On August 10, 2015 TG Therapeutics, Inc. (NASDAQ:TGTX) reported its financial results for the second quarter ended June 30, 2015 and recent company developments (Filing, 8-K, Manhattan Pharmaceuticals, AUG 10, 2015, View Source [SID:1234507159]).

Michael S. Weiss, the Company’s Executive Chairman and Interim Chief Executive Officer, stated, "The second quarter was a busy and exciting time for the Company, as the data presentations made during the quarter continue to reinforce our belief that the safety and efficacy profiles of TG-1101 and TGR-1202, alone or in combination together in our "1303" regimen, allow for safe and efficacious multiple drug regimens, which we firmly believe is the future of patient care in the treatment of B-cell malignancies. We remain focused on commencing additional combination registration trials in the coming months, and aggressively recruiting into our ongoing GENUINE Phase 3 clinical trial." Mr. Weiss continued, "From a financial perspective, with cash on hand of more than $125 million on a pro forma basis, we are well positioned to execute on our goals and bring the Company to substantial value creating milestones."

Recent Developments and Highlights

· Clinical data on the combination of TG-1101 and TGR-1202 was presented at the 51st American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held in Chicago, Illinois, as well as in poster presentations at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting held in Vienna, Austria and the International Congress on Malignant Lymphoma (ICML), held in Lugano, Switzerland

· Single agent clinical data for TGR-1202 was presented at the ASCO (Free ASCO Whitepaper) Annual Meeting, as well as in oral presentations at the EHA (Free EHA Whitepaper) and Lugano ICML meetings

· Clinical data on the triple combination of TG-1101, TGR-1202, and ibrutinib was presented in an oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting, and in an oral presentation at the Lugano ICML meeting

· Updated results from a Phase 2 clinical trial of TG-1101 in combination with ibrutinib in relapsed/refractory Chronic Lymphocytic Leukemia (CLL) was presented in an oral presentation at the Lugano ICML meeting

· Presently have over 120 sites open for the Company’s GENUINE Phase 3 Clinical Trial of TG-1101 in combination with ibrutinib in patients with High-Risk Chronic Lymphocytic Leukemia

Reaffirming 2015 Milestones

· Continue to aggressively recruit into the GENUINE Phase 3 Clinical Trial of TG-1101 in combination with ibrutinib

· Commence additional combination Phase 3 clinical trials, particularly for the Company’s proprietary "1303" combination of TG-1101 plus TGR-1202 in patients with Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin’s Lymphoma (NHL)

· Launch new triple therapy combination trials in addition to the currently enrolling Phase 1/2 trial of TG-1101 plus TGR-1202 plus ibrutinib

· Continue to push forward our preclinical development programs, including the IRAK4, anti-PD-L1, and anti-GITR programs, as well as opportunistically seek to identify drug candidates with complimentary mechanisms of action

· Commence clinical development program for the treatment of autoimmune diseases

· Present updated data on Phase 1 and 2 clinical trials at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, in December 2015, held in Orlando, Florida

Financial Results for the Second Quarter 2015

At June 30, 2015 the Company had cash, cash equivalents, investment securities, and interest receivable of $110.6 million, which includes approximately $51.2 million of net proceeds from the utilization of the Company’s at-the-market ("ATM") sales facility during the year (approximately $42 million of which was previously disclosed in connection with our last quarterly update), as compared to December 31, 2014 when we had $78.9 million.

Pro-forma cash, cash equivalents, investment securities, and interest receivable as of June 30, 2015 are approximately $126.4 million, including $15.8 million of net proceeds from the utilization of the ATM sales facility during the third quarter of 2015.

Our consolidated net loss for the second quarter ended June 30, 2015, excluding non-cash items, was approximately $10.9 million, which included approximately $4.8 million of manufacturing and CMC expenses in preparation for Phase 3 clinical trials and commercialization. The consolidated net loss for the second quarter ended June 30, 2015, inclusive of non-cash items, was $17.1 million, or $0.38 per diluted share, compared to a consolidated net loss of $12.0 during the comparable quarter in 2014, representing an increase in consolidated net loss of $5.1 million. The increase in consolidated net loss during the second quarter ended June 30, 2015 was primarily the result of other research and development expenses for TG-1101 and TGR-1202 increasing approximately $5.8 million and $1.3 million, respectively, over the comparable period in 2014. The increase in other research and development expenses related to TG-1101 was primarily the result of increased manufacturing and clinical trial expenses related to ongoing and planned future Phase 3 registration programs. These increases were partially offset by the $1.2 million of non-cash stock expense recorded in conjunction with the license to the IRAK4 inhibitors program during the quarter ended June 30, 2014 and a decrease of $1.5 million in non-cash compensation expense related to equity incentive grants over the comparable period in 2014.

