On May 19, 2021 Targovax ASA’s ("Targovax" or the "Company") stock exchange reported that Published on 18 May 2021, regarding the board of directors’ resolution to increase the Company’s share capital with NOK 2,129.90 by the issuance of 21,299 new shares, each with a nominal value of NOK 0.10, in order to facilitate an exercise of 21,299 RSUs pursuant to the Company’s RSU program for Board members (Press release, Targovax, MAY 19, 2021, View Source [SID1234580281]).

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Primary insider, Bente-Lill Romøren, member of the board of directors, has exercised

15,250 restrictive stock units ("RSUs") under her RSU agreement and subscribed for 15,250 new shares in the Company following the exercise of RSUs. The exercise price for the options was NOK 0.10 per new share.

Following the RSU exercise and subscription of new shares and the registration of the share capital increase pertaining to the new shares with the Norwegian Register of Business Enterprises (Nw. Foretaksregisteret), Bente-Lilll Romøren holds 35,577 shares, 11,361 RSUs and nil options in Targovax.

On May 19, 2021 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported preliminary safety and anti-tumor activity data from the Company’s ongoing Phase 1 clinical trial of MGC018 (Press release, MacroGenics, MAY 19, 2021, View Source [SID1234580280]). This investigational antibody-drug conjugate (ADC) was designed to deliver a DNA alkylating duocarmycin payload to both dividing and non-dividing cells in a B7-H3-dependent manner. The dataset will be presented in a poster titled "Phase 1 Dose Escalation Study of MGC018, an anti-B7-H3 Antibody-Drug Conjugate (ADC), In Patients with Advanced Solid Tumors" (Abstract #2631) at the upcoming 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held June 4-8, 2021.

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Dose Escalation Results Update

The ASCO (Free ASCO Whitepaper) abstract included data as of January 21, 2021; updated data as of a May 3, 2021 cut-off are included below and will be presented at ASCO (Free ASCO Whitepaper).

A total of 29 patients with advanced solid tumors were enrolled in five dose escalation cohorts with MGC018 at 0.5 to 4.0 mg/kg, administered intravenously every three weeks. This included six patients at the 4.0 mg/kg cohort enrolled subsequent to the 2020 ASCO (Free ASCO Whitepaper) poster presentation. A recommended Phase 2 dose (RP2D) was defined as 3.0 mg/kg every three weeks.

mCRPC. Preliminary evidence of anti-tumor activity by MGC018 has been observed, most notably in patients with advanced metastatic castration-resistant prostate cancer (mCRPC). Reductions in prostate-specific antigen (PSA) levels of ≥ 50% were observed in five of nine mCRPC patients treated in dose escalation, including one with substantial regression of bone disease. Of the nine patients with mCRPC, eight were evaluated for tumor response, all of whom demonstrated a best response of stable disease. Two of these eight patients had measurable disease; both had reductions in target lesions, including a 29% reduction in one patient. The nine mCRPC patients treated in dose escalation received a median of four therapies prior to MGC018, including taxane chemotherapy (eight patients) and next generation hormonal agents (all patients had previously received abiraterone, enzalutamide or both). All nine mCRPC patients in dose escalation are off therapy. Of the five patients who had ≥ 50% PSA reduction, one withdrew consent (without disease progression) at 4 months, one had new bone lesions at 6 months, one initiated subsequent therapy at 6 months, and two had no progression at 7 months.

Melanoma. During dose escalation, three melanoma patients were administered MGC018 at 4.0 mg/kg (the highest dose administered). All had previously received three different checkpoint inhibitor agents. The best responses in target lesion sum reductions for these patients after being treated with MGC018 were 24%, 28% and 36% (confirmed partial response), with this last patient remaining on MGC018 therapy for more than 6 months as of the data cut-off. Based on these data, MacroGenics recently initiated a melanoma expansion cohort (N=approximately 20).

