On September 27, 2017 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported an overview of the comprehensive immune monitoring data from the Phase 2 Investigator Sponsored Trial led by the University of California, San Francisco (UCSF) at the 2nd World Congress on Electroporation and Pulsed Electric Fields in Biology, Medicine and Food & Environmental Technologies in Norfolk, VA (Press release, OncoSec Medical, SEP 27, 2017, View Source [SID1234520665]). The trial assessed the combination of ImmunoPulse IL-12 and the approved anti-PD-1 therapy pembrolizumab in patients with unresectable metastatic melanoma and its ability to convert “cold” to “hot” tumors.

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In a plenary lecture entitled: “In situ priming with concurrent immune checkpoint inhibition: A phase 2 clinical trial of intratumoral plasmid IL-12 with electroporation in combination with pembrolizumab,” Alain Algazi, MD, Principal Investigator from UCSF, will discuss the clinical data presented at ASCO (Free ASCO Whitepaper)-SITC earlier this year, demonstrating that ImmunoPulse IL-12 in combination with pembrolizumab is well-tolerated and yields clinically meaningful synergy in immunologically “cold” tumors. Furthermore, translational data will be shown that suggest that therapeutic strategies depleting regulatory T-cells may enhance anti-tumor immunity potentially leading to additional improvements in objective response rates (ORR).

“These data support our planned phase 2b registration-directed trial, PISCES, which is designed to demonstrate that the combination of ImmunoPulse IL-12 and pembrolizumab provides an opportunity to address the resistance to anti-PD-1 therapy in the melanoma patient population,” said Punit Dhillon, CEO and President at OncoSec. “Patients with metastatic melanoma who are progressing or have progressed on anti-PD-1 therapy have limited treatment options and we look forward to presenting further data from our recently completed trials at a future medical conference later this year.”

Earlier in the week, Adil Daud, MD, Chief Clinical Strategist at OncoSec and Professor of Medicine at the University of California, San Francisco, gave an oral presentation at the 2nd World Congress of Electroporation titled, “Local and Systemic Immunotherapy by Electroporation,” which provided an overview of the development of OncoSec’s Phase 2 clinical studies assessing ImmunoPulse IL-12 as a monotherapy in patients with metastatic melanoma.

Shawna Shirley, Ph.D., Senior Scientist at OncoSec, also gave an oral presentation at the 2nd World Congress of Electroporation entitled, “Intratumoral Electroporation of Plasmid IL-12 Using Modified Parameters and an Optimized DNA Plasmid Increases Immunogenicity in Untreated Lesions in Mice,” which provided an overview of the improved preclinical efficacy using an optimized IL-12 plasmid and the novel TRACETM-enabled DNA electroporation device.

About PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study)
PISCES is a planned, global, multicenter phase 2b, open-label trial of intratumoral pIL-12 (tavokinogene telseplasmid or “tavo”) plus electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of ImmunoPulse IL-12 in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR) in anti-PD-1 non-responder patients.

For more information please visit our website at www.oncosec.com.

On September 27, 2017 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive, blood-based liquid biopsy tests to assist in the early detection of cancer, reported that its CLIA laboratory has successfully completed a rigorous validation study of DetermaVu, OncoCyte’s diagnostic test for lung cancer (Press release, BioTime, SEP 27, 2017, View Source [SID1234520663]). In this study, OncoCyte assayed approximately 120 samples previously tested in its 299-patient study presented at the American Thoracic Society conference in May 2017, with the goal of demonstrating that OncoCyte’s new clinical laboratory provides the same results on clinical samples as those obtained in its R&D lab. The results met all performance criteria, demonstrating the accuracy and robustness of the assay as performed in the Company’s CLIA laboratory. The CLIA lab validation study included specific protocols to confirm the accuracy, reproducibility, and precision/repeatability of DetermaVu.

“The laboratory staff and procedures in place in the clinical laboratory have been confirmed to provide accurate, reliable, consistent and reproducible results,” said William Seltzer, PhD, FACMG, VP of Clinical Services and the Laboratory Director for OncoCyte. “The results were consistent with the positive data reported at the American Thoracic Society 2017 International Conference, and have enabled us to initiate our Clinical Validation Study, the final step prior to the commercial launch of DetermaVu.”

