On May 9, 2017 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported financial results and recent highlights for the first quarter ended March 31, 2017 (Press release, Halozyme, MAY 9, 2017, View Source [SID1234518963]).

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"The first quarter was marked by strong progress in our ongoing clinical studies of PEGPH20 and continued momentum with partners of our ENHANZE technology," said Dr. Helen Torley, president and chief executive officer. "Enrollment is progressing to plan in HALO-301, our ongoing Phase 3 study of PEGPH20 in pancreas cancer patients and in the HALO-101 study of PEGPH20 in combination with KEYTRUDA in advanced gastric and non-small cell lung cancer patients, supporting the potential for first efficacy data in combination with a PD-1 inhibitor in the fourth quarter. In addition, we are delighted that our Phase 2 HALO-202 study was selected for an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

"At the same time, the outlook for our ENHANZE technology has never been stronger following the unanimous FDA advisory committee in March supporting rituximab SC. Our pipeline of active partner discussions has continued to expand, and while the timing for new ENHANZE collaboration agreements is unpredictable, it remains our goal to sign another agreement in 2017."

First Quarter 2017 and Recent Highlights include:

Acceptance of Halozyme’s Phase 2 randomized HALO-202 study data for an oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting. The presentation will expand on the topline results shared in January with additional data from the study as of December 2016.

Enrollment tracking to plan in HALO-301, the company’s Phase 3 study of pancreas cancer patients at over 200 global sites in 22 countries.

Progressing in the dose expansion phase of the ongoing Phase 1b clinical study evaluating PEGPH20 in combination with KEYTRUDA (pembrolizumab) in relapsed non-small cell lung and gastric cancer patients. Enrollment is progressing to plan and may enable Halozyme to report response rate data by the end of the year, depending on the pace of enrollment and time to response.

Presenting data showing PEGPH20 increases immune response and effectiveness of immunotherapies in preclinical animal models at the American Association of Cancer Research annual meeting. The research showed a significant increase in the accumulation of cancer-fighting CD8+ T cells in mice treated with PEGPH20, and that PEGPH20 increased the effectiveness of an anti-PD-L1 therapy by 411 percent compared to anti-PD-L1 alone as measured by tumor growth inhibition in an HA-rich mouse model.

Announcing an Oncologic Drug Advisory Committee of the U.S. Food and Drug Administration voted 11 to 0 that the benefit/risk of rituximab/hyaluronidase for subcutaneous injection was favorable for patients in the proposed indications of follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia. The FDA action date is June 26. Analysts estimate rituxumab sales in oncology indications in the United States were approximately $3 billion in 2016.

Advancing the development of multiple products using Halozyme’s ENHANZE technology. Roche continues in its ongoing Phase 1 study to examine the combination of Herceptin SC and a subcutaneous formulation of Perjeta using ENHANZE, including investigation into whether a single injection of the combination can be achieved, potentially providing a significant convenience for patients.

In addition, Janssen has developed a rapid delivery SC formulation of daratumumab using ENHANZE technology and recently dosed the first patients as part of their ongoing Phase 1 study. Janssen is currently planning to initiate a Phase 3 study using the new formulation later this year.

The collaboration with Lilly using Halozyme’s ENHANZE technology is progressing across multiple targets with preclinical and clinical studies this year and next.
First Quarter 2017 Financial Highlights

Revenue for the first quarter was $29.6 million compared to $42.5 million for the first quarter of 2016. The year-over-year decrease was driven by $15.5 million received in license and milestone payments from Lilly, AbbVie and Pfizer in the first quarter of 2016, partially offset by increases in royalties from partner sales of Herceptin SC, MabThera SC and HYQVIA, and research and development reimbursements from ENHANZE partners. Revenue for the first quarter included $14 million in royalties, an increase of 23 percent from the prior-year period, $8.2 million in sales of bulk rHuPH20 primarily for use in manufacturing collaboration products and $3.2 million in HYLENEX recombinant (hyaluronidase human injection) product sales.