Safety. Adverse events for the dose escalation cohorts of 0.5 mg/kg to 4.0 mg/kg as of the May 3, 2021 data cut-off were generally consistent with those previously reported at ASCO (Free ASCO Whitepaper) 2020. MGC018-related toxicities included hematologic and skin toxicities that have been clinically manageable. In dose escalation overall, at least one treatment-related adverse event was experienced by 27 of 29 patients (93%). At 4.0 mg/kg, one patient developed a dose-limiting toxicity manifested by Grade 3 fatigue that lasted for more than 72 hours and as previously reported, a Grade 4 neutropenia occurred in a patient in the 2.0 mg/kg cohort.

Preliminary Results for mCRPC Cohort Expansion

As of the May 3, 2021 data cut-off, 28 of the 40 patients in the mCRPC cohort expansion had been enrolled, with disease classification available for 20 of these patients: seven had bone only, nine had mixed soft tissue and bone, and four had soft tissue only. Of the 28 mCRPC patients in cohort expansion, 22 had received at least one dose of MGC018 and had a post-baseline PSA. Eleven of these 22 patients (50%) had a PSA reduction of 50% or greater. All but three of these 22 patients were still on therapy as of the data cut-off. Of 13 patients who had measurable disease, six were not yet evaluable and seven had their first 9-week imaging, of which four had reductions in target lesion sums of 13%, 21%, 27% and 35% (unconfirmed partial response). Twelve of these 13 patients were still ongoing on MGC018.

"We continue to be very encouraged by evolving data from our ongoing Phase 1 study of MGC018. To date, we have observed preliminary signals of anti-tumor effects, including PSA reductions of 50% or more in 16 of 31 (52%) patients with late-stage castration-resistant prostate cancer across dose escalation and dose expansion," said Scott Koenig, M.D., Ph.D., President and CEO. "We are very pleased to report decreases in target lesion sums, including an unconfirmed partial response, in mCRPC patients with measurable disease. Finally, we are encouraged to see anti-tumor activity, including a confirmed partial response, in post-checkpoint melanoma patients who have received MGC018. We look forward to sharing the full data at ASCO (Free ASCO Whitepaper) and providing further updates on our ongoing dose expansion cohorts, including patients with mCRPC, non-small cell lung cancer, triple negative breast cancer, melanoma and squamous cell carcinoma of the head and neck, at subsequent scientific conferences."

Conference Call

MacroGenics’ management will host a conference call and webcast with external guest presenters to discuss the preliminary MGC018 results on Friday, June 4, 2021 at 4:30 P.M. ET. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) ten minutes prior to the start of the call and provide the Conference ID: 1583522. The listen-only audio and slide webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days.

ASCO Presentation

The abstract for MacroGenics’ MGC018 poster presentation was submitted to ASCO (Free ASCO Whitepaper) in February 2021 and is available on the ASCO (Free ASCO Whitepaper) website at View Source The poster will be available for on-demand viewing on the ASCO (Free ASCO Whitepaper) website and on the Events & Presentations page on MacroGenics’ website at View Source on or around June 4, 2021.

About MGC018

MGC018 is an ADC comprised of an anti-B7-H3 humanized IgG1/kappa monoclonal antibody conjugated via a cleavable linker to the prodrug seco-DUocarmycin hydroxyBenzamide Azaindole (DUBA; licensed from Byondis, B.V.), with an average drug-to-antibody ratio (DAR) of ~2.7. DUBA is an alkylating agent that can damage DNA in both dividing and non-dividing cells, causing cell death. B7-H3 is a molecule highly expressed on many solid tumors and associated with a poor clinical outcome. MGC018 is being evaluated in a Phase 1 study (NCT03729596). MacroGenics retains worldwide rights to MGC018.

On May 19, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported additional clinical data for lifileucel alone and in combination with pembrolizumab in patients with advanced melanoma (Press release, Iovance Biotherapeutics, MAY 19, 2021, View Source [SID1234580279]). The data are available in two ASCO (Free ASCO Whitepaper) abstracts, with additional updates to be provided at the upcoming ASCO (Free ASCO Whitepaper) 2021 Annual Meeting, to be held June 4-8, 2021 .

