with mild (Child-Pugh score [C-P] A) or moderate (C-P B) hepatic impairment. CABOMETYX is not recommended for use in patients with severe hepatic impairment.
Please see full Prescribing Information at View Source
Acceleron Announces Top-Line Results from DART Phase 2 Study of Dalantercept in Advanced Renal Cell Carcinoma
On June 12, 2017 Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics to treat serious and rare diseases, reported that the DART Phase 2 study of dalantercept plus axitinib did not achieve its primary endpoint in advanced renal cell carcinoma (RCC) (Press release, Acceleron Pharma, JUN 12, 2017, View Source [SID1234519496]). The primary efficacy endpoint of the study was to demonstrate a statistically significant increase in progression-free survival (PFS) for treatment of dalantercept plus axitinib versus placebo plus axitinib in advanced RCC patients.
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"We designed a robust Phase 2 study to evaluate the efficacy of dalantercept in combination with anti-VEGF therapy in advanced renal cell carcinoma patients whose disease has progressed on prior anti-VEGF therapy. We are disappointed by the results given the need for new agents that improve outcomes for patients with advanced RCC. We would like to thank the patients, caregivers, investigators, and our team who made the DART study possible," said Habib Dable, President and Chief Executive Officer of Acceleron. "Based on the lack of efficacy, we are discontinuing the development of dalantercept. We remain focused on the development of luspatercept across multiple Phase 3 and Phase 2 studies and ACE-083 across two neuromuscular diseases, and will continue to pursue additional candidates in areas of high unmet medical need."
The DART study enrolled 131 patients with advanced RCC. The efficacy data are based on the All-Treated Set (ATS) which is defined as all randomized patients who received any study drug (n=119) as of the database cutoff. In the ATS, 58 patients were randomized to dalantercept plus axitinib and 61 patients were randomized to placebo plus axitinib.
The median PFS for dalantercept plus axitinib was 6.8 months versus 5.6 months for placebo plus axitinib. Dalantercept plus axitinib did not decrease the rate of disease progression or death (HR 1.11, two-sided 95% CI [0.71, 1.73], one-sided p-value 0.67). The key secondary endpoint for the study was PFS for patients who received two or more prior systemic anti-cancer therapies. In this analysis, the median PFS for dalantercept plus axitinib was 8.1 months versus 7.0 months for placebo plus axitinib (HR 0.78, two-sided 95% CI [0.33, 1.87], one-sided p-value 0.29). The confirmed objective response rate (ORR) for dalantercept plus axitinib was 19% versus 25% for placebo plus axitinib (p-value 0.43, Cochran-Mantel-Haenszel test).
The safety data are based on the 119 ATS patients. The frequency of Grade 3 or higher adverse events (AEs) regardless of causality were similar overall in the dalantercept plus axitinib (59%) and the placebo plus axitinib (64%) study arms. The frequency of serious AEs of any grade regardless of causality were also similar in the dalantercept plus axitinib (29%) and the placebo plus axitinib (26%) study arms. The AEs associated with dalantercept were consistent with those previously observed.
About the DART Phase 2 Study
The Phase 2 DART clinical trial is a two-part study in patients with advanced renal cell carcinoma. Part 1 is a dose-escalation study of dalantercept plus axitinib to evaluate the safety and tolerability of the combination in patients whose disease has progressed following one to three lines of prior therapy. Part 2 is a randomized, double-blind study of 130 patients with advanced renal cell carcinoma who have progressed following treatment with a VEGF receptor tyrosine kinase inhibitor. Patients may have also received prior mTOR therapy and/or immunotherapy. For additional information on this clinical trial, please visit www.clinicaltrials.gov, identifier NCT01727336.
About Dalantercept
Dalantercept is an investigational protein therapeutic that inhibits angiogenesis by preventing BMP9, a protein in the transforming growth factor-beta (TGF-beta) superfamily, from interacting with activin receptor-like kinase 1 (ALK1), a cell-surface receptor found on proliferating vascular endothelial cells. Dalantercept inhibits ALK1 signaling, which is required for the development of mature, functional vasculature.
OncoSec Announces Technology Access Program Agreement with Jounce Therapeutics, Inc.