Our consolidated net loss for the six months ended June 30, 2015, excluding non-cash items, was approximately $20.1 million, which included approximately $9.1 million of manufacturing and CMC expenses in preparation for Phase 3 clinical trials and commercialization. The consolidated net loss for the six months ended June 30, 2015, inclusive of non-cash items, was $31.7 million, or $0.73 per diluted share, compared to a consolidated net loss of $19.5 million during the comparable period in 2014, representing an increase in consolidated net loss of $12.2 million. The increase in consolidated net loss during the six months ended June 30, 2015 was primarily the result of other research and development expenses for TG-1101 and TGR-1202 increasing approximately $9.8 million and $2.5 million, respectively, over the comparable period in 2014. The increase in other research and development expenses related to TG-1101 was primarily the result of increased manufacturing and clinical trial expenses related to ongoing and planned future Phase 3 registration programs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(Filing, 10-Q, Merrimack, AUG 10, 2015, View Source [SID:1234507171])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On August 10, 2015 AVEO Oncology (NASDAQ:AVEO) reported financial results for the second quarter ended June 30, 2015 (Press release, AVEO, AUG 10, 2015, View Source;p=RssLanding&cat=news&id=2078276 [SID:1234507127]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The second quarter was productive on multiple fronts for AVEO, including clinical updates, regulatory guidance and another partnership for tivozanib, in addition to completion of our corporate streamlining efforts," said Michael Bailey, president and chief executive officer. "These accomplishments have positioned us well to continue pursuing several additional value creating initiatives for tivozanib, including a potential confirmatory clinical and regulatory path forward for renal cell cancer in the US, as well as a potential marketing authorization application for renal cell cancer in Europe. We remain focused on executing against these goals as we continue to evaluate additional portfolio partnerships and further tivozanib development in colorectal cancer, throughout the balance of the year."

Recent Highlights

Announces Exclusive Licensing Agreement with Pharmstandard for Tivozanib in Russia, Ukraine and CIS. In August, AVEO announced that it has entered into an exclusive license agreement with a subsidiary of Pharmstandard Group for the development, manufacturing and commercialization of tivozanib in the territories of Russia, Ukraine and the Commonwealth of Independent States, for all indications excluding non-oncology ocular conditions. Under the terms of the agreement, Pharmstandard is obligated to pay AVEO an upfront payment of $1.5 million. AVEO is also eligible to receive up to $7.5 million in connection with the first marketing authorization of tivozanib in Russia, $3.0 million for each additional approved indication thereafter and a high single-digit royalty on net sales in the above mentioned territories. Pharmstandard will be responsible for all activities and costs associated with the further development, regulatory filings, health services and commercialization of tivozanib in the specified territories. A percentage of all upfront, milestone and royalty payments received by AVEO are due to Kyowa Hakko Kirin as a sublicensing fee.
Presented Additional Biomarker Analyses from BATON-CRC Tivozanib Study—At the ESMO (Free ESMO Whitepaper) 17th World Congress on Gastrointestinal Cancer in July, AVEO presented additional biomarker analyses from the BATON-CRC tivozanib study, the Company’s Phase 2 clinical trial of modified FOLFOX6 combined with tivozanib or bevacizumab in metastatic colorectal cancer (CRC). The data were presented in a poster discussion titled "Neuropilin 1 (NRP1) may be Prognostic and Identify a Subgroup of Patients with Metastatic Colorectal Cancer (mCRC) who Benefit from Tivozanib + mFOLFOX6 compared to Bevacizumab + mFOLFOX6."

Received European Regulatory Guidance Regarding Potential Marketing Authorization Application for Tivozanib in RCC—In June, AVEO announced that, following pre-submission advisory meetings to discuss the potential submission of a Marketing Authorization Application (MAA) for tivozanib as a treatment for Renal Cell Carcinoma (RCC) in Europe, it had received written guidance from the Rapporteur and co-Rapporteur appointed by the Committee for Medicinal Products for Human Use for the filing of such an application. The application would be based on the Company’s existing dataset, which includes results from the Phase 3 TIVO-1 study of tivozanib in the first-line treatment of RCC in which tivozanib demonstrated a significant improvement over sorafenib in the study’s primary endpoint of progression free survival. The Company is evaluating partnership opportunities to take tivozanib forward in Europe as it continues to prepare for an MAA filing.