Research and development expenses for the first quarter were $36.9 million, compared to $40.1 million for the first quarter of 2016. The decrease was driven by drug product purchases for the HALO-301 study as well as one-time costs related to companion diagnostic development.
Selling, general and administrative expenses for the first quarter were $12.6 million, compared to $10.8 million for the first quarter of 2016. The increase was primarily due to personnel expenses, including stock compensation, for the
period.

Net loss for the first quarter was $32.9 million, or $0.26 per share, compared to net loss in the first quarter of 2016 of $19.8 million, or $0.16 per share.
Cash, cash equivalents and marketable securities were $179 million at March 31, 2017, compared to $205 million at December 31, 2016.
Financial Outlook for 2017

For 2017, the company reiterated its financial guidance of:

Net revenue of $115 million to $130 million;
Operating expenses of $240 million to $250 million;
Operating cash burn of $75 million to $85 million; and
Year-end cash balance of $110 million to $125 million.

On May 9, 2017 Geron Corporation (Nasdaq:GERN) reported financial results for the first quarter ended March 31, 2017 and recent events (Press release, Geron, MAY 9, 2017, View Source [SID1234518962]).

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First Quarter 2017 Results

For the first quarter of 2017, the company reported operating revenues of $537,000 and operating expenses of $8.0 million compared to $749,000 and $9.8 million, respectively, for the comparable 2016 period. Revenues for the first quarter of 2017 and 2016 included royalty and license fee revenues under various non-imetelstat license agreements. Net loss for the first quarter of 2017 was $7.2 million, or $0.05 per share, compared to $8.8 million, or $0.06 per share, for the comparable 2016 period. The company ended the first quarter of 2017 with $121.7 million in cash and investments.

Research and development expenses for the three months ended March 31, 2017 and 2016 were $3.4 million and $5.0 million, respectively, and largely reflect the company’s proportionate share of clinical development expenses under the imetelstat collaboration with Janssen Biotech, Inc. (Janssen). Higher research and development expenses in 2016 were primarily due to start-up costs for the initiation of IMerge, the Phase 2/3 trial in myelodysplastic syndromes being conducted by Janssen, in which the first patient was dosed in January 2016.

General and administrative expenses for the three months ended March 31, 2017 and 2016 were $4.7 million and $4.8 million, respectively. The decrease in general and administrative expenses in 2017 compared to 2016 primarily reflects reduced consulting costs.

Interest and other income for the three months ended March 31, 2017 and 2016 were $332,000 and $256,000, respectively. The increase in interest and other income in 2017 compared to 2016 primarily reflects higher yields on the company’s marketable securities portfolio.

"As a result of the second internal data reviews that were completed in April for the imetelstat clinical trials in myelodysplastic syndromes and myelofibrosis, both trials are continuing unmodified. For IMerge, the next step is a decision regarding the Phase 3 portion of the trial. If Janssen decides to move forward, we expect the Phase 3 portion to be open to patient enrollment in the fourth quarter. For IMbark, we expect Janssen to evaluate maturing data from the trial during the next year, including an assessment of overall survival," said John A. Scarlett, M.D., Geron’s President and Chief Executive Officer. "We continue to be pleased by the commitment to imetelstat shown by our colleagues at Janssen. Their conduct of these internal data reviews has highlighted to us the care and professional development expertise they are applying to this innovative drug."

Recent Company Events

Imetelstat Clinical Development

The telomerase inhibitor imetelstat is being evaluated in two ongoing clinical trials, IMerge and IMbark, as conducted by Janssen under the terms of an exclusive worldwide license and collaboration agreement. IMerge is a Phase 2/3 clinical trial designed to evaluate imetelstat in transfusion dependent patients with IPSS low or intermediate-1 risk myelodysplastic syndromes (MDS) who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). IMbark is a Phase 2 clinical trial designed to evaluate two dose levels of imetelstat in patients with intermediate-2 or high risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a JAK inhibitor.