The Clinical Validation Study has now begun and is expected to be completed in the fourth quarter of 2017. In this study, approximately 300 new blinded blood samples, which have been prospectively collected will be assayed in the CLIA lab using DetermaVu. The performance of the test will be assessed against the clinical diagnosis of the patients from whom the samples were collected. If the Clinical Validation Study is successful and the results meet commercial requirements, OncoCyte will commence the commercial launch of DetermaVu.

“Successful completion of the CLIA Lab Validation Study is another important step toward launching DetermaVu,” said William Annett, President and Chief Executive Officer. “We plan to complete the ongoing Clinical Validation Study in the fourth quarter.”

OncoCyte believes that widespread utilization of DetermaVu could result in a substantial reduction in the number of unnecessary, expensive lung biopsies performed annually in the U.S., with a corresponding reduction in the surgical risk to patients undergoing biopsy procedures. Broad use of DetermaVu would result in a fundamental advancement in the diagnosis of suspicious lung nodules by allowing physicians to determine more accurately which patients need biopsies and which patients only need follow-up imaging. The Company estimates that approximately 1.4 million patients annually in the U.S. could benefit from the DetermaVu test. Depending on market penetration and reimbursable pricing, this could translate into a market opportunity of up to $4.7 billion annually.

On September 27, 2017 DelMar Pharmaceuticals (Nasdaq: DMPI) (“DelMar” and “the Company”), a biopharmaceutical company focused on the development of new cancer therapies, reported that it will be presenting an abstract at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference: Addressing Critical Questions in Ovarian Cancer Research and Treatment, being held on October 1-4, 2017 in Pittsburgh, PA at the Wyndham Grand (Press release, DelMar Pharmaceuticals, SEP 27, 2017, View Source [SID1234520661]).

DelMar researchers will present a poster entitled, “Distinct mechanism of action of DNA damaging agent dianhydrogalactitol (VAL-083) suggests combination therapy with PARP inhibitors” on Monday, October 2nd from 6:00PM – 8:30PM EDT. DelMar’s presentation will focus on the mechanism of action (MOA) of DNA damaging agent dianhydrogalactitol (VAL-083) and activity as a single-agent against treatment resistant tumors and opportunities for combination therapy with PARP inhibitors and other common ovarian cancer treatments.

On September 18th, 2017, DelMar announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug Application (IND) for an open label multi-center Phase 1/2 Study of VAL-083 in Patients with Recurrent Platinum Resistant Ovarian Cancer (VAL-083 REPROVe Trial). The VAL-083 REPROVe Trial is designed to evaluate the safety and efficacy of VAL-083 in patients with recurrent adenocarcinoma of the ovary, whose cancer has been previously treated with a minimum of two courses of platinum-based chemotherapy, and whose cancer has recurred within six months of the most recent platinum-based chemotherapy. Further details can be found on clinicaltrials.gov: View Source

Ovarian cancer remains the leading cause of death among women with gynecological cancers and the fifth most frequent cause of cancer deaths in women overall. In 2016, approximately 22,300 women in the US were diagnosed with ovarian cancer and 14,300 died from their disease. The vast majority of these deaths were patients whose tumors had become resistant to platinum-based chemotherapy regimens. Currently, there are no high-efficacy therapeutic options for platinum-resistant ovarian cancer, leaving these cancer patients with very poor prognosis. According to published literature, the overall response rate (ORR) to second line therapy is in the 10-15% range and overall survival is approximately 12-months.

About VAL-083

VAL-083 (dianhydrogalactitol) is a “first-in-class”, DNA-targeting agent that introduces interstrand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes (NCI).

VAL-083 has been granted an orphan drug designation by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas. VAL-083 is currently being studied in multiple clinical trials as a potential new treatment for glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.

DelMar has demonstrated that VAL-083’s mechanism of action is distinct from multiple chemotherapies widely used in the treatment of cancer and that this unique mechanism may offer opportunities to overcome treatment resistance thereby offering new treatment options to cancer patients. Further details regarding these studies can be found at View Source

On September 27, 2017 Cellectar Biosciences, Inc. (Nasdaq: CLRB), an oncology-focused, clinical stage biotechnology company (the “company”), reported that a patient treated with the company’s lead PDC compound, CLR 131 in the fourth cohort of its Phase I dose escalation safety trial in relapse or refractory multiple myeloma achieved a partial response (PR) (Press release, Cellectar Biosciences, SEP 27, 2017, View Source [SID1234520659]).