Presented Final Results of Extension Study 902 of Tivozanib in RCC—At the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June, AVEO presented final results from its TIVO-1 extension study, known as Study 902, in which patients with advanced RCC received tivozanib as second-line treatment subsequent to disease progression on sorafenib in the Company’s Phase 3 TIVO-1 first-line RCC study. The results were presented in a poster presentation titled "Tivozanib vs sorafenib targeted therapy for advanced renal cell carcinoma: Final results of a phase III trial (901) and efficacy results of a 2nd line tivozanib extension study (902)."

Received FDA Regulatory Guidance Regarding Proposed Phase 3 RCC Study—In May, AVEO announced it had received a written response from the FDA stating that a Phase 3 study outlined by the Company, in patients with RCC who have failed at least two prior regimens, including VEGF therapy, "may support AVEO’s proposed indication for tivozanib in the 3rd line setting." In response to whether the study, together with the TIVO-1 study, would be sufficient to also support licensure of tivozanib as a treatment for advanced [first line] RCC, the FDA indicated: "whether the results from this [third line] study can support AVEO’s proposal for tivozanib in the first line setting is a review issue." The Company continues to evaluate all options, including partnerships, for the clinical and regulatory advancement for tivozanib in RCC.

Received FDA Feedback for Tivozanib in CRC—In June, AVEO announced that it had received feedback from the U.S. Food and Drug Administration (FDA) regarding a potential pivotal study for tivozanib in the treatment of NRP-1 low (below the median, representing 50% of the population) CRC. This feedback is consistent with the Company’s current clinical strategy and discussions with cancer research cooperative groups. As such, AVEO plans to identify a commercially viable assay which will enable a prospectively defined, randomized Phase 2 study.

Relocated Corporate Headquarters—In May, AVEO announced the relocation of its corporate headquarters to One Broadway in Cambridge, Massachusetts. Consistent with the Company’s goal of streamlining operations to align with its strategic needs going forward, the new facility consists of approximately 5,000 square feet of office space under flexible lease terms, with no laboratory or vivarium space.

Presented AV-380 Preclinical Data in Cancer Associated Cachexia – At the 2015 Annual Meeting of the American Association of Cancer Research in April, AVEO presented results from a preclinical study of AV-380, the Company’s potent, humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), in a cachectic human tumor xenograft model with significantly increased plasma GDF15 levels. The data were presented in a poster titled "Effective treatment of cancer associated cachexia by AV-380, a GDF15 inhibitory antibody".

Second Quarter 2015 Financial Highlights

AVEO ended Q2 2015 with $26.8 million in cash and cash equivalents.
Total collaboration revenue was approximately $0.1 million compared with $1.8 million for Q2 2014. The decrease was primarily due to an additional $1.8 million in revenue recognized in connection with our agreement with Astellas, which concluded in August 2014.

Research and development (R&D) expense was $1.8 million compared with $9.3 million for Q2 2014. The decrease in R&D expense was primarily due to a reduction in personnel-related expenses following our January 2015 strategic restructuring, the reduction of our leased facilities, as well as a decrease in external clinical trial and consulting costs associated with the decreased tivozanib clinical development activity and AV-380 preclinical development activity.

General and administrative (G&A) expense was $2.9 million compared with $4.8 million for Q2 2014. The decrease in G&A expense was primarily due to a reduction in external legal costs associated with various ongoing legal matters and a decrease in employee compensation, facilities and IT costs following our January 2015 restructuring and the reduction of our leased facilities.
Restructuring and lease exit expense was $25,000 compared with $5.2 million for Q2 2014. The expense incurred during Q2 2015 related to accretion expense associated with the lease termination liability for the 650 E. Kendall Street facility, whereas the expense incurred during Q2 2014 related to the portion of the 650 E. Kendall Street facility that we ceased using during that quarter.

Net loss for Q2 2015 was $5.5 million, or a loss of $0.10 per basic and diluted net loss per share compared with net loss of $18.0 million or a loss of $0.35 per basic and diluted net loss per share for Q2 2014.

Financial Guidance

We believe that our cash resources will allow us to fund our current operations at least through the third quarter of 2016. This estimate does not include our payment of potential licensing milestones or the costs of conducting any contemplated clinical trials and assumes no milestone payments from our partners, additional funding from new partnership agreements, equity financings, debt financings or accelerated repayment thereof or further sales under our ATM. The timing and nature of activities contemplated for 2015 and 2016 will be conducted subject to the availability of sufficient financial resources.