June 12, 2017 /PRNewswire/ — OncoSec Medical Incorporated ("OncoSec") (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported that they have engaged in a preclinical agreement through the OncoSec Technology Access Program (TAP) with Jounce Therapeutics, Inc., (NASDAQ:JNCE) Cambridge, MA, a company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers for patient enrichment. Schedule your 30 min Free 1stOncology Demo! Under the agreement, Jounce can utilize OncoSec’s gene delivery technology to evaluate in vivo efficacy in murine models of intratumorally-delivered therapeutic candidates. The agreement includes the GENESIS research generator and proprietary applicators developed for research use.
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"We are excited to provide a preclinical delivery solution to Jounce for early-stage research purposes and expand the data set from our delivery technologies through our Technology Access Program," said Punit Dhillon, CEO and President of OncoSec. "Through the establishment of these programs, OncoSec benefits from extensive, multi-party characterization and validation of our proprietary, state-of-the art electroporation technologies. We are pleased to be working with Jounce to help advance their preclinical programs with these technologies."
"OncoSec has developed a unique delivery technology that will enable us to rapidly assess potential candidates in preclinical models," said Debbie Law, Jounce’s Chief Scientific Officer. "We are delighted to be working with OncoSec and leveraging their technology to help us evaluate our preclinical immunotherapy programs."
About OncoSec Research Technologies and Technology Access Program:
The OncoSec GENESIS research generator was developed specifically for gene electro-transfer. It features customizable electroporation parameters for construct-specific optimization of expression, and it is the only in vivo electroporation device enabled with TRACE Technology (Tissue-Based, Real-Time Adaptive Control Electroporation.)
TRACE technology incorporates an electrochemical tissue-sensing control system to automatically adjust pulse width and treatment duration in real time during the electroporation procedure. This feature enables tissue- and therapeutic-specific delivery optimization, maximizing uptake of the therapeutic while reducing unnecessary cell ablation or damage. In research models, GENESIS with TRACE has yielded higher and more consistent in vivo protein expression versus fixed-parameter electroporation, even in heterogeneous tissues.
Potential advantages of GENESIS with TRACE for use in murine models include robust and conformationally-native in vivo expression of difficult proteins, including GPCRs and receptors that function in multimeric form. Moreover, the consistent results obtained with these technologies in heterogeneous tissues support reliable intratumoral delivery of a wide variety of DNA-encodable therapeutics across multiple syngeneic, xenograft, and PDX models. Using these technologies, OncoSec has expressed more than fifty proteins in vivo, including multimers and structurally-complex fusion proteins, and no protein tested to date has failed to successfully express.
The OncoSec Technology Access Program makes OncoSec’s electroporation technologies available to collaborators for preclinical research. Devices are available for intratumoral, intradermal, and intramuscular delivery. For more information, please contact [email protected].
For SEC reporting purposes, the agreement between OncoSec and Jounce is non-material.
Mateon Therapeutics Provides Update on its Clinical Trial Programs and Milestones
On June 12, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported an update regarding the current status of all clinical trials of its investigational drugs (Press release, Mateon Therapeutics, JUN 12, 2017, View Source [SID1234519489]).
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Company-sponsored studies:
FOCUS for platinum-resistant ovarian cancer
FOCUS is a phase 2/3 study in patients with platinum-resistant ovarian cancer, evaluating whether the addition of CA4P to the current standard-of-care (bevacizumab plus chemotherapy) improves progression-free survival. As of June 9, 2017, FOCUS has enrolled 57 patients in the United States, Germany and Belgium, with enrollment on-going at 37 sites. The second interim analysis, which will occur after the first 40 patients have been treated for at least two months or withdrawn from the study, remains on track to be completed in August 2017. Based on the number of patients enrolled and projected enrollment trends, the company expects the third interim analysis, representing 60 patients, to be completed in late September 2017.