The primary objective of the study is to determine the highest dose patients can tolerate. The trial’s Data Monitoring Committee (DMC) determined that the fourth cohort dose of 31.25 mCi/m2 was safe and tolerated. Additionally, the company is monitoring signals of efficacy, including surrogate markers M protein and free light chain (FLC). The International Myeloma Working Group (IMWG) defines a PR as a greater than or equal to 50 percent decrease in FLC levels (for patients in whom M protein is unmeasurable) or 50 percent decrease in M protein.

Cohort 4 had three evaluable patients enrolled, each with heavily pretreated relapsed or refractory multiple myeloma (greater than five prior lines) and high degree of tumor burden upon entry into the trial. Each patient in the cohort received a single 31.25 mCi/m2 dose of CLR 131 as a 30-minute infusion, and was evaluated over the course of 85 days for safety and efficacy. All three patients in the cohort experienced clinical benefit with two patients achieving stable disease and one patient achieving a PR. One patient experiencing stable disease attained a 44 percent reduction in M protein. The patient experiencing a partial response had an 82 percent reduction in FLC. This patient did not produce M protein, received seven prior lines of treatment including radiation, stem cell transplantation and multiple combination treatments including one with daratumumab that was not tolerated.

“The encouraging data from Cohort 4 including the partial response and the DMC’s determination that the 31.25 mCi/m2 of CLR 131 was safe is impressive in light of the highly advanced disease and heavily pretreated patients within the cohort,” said Jim Caruso, president and CEO of Cellectar Biosciences. “Given the preclinical and clinical data results we’ve seen to date, the company intends to advance the compound into a fifth cohort using a multi-dose regimen.”

On April 27, 2017, the company reported that preclinical experiments providing multiple doses (two or three doses) of CLR 131 resulted in a statistically significant benefit in survival and tumor burden reduction compared to a single dose regimen. Therefore the company has now elected to advance with a multi-dose regimen, which may provide patients with enhanced clinical benefits and treatment outcomes.

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated as a single-dose treatment in a Phase 1 clinical trial in patients with relapsed or refractory (R/R) multiple myeloma (MM) as well as in a Phase 2 clinical trial for R/R MM and select R/R lymphomas with either a one- or two-dose treatment. CLR 131 represents a novel approach to treating hematological diseases and based upon preclinical and interim Phase 1 study data may provide patients with therapeutic benefits including, overall survival, an improvement in progression-free survival, and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131, directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate the discovery and development of improved targeted novel therapeutic compounds. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in more than 80 different xenograft models of cancer.

On September 27, 2017 Pfizer Inc. (NYSE: PFE) reported that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved BAVENCIO (avelumab, genetically recombinant Injection 200mg/mL for intravenous use) as the first and only treatment indicated for curatively unresectable Merkel cell carcinoma (MCC), a rare and aggressive cancer, in Japan (Press release, Pfizer, SEP 27, 2017, View Source [SID1234520658]).

“Today marks the approval of the first-ever treatment indicated for Merkel cell carcinoma in Japan, making this a significant milestone for patients living with this devastating type of skin cancer,” said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany, which operates as EMD Serono in the US and Canada. “This decision by the MHLW also signifies the first approval of an anti-PD-L1 in Japan.”

“This is the fifth approval for BAVENCIO in 2017 and the first in an Asian market,” said Andreas Penk, M.D., Regional President Oncology International Developed Markets, Pfizer Oncology. “Today’s announcement demonstrates our continued determination to provide access to our immunotherapy for people around the world living with hard-to-treat cancers such as Merkel cell carcinoma.”

MCC is a designated rare disease in Japan and is estimated to affect fewer than 100 patients.[2],[3] BAVENCIO previously received Orphan Drug Designation from the MHLW in December 2016.