On August 10, 2015 Immune Design (Nasdaq: IMDZ) reported it has entered into clinical collaboration agreements through subsidiaries of Merck (NYSE:MRK), known as MSD outside of the United States and Canada, to evaluate the safety and efficacy of two Immune Design immuno-oncology investigative agents, G100 and LV305, separately combined with KEYTRUDA(pembrolizumab), Merck’s anti-PD-1therapy, in Phase 1 trials in patients with non-Hodgkin’s lymphoma (NHL) and melanoma, respectively (Press release, Merck & Co, AUG 10, 2015, View Source [SID:1234507161]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The first clinical trial will examine intratumoral administration of G100 with intravenous administration of KEYTRUDA in patients with follicular NHL receiving local radiation. In addition to an evaluation of the safety of the combination, the study will assess the response in both injected and non-injected lesions. The second clinical trial in melanoma will evaluate safety and response to the combination of LV305 and KEYTRUDA in patients who have not yet responded to treatment with KEYTRUDA alone after three months of treatment.

Immune Design’s G100 and LV305 investigational agents are designed to work in vivo and activate the immune system via the induction and/or expansion of anti-tumor CD8 T cells. They are intended to be "off-the-shelf" therapies, in contrast to other T-cell approaches that require individualized ex vivo manipulation. G100 is a potent toll-like receptor-4 (TLR4) agonist designed to generate a robust anti-tumor immune response when administered directly to the tumor micro-environment. LV305, in contrast, is designed to activate the immune system through the in vivo generation of cytotoxic T cells (CTLs), initially against a specific tumor-associated antigen, NY-ESO-1. Immune Design is studying LV305 primarily as part of CMB305, a prime boost approach currently in a Phase 1 expansion trial.

"There is great potential to expand the potential of immunotherapy through combination approaches that will stimulate and enhance the immune system in order to mount the strongest response against cancer," said Carlos Paya, M.D., Ph.D, President and Chief Executive Officer of Immune Design. "Immune Design has two distinct approaches in oncology, and we look forward to collaborating with Merck to evaluate the potential of combining each of G100 and LV305 with KEYTRUDA in these areas of medical need."

"Our understanding of the immune system’s role and its impact in the treatment of cancer continues to grow," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "This collaboration with Immune Design adds to a broad clinical program designed to explore the role of KEYTRUDA in innovative immuno-oncology combinations – and underscores our commitment to advance the care of patients with cancer."

About G100

G100 is a product candidate generated from the company’s GLAASTM discovery platform, and includes a specific formulation of Glucopyranosyl Lipid A (GLA), a synthetic, toll-like Receptor-4 (TLR-4) agonist. G100 is part of Immune Design’s intratumoral immune activation, or ‘Endogenous Antigen’ approach to treating cancer, which leverages the activation of dendritic cells, T cells and other immune cells in the tumor microenvironment to potentially create a robust immune response against the tumor’s preexisting diverse set of antigens. Preclinical and clinical data have demonstrated the ability of G100 to activate dendritic cells in tumors and to increase antigen-dependent systemic humoral and cellular Th1 immune responses. In addition to the study planned under this collaboration, a Phase 1 study of G100 in patients with Merkel cell carcinoma (MCC) recently completed enrollment, and Immune Design presented data at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the poster for which can be accessed on the company’s website. In the first eight patients in MCC study, G100 has an acceptable safety profile and a fifty percent (50%) objective response rate per protocol.

About LV305

LV305, generated from Immune Design’s ZVexTM platform, is designed to activate the immune system through the in vivo generation of cytotoxic T cells (CTLs) initially against a specific tumor-associated antigen, NY-ESO-1. LV305 is part of Immune Design’s ‘Specific Antigen’ approach, which drives the in vivo generation of a strong, antigen-specific CTL response against selected antigens present in a tumor. Preclinical tests have demonstrated the ability of LV305 to reduce tumor growth of NY-ESO-1-expressing tumors, increase production of antigen-specific CD8 cells, and significantly improve the survival of tumor-bearing animals. LV305 is the first step in Immune Design’s novel prime-boost approach to immuno-oncology, which includes combination with G305, generated from the GLAAS platform, to expand CTLs and potentially generate a potent, durable immune response. Immune Design announced positive data from a Phase 1 study of LV305 at the 2015 ASCO (Free ASCO Whitepaper) Annual Meeting, the poster for which can be accessed on the company’s website. In that study, LV305 caused either a de novo or statistically-significant increase in antigen-specific CD8 T cells in 80% of the six evaluable mid- and high-dose patients. Immune Design is primarily studying LV305 as part of CMB305, a prime boost approach.