In April 2017, the second internal data reviews of IMerge and IMbark were completed. Based on these reviews, the Joint Steering Committee determined the following:

Both trials continue unmodified, and patients remaining in the treatment phases may continue to receive imetelstat.

The safety profile of imetelstat in both trials was consistent with prior clinical trials of imetelstat in hematologic malignancies, and no new safety signals were identified.

For IMerge, the benefit/risk profile of imetelstat in the Phase 2 patients supports continued development in lower risk MDS. A data package and proposed design refinements to the Phase 3 component of the trial are planned to be provided to the FDA. In addition, the Phase 2 data from IMerge are expected to be submitted for consideration for presentation at a medical conference in the future.

For IMbark, the current results suggest clinical benefit and a potential overall survival benefit associated with imetelstat treatment in relapsed or refractory MF. Enrollment of new patients to the trial remains suspended because the total number of patients enrolled to date is adequate to assess longer-term outcome measures, including overall survival, when the data are fully matured.
Geron expects further decisions by Janssen on the development of imetelstat will be informed by maturing efficacy and safety data from the trials, feedback from health authorities, and the totality of imetelstat program information, including an assessment of the evolving treatment landscapes in MDS and MF and the potential application of imetelstat in multiple hematologic malignancies.

Poster Presentation

Non-clinical data on imetelstat was presented as a poster by Janssen at the 2017 annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April:

Telomerase inhibitor imetelstat in combination with the BCL-2 inhibitor venetoclax enhances apoptosis in vitro and increases survival in vivo in acute myeloid leukemia (Abstract #1101)

Data presented described non-clinical results of imetelstat’s activity in combination with venetoclax, a selective BCL-2 inhibitor. In acute myeloid leukemia (AML) cell lines, telomerase expression and activity were decreased by imetelstat and further reduced in combination with venetoclax. In addition, imetelstat enhanced apoptosis induced by venetoclax in AML cell lines and AML patient samples. Combining imetelstat with venetoclax in an AML mouse model prolonged survival, with four of ten mice alive approximately 80 days after treatment was stopped.
The poster is available on Geron’s website at www.geron.com/presentations.

On May 9, 2017 Portola Pharmaceuticals Inc. (Nasdaq:PTLA) reported that clinical results from the Phase 2 study of cerdulatinib in patients with relapsed/refractory b-cell malignancies will be shared in an oral presentation at the International Conference on Malignant Lymphoma (ICML), which is taking place from June 14-17 in Lugano, Switzerland (Press release, Portola Pharmaceuticals, MAY 9, 2017, View Source [SID1234518957]).

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Cerdulatinib is an investigational oral, dual SYK/JAK kinase inhibitor in development to treat patients with resistant or relapsed hematologic cancers. Cerdulatinib inhibits two key signaling pathways that promote cancer cell growth in certain hematologic malignancies.
Details regarding the oral presentation follow.

Oral Presentation Details:

Abstract Title: The Dual SYK/JAK Inhibitor Cerdulatinib Demonstrates Rapid Tumor Responses in a Phase 2 Study in Patients with Relapsed/Refractory B-Cell Malignancies
Presenting Author: P.A. Hamlin, Memorial Sloan Kettering Cancer Center
Presentation Date and Time: June 15, 2017 at 4:40 p.m. CEST
Location: Room A, Cinema Corso and Aula Magna (Lugano University)

On May 9, 2017 EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. (NYSE: PFE) reported that the US Food and Drug Administration (FDA) has approved BAVENCIO (avelumab) Injection for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy (Press release, Pfizer, MAY 9, 2017, View Source [SID1234518956]). BAVENCIO was previously granted accelerated approval from the FDA for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). These indications are approved under accelerated approval based on tumor response and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

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"This approval for BAVENCIO in patients with locally advanced or metastatic urothelial carcinoma exemplifies our unwavering commitment to finding new treatments for the most challenging cancers," said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany. "Coming just a few weeks after the approval for metastatic Merkel cell carcinoma, we continue to demonstrate our ability to accelerate access to innovative medicines for patients in need."