“Until now, there were no licensed treatments for MCC in Japan,” said Dr Naoya Yamazaki, Chief of the Department of Dermatologic Oncology, National Cancer Center Hospital, Japan. “As a cancer that progresses quickly and has, for so many, a poor prognosis, today’s approval is a huge step forward for people impacted by this destructive disease.”

This approval is based on data from JAVELIN Merkel 200, an international, multicenter, single-arm, open-label, Phase II study in patients with metastatic MCC.[1]

The JAVELIN Merkel 200 study is the largest registrational clinical trial for an immunotherapy in metastatic MCC. The results of this study were previously presented at the June 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual congress and published in the October 2016 edition of Lancet Oncology.

The MHLW’s decision follows BAVENCIO’s recent approval by the European Commission on September 18, 2017, as a monotherapy for the treatment of adult patients with metastatic MCC (mMCC). BAVENCIO was also granted marketing authorization by Swissmedic on September 05, 2017, for the treatment of patients with mMCC, whose disease has progressed after at least one chemotherapy treatment. Earlier this year, the US Food and Drug Administration (FDA) granted accelerated approval* for BAVENCIO for the treatment of mMCC and patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy.

The clinical development program for BAVENCIO, known as JAVELIN, involves at least 30 clinical programs and more than 6,300 patients evaluated across more than 15 different tumor types. In addition to mMCC, these cancers include breast, gastric/gastro-esophageal junction, head and neck, Hodgkin’s lymphoma, melanoma, mesothelioma, non-small cell lung, ovarian, renal cell carcinoma and urothelial carcinoma.

About Merkel Cell Carcinoma

MCC is a rare and aggressive disease in which cancer cells form in the top layer of the skin, close to nerve endings.[4],[5] MCC, which is also known as neuroendocrine carcinoma of the skin or trabecular cancer, often starts in those areas of the skin that are most often exposed to the sun, including the head and neck, and arms.[4],[6] Risk factors for MCC include sun exposure and infection with Merkel cell polyomavirus. Caucasian males older than 50 are at increased risk.[4],[6] MCC is often misdiagnosed as other skin cancers and grows at an exponential rate on chronically sun-damaged skin.[6-8] Current treatment options for MCC include surgery, radiation and chemotherapy.[5] Treatment for metastatic or Stage IV MCC is generally palliative.[5]

About JAVELIN Merkel 200

The efficacy and safety of BAVENCIO was demonstrated in the JAVELIN Merkel 200 trial, a Phase II, open-label, single-arm, multicenter study, in metastatic MCC.[1] The trial excluded patients with active or a history of central nervous system (CNS) metastasis, prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, active or a history of autoimmune disease, a history of other malignancies within the last 5 years, organ transplant, and conditions requiring therapeutic immune suppression or active infection with HIV, or hepatitis B or C. Patients received BAVENCIO 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

The JAVELIN Merkel 200 study is the largest registrational clinical trial for an immunotherapy in metastatic MCC. The results of this study were previously presented at the June 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual congress and published in the October 2016 edition of Lancet Oncology.

About BAVENCIO

BAVENCIO (avelumab) is a human antibody specific for a protein called PD-L1, or programmed death ligand-1. 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. BAVENCIO has been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

*Indications in the US[9]

The US Food and Drug Administration (FDA) granted accelerated approval for BAVENCIO for the treatment of (i) mMCC in adults and pediatric patients 12 years and older and (ii) 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. These indications were approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Safety Information from the US FDA Approved Label

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 antihyperglycemics or insulin in patients with severe or life-threatening (Grade 3 equal to or greater) 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 one 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 one 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, greater than or equal to 20%) in patients with metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reactions (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%).

Selected treatment-emergent laboratory abnormalities (all grades, greater than or equal to 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 greater than or equal to 20%) in patients with locally advanced or metastatic urothelial carcinoma (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, greater than or equal to 3%) inpatients with locally advanced or metastatic UC were hyponatremia (16%), increased gamma-glutamyltransferase (12%), lymphopenia (11%), hyperglycemia (9%), increased alkaline phosphatatse (7%), anemia (6%), increased lipase (6%), hyperkalemia (3%), and increased aspartate aminotransferase (3%).

Please see full US Prescribing Information and Medication Guide available at www.BAVENCIO.com.