OX1222 for acute myeloid leukemia
OX1222 is a dose-ascending phase 1b/2 clinical trial evaluating OXi4503 in combination with cytarabine in patients with recurrent/relapsed acute myeloid leukemia (AML). Mateon recently completed enrollment and treatment for the fourth cohort of 7.81 mg/m2 of OXi4503, and no dose limiting toxicities or significant safety issues were identified among the three patients. One patient treated in the fourth cohort experienced a significant AML blast reduction, with blast counts going from 89% upon enrollment to 7% following the first cycle of treatment. However, the patient subsequently experienced an unrelated adverse event and withdrew from the study approximately two weeks after the last dose of OXi4503 in the second cycle of treatment, prior to an additional blast measurement and accordingly did not meet the criteria for a complete remission. Three complete remissions were observed in the first three cohorts (19% overall in the clinical trial to date), each of which occurred after two cycles of treatment, and two complete remissions remain on-going at 12+ and 3+ months. Enrollment is on-going in the fifth cohort of 9.76 mg/m2 of OXi4503.
Investigator-sponsored studies:
PAZOFOS for recurrent ovarian cancer
The PAZOFOS study is a phase 1b/2 investigator-sponsored study being conducted in the U.K., evaluating the combination of CA4P and the TKI-inhibitor pazopanib for patients with advanced recurrent ovarian cancer. To date, the study has enrolled and treated 20 patients with CA4P and pazopanib in the phase 1b and phase 2 portions of the trial. The study sponsor, The Christie NHS Trust, has temporarily suspended enrollment in the trial in order to collect and review additional information on two recent serious adverse events – one patient in the study experienced hypertension and myocardial ischemia, and a second patient experienced chest pain. In both cases, the events were of short duration and the clinical symptoms resolved.
The label for pazopanib, which is not approved for the treatment of ovarian cancer in the U.S., contains warnings for cardiac dysfunction, arterial thrombotic events and hypertension. CA4P has been observed in most patients to cause an acute and transient increase in blood pressure following administration.
Following review of the data available for the patients in PAZOFOS, the company does not believe any changes or adjustments to Mateon’s FOCUS study are warranted. FOCUS has restrictive enrollment criteria for patients with pre-existing cardiovascular risk factors and specific algorithms for treatment of patients that experience blood pressure increases.
Neuroendocrine tumors
The Markey Cancer Center at the University of Kentucky recently began a phase 1 study evaluating the combination of CA4P and everolimus for the treatment of neuroendocrine tumors. In the first part of the study, patients are being treated with two different dosing regimens of CA4P in combination with everolimus to evaluate the safety of the drug combination and establish appropriate CA4P dosing levels.
"We are pleased that studies in both our core programs, the FOCUS study of CA4P for platinum-resistant ovarian cancer and Study OX1222 of OXi4503 for AML, are enrolling well and showing a good safety profile, as well as initial indications of efficacy," stated William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. "We are looking forward to data read outs from each of these studies later this summer."
"The investigator-sponsored PAZOFOS study, which uses CA4P with a different combination of drugs for recurrent ovarian cancer, also holds significant potential for patients and we’re hopeful that enrollment will resume soon," Dr. Schwieterman added.
AbbVie Announces New Data Evaluating Venetoclax in a Variety of Hematologic Malignancies at the 22nd European Hematology Association Congress
On June 12, 2017 AbbVie (NYSE: ABBV), a global biopharmaceutical company, reported that data from multiple clinical trials evaluating venetoclax, a first-in-class oral B-cell lymphoma-2 (BCL-2) inhibitor, will be presented at the 22nd European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, June 22-25, in Madrid (Press release, AbbVie, JUN 12, 2017, View Source [SID1234519487]). Investigational data will be presented from 15 studies evaluating venetoclax across some of the most common hematologic malignancies, including chronic lymphocytic leukemia, multiple myeloma, acute myeloid leukemia and non-Hodgkin lymphoma. Schedule your 30 min Free 1stOncology Demo! VENCLYXTO monotherapy is approved in the EU for the treatment of CLL in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor; and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.1 VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
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"AbbVie is committed to investigating the safety and efficacy of venetoclax. The data being presented at EHA (Free EHA Whitepaper) reinforce this commitment and underscore our mission to develop and deliver therapies that address unmet needs in a selected set of debilitating hematologic malignancies and have a remarkable impact on the lives of people affected by cancer," said Gary Gordon, M.D., Ph.D., vice president, oncology clinical development, AbbVie.