"This approval builds on the ongoing clinical development program for BAVENCIO in urothelial carcinoma and reinforces our commitment to providing new medicines to patients with difficult-to-treat cancers," said Liz Barrett, Global President, Pfizer Oncology. "By drawing on the strength of the alliance, as well as Pfizer’s deep experience in genitourinary cancers, we believe BAVENCIO will be an important treatment option, and we hope it will help to improve outcomes for these patients."

Bladder cancer makes up approximately 90% of urothelial carcinomas and is the sixth most common cancer in the US.2,3 When the disease has metastasized, the five-year survival rate is approximately 5%.4 Despite advances in the treatment of locally advanced or metastatic urothelial carcinoma, the prognosis for patients remains poor and more treatment options are needed.2

"Once urothelial carcinoma progresses after treatment with chemotherapy, the five-year survival rate is alarmingly low," said Dr. Andrea Apolo, National Cancer Institute, Bethesda, MD, US. "Until recently, there had been limited innovation in urothelial carcinoma, and this approval gives us another treatment to help battle this aggressive disease."

The efficacy and safety of BAVENCIO was demonstrated in the urothelial carcinoma cohorts (N=242) of the JAVELIN Solid Tumor trial, a Phase I, open-label, single-arm, multicenter study of BAVENCIO in the treatment of various solid tumors. The urothelial carcinoma cohorts enrolled patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy or who had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen. These data will be presented at an upcoming medical congress.

The warnings and precautions for BAVENCIO include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions), infusion-related reactions and embryo-fetal toxicity. The most common adverse reactions (reported in at least 20% of patients) in patients with locally advanced or metastatic urothelial carcinoma were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%) and urinary tract infection (21%).1 For more information, please see Important Safety Information for BAVENCIO below.

BAVENCIO is designed to potentially engage both the adaptive and innate immune systems. By binding to PD-L1, BAVENCIO is thought to prevent tumor cells from using PD-L1 for protection against white blood cells, such as T cells, exposing them to anti-tumor responses.1 BAVENCIO has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.1

The alliance is committed to providing industry-leading patient access and reimbursement support through its CoverOne program. This program provides a spectrum of patient access and reimbursement support services intended to help patients receive appropriate access to BAVENCIO in the United States. CoverOne may be reached by phone at 844-8COVER1 (844-826-8371) or online at www.CoverOne.com.

About Urothelial Carcinoma Cohorts in JAVELIN Solid Tumor Trial The efficacy and safety of BAVENCIO was demonstrated in the urothelial carcinoma cohorts of the JAVELIN Solid Tumor trial, a Phase I, open-label, single-arm, multicenter study that included 242 patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum- containing chemotherapy or who had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen who were treated with BAVENCIO.

Patients with active or a history of central nervous system metastasis; other malignancies within the last five years; an organ transplant; conditions requiring therapeutic immune suppression; or active infection with HIV, hepatitis B or C were excluded. Patients with autoimmune disease, other than type 1 diabetes, vitiligo, psoriasis, or thyroid disease that did not require immunosuppressive treatment, were excluded. Patients were included regardless of their PD-L1 status. Patients received BAVENCIO at a dose of 10 mg/kg intravenously over 60 minutes every two weeks until disease progression or unacceptable toxicity. Tumor response assessments were performed every six weeks, as assessed by an Independent Endpoint Review Committee (IERC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Efficacy outcome measures included confirmed overall response rate, (ORR) and duration of response (DOR). Efficacy measures were evaluated in patients who were followed for a minimum of both 13 weeks and 6 months at the time of data cut-off.

Out of the total 226 patients evaluable for efficacy, 44% had non-bladder urothelial carcinoma, including 23% of patients with upper tract disease; 83% of patients had visceral metastases; 34% of patients had liver metastases. Nine patients (4%) had disease progression following prior platinum-containing neoadjuvant or adjuvant therapy only. Forty-seven percent of patients only received prior cisplatin-based regimens, 32% received only prior carboplatin-based regimens, and 20% received both cisplatin and carboplatin-based regimens.