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Maria Fardis, Ph.D., President and Chief Executive Officer of Iovance Biotherapeutics, stated, "We are very excited that our latest clinical datasets demonstrate the broad potential for lifileucel in advanced melanoma. For the first time we are reporting results for lifileucel as an earlier treatment for advanced melanoma in combination with pembrolizumab, demonstrating an overall response rate (ORR) of 86% in patients who are naïve to anti-PD-1 therapy. We are impressed with the results for this combination regimen, particularly since pembrolizumab alone demonstrated a 33% ORR in a comparable patient population. In addition, in a post-PD1 advanced melanoma patient population in Cohort 2 in the C-144-01 study, shorter duration of prior anti-PD-1 therapy maximizes Duration of Response (DOR) to lifileucel treatment."

Lifileucel in Combination with Pembrolizumab in Advanced Melanoma (IOV-COM-202 Study)
Early data suggest the response rate of lifileucel plus pembrolizumab may be additive in patients with immune checkpoint inhibitor (ICI)-naïve advanced melanoma. Cohort 1A in the IOV-COM-202 study is evaluating lifileucel in combination with pembrolizumab in up to 12 patients who are naïve to ICI, or anti-PD-1, therapy. Six of the initial seven patients had a confirmed objective response, representing an 86% ORR (1 Complete Response (CR) and 5 Partial Responses (PR), with one best response of stable disease (abstract data extraction: February 2021). The longest duration of response was 16.8 months.

The Treatment-Emergent Adverse Event (TEAE) profile was consistent with the underlying disease and known Adverse Event (AE) profiles of pembrolizumab, NMA-LD and IL-2. These encouraging data confirm the potential feasibility and activity of lifileucel in combination with pembrolizumab in early-line treatment of patients with advanced melanoma. Updated results for the initial seven patients will be available in the upcoming ASCO (Free ASCO Whitepaper) poster.

Lifileucel Following anti-PD-1 therapy in Advanced Melanoma (C-144-01 clinical study)
As previously reported, the long-term follow-up data for Cohort 2 in the C-144-01 clinical study continue to demonstrate durability and depth of lifileucel TIL therapy response. DOR was not reached at 28.1 months of median study follow up and ORR remained at 36.4 percent.

New data in the ASCO (Free ASCO Whitepaper) abstract suggest that DOR was positively associated with shorter cumulative duration of prior anti-PD-1 therapy. In responders, the median cumulative duration and median prior lines of anti-PD-1 therapy was 4.4 months (range: 1.4-22.5 months) and 1.5 lines (range: 1-4). These results support earlier use of lifileucel following anti-PD-1 therapy instead of retreatment with anti-PD-1 based – regimens.

All patients in Cohort 2 had high baseline disease burden and were heavily pretreated (3.3 mean prior therapies), including anti-PD1 and BRAF/MEK inhibitors if BRAFV600 mutation positive. The adverse event profile was consistent with the underlying advanced disease, lymphodepletion and IL-2 regimens, with no new adverse events emerging over time. Updated results for Cohort 2 with longer duration of follow up will be part of the oral presentation during ASCO (Free ASCO Whitepaper) 2021.

Iovance Presentation and Poster at ASCO (Free ASCO Whitepaper) 2021

Title: Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma: Evaluation of impact of prior anti-PD-1 therapy.
Authors: James M. G. Larkin, et al.
Session Title: Melanoma/Skin Cancers
Session Type: Oral Abstract Session
Abstract Number: 9505
Location: ASCO (Free ASCO Whitepaper) Meeting Library at View Source and View Source
Session Date and Time: Sunday, June 6, 2021 from 8:00 – 11:00 a.m. ET

Title: Safety and efficacy of lifileucel (LN-144), an autologous, tumor infiltrating lymphocyte cell therapy in combination with pembrolizumab for immune checkpoint inhibitor naïve patients with advanced melanoma.
Authors: Sajeve Samuel Thomas, et al.
Session Title: Melanoma/Skin Cancers
Session Type: ePoster Session
Abstract Number: 9537
Location: ASCO (Free ASCO Whitepaper) Meeting Library at View Source and View Source
ePoster Viewing: on demand beginning Friday, June 4, 2021 at 9:00 a.m. ET

On May 19, 2021 Sensei Biotherapeutics, a clinical-stage immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, reported new data from the ongoing Phase 1/2 clinical trial of SNS-301, an investigational medicine in patients with advanced squamous cell carcinoma of the head and neck (SCCHN), in combination with pembrolizumab (Press release, Sensei Biotherapeutics, MAY 19, 2021, View Source [SID1234580278]). The data will be presented as a poster by Alain Algazi, M.D., from the University of California San Francisco to the medical community at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place virtually June 4 – 8, 2021.