About KEYTRUDA (pembrolizumab)

KEYTRUDA (pembrolizumab) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, KEYTRUDA releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

KEYTRUDA is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merck is advancing a broad and fast-growing clinical development program for KEYTRUDA with more than 100 clinical trials – across more than 30 tumor types and over 16,000 patients – both as a monotherapy and in combination with other therapies.

Selected Important Safety Information for KEYTRUDA

Pneumonitis occurred in 12 (2.9%) of 411 patients with advanced melanoma receiving KEYTRUDA (the approved indication in the United States), including Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%) patients, respectively. Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 pneumonitis.

Colitis (including microscopic colitis) occurred in 4 (1%) of 411 patients, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%) patients respectively, receiving KEYTRUDA. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%) of 411 patients, including a Grade 4 case in 1 (0.2%) patient, receiving KEYTRUDA. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hypophysitis occurred in 2 (0.5%) of 411 patients, including a Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each) patient, receiving KEYTRUDA. Monitor for signs and symptoms of hypophysitis (including hypopituitarism and renal insufficiency). Administer corticosteroids for Grade 2 or greater hypophysitis. Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3; and permanently discontinue KEYTRUDA for Grade 4 hypophysitis.

Hyperthyroidism occurred in 5 (1.2%) of 411 patients, including Grade 2 or 3 cases in 2 (0.5%) and 1 (0.2%) patients, respectively, receiving KEYTRUDA. Hypothyroidism occurred in 34 (8.3%) of 411 patients, including a Grade 3 case in 1 (0.2%) patient, receiving KEYTRUDA. Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer corticosteroids for Grade 3 or greater hyperthyroidism. Withhold KEYTRUDA for Grade 3; permanently discontinue KEYTRUDA for Grade 4 hyperthyroidism. Isolated hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids.

Type 1 diabetes mellitus, including diabetic ketoacidosis, has occurred in patients receiving KEYTRUDA. Monitor patients for hyperglycemia and other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA in cases of severe hyperglycemia until metabolic control is achieved.

Nephritis occurred in 3 (0.7%) patients receiving KEYTRUDA, consisting of one case of Grade 2 autoimmune nephritis (0.2%) and two cases of interstitial nephritis with renal failure (0.5%), one Grade 3 and one Grade 4. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.

Other clinically important immune-mediated adverse reactions can occur. The following clinically significant, immune-mediated adverse reactions occurred in patients treated with KEYTRUDA: exfoliative dermatitis, uveitis, arthritis, myositis, pancreatitis, hemolytic anemia, partial seizures arising in a patient with inflammatory foci in brain parenchyma, severe dermatitis including bullous pemphigoid, myasthenic syndrome, optic neuritis, and rhabdomyolysis.

For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement of the adverse reaction to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Restart KEYTRUDA if the adverse reaction remains at Grade 1 or less. Permanently discontinue KEYTRUDA for any severe or Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

Infusion-related reactions, including severe and life-threatening reactions, have occurred in patients receiving KEYTRUDA. Monitor patients for signs and symptoms of infusion-related reactions including rigors, chills, wheezing, pruritis, flushing, rash, hypotension, hypoxemia, and fever. For severe or life-threatening reactions, stop infusion and permanently discontinue KEYTRUDA.

Based on its mechanism of action, KEYTRUDA may cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.

For the treatment of advanced melanoma, KEYTRUDA was discontinued for adverse reactions in 9% of 411 patients across all doses studied. Serious adverse reactions occurred in 36% of patients receiving KEYTRUDA. The most frequent serious adverse drug reactions reported in 2% or more of patients were renal failure, dyspnea, pneumonia, and cellulitis.

The most common adverse reactions (reported in at least 20% of patients) were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash (29%), decreased appetite (26%), constipation (21%), arthralgia (20%), and diarrhea (20%).

The recommended dose of KEYTRUDA is 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks until disease progression or unacceptable toxicity. No formal pharmacokinetic drug interaction studies have been conducted with KEYTRUDA. It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA. Safety and effectiveness of KEYTRUDA have not been established in pediatric patients.

(Filing, 10-Q, Fortress Biotech, AUG 10, 2015, View Source [SID:1234507138])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!