The international clinical development program for avelumab, known as JAVELIN, involves more than 30 clinical programs, including nine Phase III trials, and more than 5,200 patients across more than 15 tumor types.

In December 2015, Merck KGaA, Darmstadt, Germany and Pfizer announced the initiation of a Phase III multicenter, multinational, randomized, open-label, parallel-arm study (JAVELIN Bladder 100) of BAVENCIO plus best supportive care versus best supportive care alone as a maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma whose disease did not progress after completion of first-line platinum-containing chemotherapy. This trial is currently enrolling patients.

For more information about JAVELIN trials, please visit www.clinicaltrials.gov.

For full prescribing information and medication guide for BAVENCIO, please see www.BAVENCIO.com.

IMPORTANT SAFETY INFORMATION and INDICATIONS

BAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% (21/1738) of patients, including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3.

BAVENCIO can cause immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis was reported in 0.9% (16/1738) of patients, including two (0.1%) patients with Grade 5 and 11 (0.6%) with Grade 3.

BAVENCIO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis and permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon re-initiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% (26/1738) of patients, including seven (0.4%) with Grade 3.

BAVENCIO can cause immune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus.

Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% (8/1738) of patients, including one (0.1%) with Grade 3.

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. Manage hypothyroidism with hormone replacement therapy and hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life- threatening (Grade 4) thyroid disorders. Thyroid disorders including hypothyroidism, hyperthyroidism, and thyroiditis were reported in 6% (98/1738) of patients, including three (0.2%) with Grade 3.

Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer anti-hyperglycemics or insulin in patients with severe or life-threatening (Grade ≥ 3) hyperglycemia, and resume treatment when metabolic control is achieved. Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% (2/1738) of patients, including two cases of Grade 3 hyperglycemia.

BAVENCIO can cause immune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower. Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% (1/1738) of patients.

BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation. For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes. Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy if appropriate. Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper. Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO: myocarditis with fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barré syndrome, and systemic inflammatory response.

BAVENCIO can cause severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Patients should be premedicated with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent doses based upon clinical judgment and presence/severity of prior infusion reactions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Infusion-related reactions occurred in 25% (439/1738) of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3.

BAVENCIO can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death. Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk. Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants.

The most common adverse reactions (all grades, ≥ 20%) in patients with metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%).

Selected treatment-emergent laboratory abnormalities (all grades, ≥ 20%) in patients with metastatic MCC were lymphopenia (49%), anemia (35%), increased aspartate aminotransferase (34%), thrombocytopenia (27%), and increased alanine aminotransferase (20%).

The most common adverse reactions (all grades, ≥ 20%) in patients with locally advanced or metastatic urothelial cancer (UC) were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%) and urinary tract infection (21%).

Selected laboratory abnormalities (grades 3-4, ≥ 3%) in patients with locally advanced or metastatic UC were hyponatremia (16%), gamma-glutamyltransferase increased (12%), lymphopenia (11%), hyperglycemia (9%), increased alkaline phosphatase (7%), anemia (6%), increased lipase (6%), hyperkalemia (3%), and increased aspartate aminotransferase (3%).

INDICATIONS

BAVENCIO is indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).

BAVENCIO is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

These indications are approved under accelerated approval based on tumor response and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Please see full Prescribing Information and Medication Guide.

Avelumab has not yet been approved for any indication in any market outside of the US. As announced on October 31, 2016, the European Medicines Agency (EMA) has validated for review Merck KGaA, Darmstadt, Germany’s Marketing Authorization Application for avelumab, for the proposed indication of metastatic Merkel cell carcinoma.

About BAVENCIO (avelumab) BAVENCIO is a human programmed death ligand-1 (PD-L1) blocking antibody indicated in the US for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, as well as for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma.1 These indications are approved under accelerated approval based on tumor response and duration of response. Continued approval for these indications is contingent upon verification and description of clinical benefit in confirmatory trials.

BAVENCIO is not approved for any indication in any market outside the US.