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As of the April 14, 2021 cut-off date, 21 patients with locally advanced unresectable or metastatic SCCHN had been enrolled and treated in the study. Twenty of the patients enrolled did not achieve an objective response to prior treatment with PD-1 blockade (Cohort A) and one patient was PD-1 blockade naïve (Cohort B). The safety profile of SNS-301 in combination with pembrolizumab observed from 20 evaluable patients was favorable and consistent with previously reported data. Efficacy data was available from twelve patients in Cohort A. Notably, the efficacy bar was set high by enrolling patients with no objective response to prior PD-1 blockade (median 7.5 months). Data from nine evaluable patients from Cohort A were last reported from this study at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Annual Meeting.

"These data suggest SNS-301, when combined with PD-1 blockade, has the potential to provide long-term benefit as second and later line treatment for patients with late-stage cancer and few other treatment options," said Marie-Louise Fjallskog, M.D., Ph.D., Chief Medical Officer of Sensei Biotherapeutics. "We expect to report more mature data, including data for SNS-301 combination therapy in the frontline setting, by the end of this year."

"This study continues to enhance our understanding of the broad potential of our ImmunoPhage platform," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "The information we are gathering is just one aspect of the potential of our ImmunoPhage platform to expand the durability and improve the treatment of many devastating cancers. Our team continues to lead advances in the understanding of bacteriophage through internal research and collaborations with world-class academic laboratories, and we are excited to apply these learnings to our pipeline of ImmunoPhage programs."

Data from Phase 1/2 Trial of SNS-301 SSCCHN As of April 14, 2021

Data highlighted today are part of a poster (#6029), titled: "Update on Safety and Efficacy of a Phase 1/2 Trial of SNS-301 and Pembrolizumab in Patients with Advanced Squamous Cell Carcinoma of the Head and Neck." The abstract and related poster can be downloaded from the ASCO (Free ASCO Whitepaper) Meeting Library.

Safety Data

As of the data cut-off, a safety analysis conducted in 20 evaluable patients showed that SNS-301 in combination with pembrolizumab continues to have a favorable safety profile.

The combination of SNS-301 and pembrolizumab was well tolerated. Mostly Grade 1-2, mild to moderate, unrelated adverse events (AE) were observed. Four Grade 3 AEs were reported as treatment-related: dehydration, pruritus, rash and EKG QT prolongation.
Efficacy Data

An analysis of anti-tumor activity was conducted in 12 patients who did not achieve an objective response to prior treatment with PD-1 blockade (Cohort A). No patients were evaluable from Cohort B as of the cut-off date.

67% (n=8/12) of patients achieved stable disease (SD) or partial response (PR), including:
One patient with PD-L1 negative tumor who achieved a tumor reduction of 71% that is still ongoing after 11 months of therapy. Nanostring data for this patient show T-cell increase and T-cell activation.
Seven patients achieved SD, including two patients with long-standing SD (8 and 10 months).
Patient outcomes appear to correlate to post-treatment PD-L1 expression and immune infiltration in tumors.

Analyses of secondary endpoints using ELISA and ELISPOT assays to evaluate SNS-301 specific B and T cell responses in patient samples are ongoing. Sensei expects to report these data as part of the larger dataset planned by the end of 2021. Sensei also plans to add a third cohort by the end of 2021 to evaluate SNS-301 with HPV-specific E6/E7 ImmunoPhage.

About the Phase 1/2 Clinical Study

The multi-center Phase 1/2 clinical trial is designed to evaluate safety, tolerability, and anti-tumor activity of SNS-301 in combination with pembrolizumab, as well as immune response and tumor/immune biomarkers. The study has two cohorts with a total of 60 patients with locally advanced unresectable or metastatic squamous cell carcinoma of the head and neck (SCCHN) who did not achieve a response to prior treatment with PD-1 blockade (Cohort A) or patients who did not receive prior therapy with PD-1 blockade (Cohort B).