AbbVie abstracts:
Venetoclax in CLL
Venetoclax in relapsed/refractory chronic lymphocytic leukemia (CLL) with 17p deletion: outcome and correlation with minimal residual disease from the full population of the pivotal M13-982 trial; Stilgenbauer et al.; Abstract S771; Oral Presentation; Sunday, June 25, 2017; 8:30-8:45 a.m. CEST
Treatment and 17p deletion testing patterns in community practice for patients with chronic lymphocytic leukemia (CLL) in the United States; Kapustyan et al.; Abstract E1023; ePOSTER; Friday, June 23, 2017; 8:30 a.m. CEST
Durability of responses on continuous therapy and following drug cessation in deep responders with venetoclax and rituximab; Anderson et al.; Abstract P247; Poster Presentation; Friday, June 23, 2017; 5:15-6:45 p.m. CEST
Attainment of complete remission is significantly associated with longer survival outcomes in relapsed/refractory (R/R) CLL: a meta-analysis; Ektare et al.; Abstract E1037; ePOSTER; Friday, June 23, 2017; 8:30 a.m. CEST
Impact of venetoclax on the quality of life of CLL patients relapsed/refractory to B-cell receptor (BCR) signaling pathway inhibitor treatment; Wierda et al.; Abstract P728; Poster Presentation; Saturday, June 24, 2017; 5:30-7:00 p.m. CEST
Impact of venetoclax on the quality of life of patients with relapsed/refractory chronic lymphocytic leukemia: results of a Phase 2, open-label study of venetoclax (ABT-199/GDC-0199) monotherapy; Wierda et al.; Abstract E1466; ePOSTER; Friday, June 23, 2017 8:30 a.m. CEST
Reduced healthcare resource utilization in patients with chronic lymphocytic leukemia achieving complete remission to first-line therapy; Enschede et al.; Abstract E1035; ePOSTER; Friday, June 23, 2017; 8:30 a.m. CEST
Progression-free survival (PFS) and overall survival (OS) in patients with chronic lymphocytic leukemia (CLL) — clinical benefits of achieving a deep response to first-line therapy; Samp et al.; Abstract PB1791; Publication; Thursday, May 18, 2017; 12:00 p.m. CEST
Venetoclax in AML
Safety and efficacy of venetoclax (VEN) in combination with decitabine or azacitidine in treatment-naive, elderly patients (>=65 years) with acute myeloid leukemia (AML); Pratz et al.; Abstract S472; Oral Presentation; Saturday, June 24, 2017; 4:15-4:30 p.m. CEST
Updated safety and efficacy results of Phase 1/2 study of venetoclax plus low-dose cytarabine in treatment-naive acute myeloid leukemia patients aged >=65 years and unfit for standard induction therapy; Wei et al.; Abstract S473; Oral Presentation; Saturday, June 24, 2017; 4:30-4:45 p.m. CEST
Venetoclax in NHL/MM
A Phase 1 study evaluating the safety and pharmacokinetics of venetoclax in Japanese patients with non-Hodgkin lymphoma and multiple myeloma; Yamamoto et al.; Abstract E1139; ePOSTER; Friday, June 23, 2017; 8:30 a.m. CEST
Venetoclax in MM
A Phase 1b study of venetoclax combined with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma; Moreau et al.; Abstract s460; Oral Presentation; Saturday, June 24, 2017; 5:00-5:15 p.m. CEST
BCL2 expression is a potential predictive biomarker of response to venetoclax in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma; Ross et al.; Abstract P682; Poster Presentation; Saturday, June 24, 2017; 5:30-7:00 p.m. CEST
Venetoclax as targeted therapy for relapsed/refractory multiple myeloma; Kumar et al.; Abstract P675; Poster Presentation; Saturday, June 24, 2017; 5:30-7:00 p.m. CEST
Venetoclax in NHL
Venetoclax (VEN) in patients with relapsed/refractory non-Hodgkin lymphoma (NHL); Davids et al.; Abstract P564; Poster Presentation; Saturday, June 24, 2017; 5:30-7:00 p.m. CEST
The EHA (Free EHA Whitepaper) 2017 Annual Congress abstracts are available at www.ehaweb.org.