About ImmunoPhage Platform

Sensei’s proprietary ImmunoPhage platform enables the delivery of innovative treatments that are personalized to a patient’s own tumor specific antigens. Bacteriophages have built-in capabilities that utilize the inherent nature of viruses to elicit the innate and adaptive immune system, supporting a highly immunogenic approach. SNS-301 is a first-in-class and self-adjuvanted bacteriophage-base immune-activating vaccine targeting human aspartate β-hydroxylase (ASPH), a tumor-associated antigen commonly overexpressed in cancer.

About SNS-301

SNS-301 is a first-in-class cancer immunotherapy designed to overcome immune tolerance and induce robust and durable antigen-specific humoral and cellular responses. It is a bio-engineered, inactivated bacteriophage virus expressing a fragment of the tumor-associated antigen, ASPH, as a fusion protein to the bacteriophage lambda capsid decoration protein, gpD. Expression of ASPH is uniquely upregulated in more than 20 different types of cancer and expression levels in various tumors are generally inversely correlated with disease prognosis. ASPH signaling is related to cancer cell growth, cell motility and invasiveness, occurs through the Notch pathway and is implicated in the epithelial to mesenchymal transition (EMT).

On May 19, 2021 MorphoSys AG (FSE:MOR; NASDAQ:MOR) reported that new data from the tafasitamab (Monjuvi(R)) development program will be presented at the upcoming 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 4-8, 2021 (Press release, MorphoSys, MAY 19, 2021, View Source [SID1234580277]).

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Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, which was approved as Monjuvi(R) (tafasitamab-cxix) in July 2020 by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

"We are proud to present important findings from our comprehensive development program for tafasitamab at the ASCO (Free ASCO Whitepaper) Annual Meeting, including three-year follow-up data from the Phase 2 L-MIND study showing a long durability of responses and overall survival in patients with R/R DLBCL," commented Dr. Malte Peters, Chief Research and Development Officer at MorphoSys. "In addition, we will show details from our First-MIND study in front-line DLBCL, indicating our ambition to position Monjuvi as a back-bone strategy in DLBCL and to increase cure rates or duration of remission in DLBCL across all lines of therapy."

Abstracts accepted for presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting include:

Poster Discussion

LONG-TERM ANALYSES FROM L-MIND, A PHASE 2 STUDY OF TAFASITAMAB (MOR208) COMBINED WITH LENALIDOMIDE (LEN) IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (R/R DLBCL)

Abstract Number: 7513
Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

ePosters

First-MIND: A PHASE 1B, OPEN-LABEL, RANDOMIZED STUDY TO ASSESS SAFETY OF TAFASITAMAB (TAFA) OR TAFA + LENALIDOMIDE (LEN) IN ADDITION TO R‑CHOP IN PATIENTS WITH NEWLY DIAGNOSED DLBCL

Abstract Number: 7540
Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

A PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TAFASITAMAB PLUS LENALIDOMIDE AND RITUXIMAB VERSUS PLACEBO PLUS LENALIDOMIDE AND RITUXIMAB IN PATIENTS WITH RELAPSED/REFRACTORY (R/R) FOLLICULAR LYMPHOMA (FL) OR MARGINAL ZONE LYMPHOMA (MZL)[1]

Abstract Number: TPS7568
Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

Please refer to the ASCO (Free ASCO Whitepaper) online program for full session details and data presentation listings: View Source All presentations will be available on demand starting June 4, 2021.

MorphoSys is looking forward to meeting registered ASCO (Free ASCO Whitepaper)21 Virtual attendees at its virtual booth accessible through the conference website and through the company’s ASCO (Free ASCO Whitepaper) microsite at www.morphosysevents.com.

About Tafasitamab
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi(R) is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi(R) is a registered trademark of MorphoSys AG.

XmAb(R) is a registered trademark of Xencor, Inc.

Important Safety Information

What are the possible side effects of MONJUVI?

MONJUVI may cause serious side effects, including:

– Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.

– Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4 F (38 C) or above, or any bruising or bleeding.

– Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4 F (38 C) or above, or develop any signs and symptoms of an infection.

The most common side effects of MONJUVI include:

– Feeling tired or weak

– Diarrhea

– Cough

– Fever

– Swelling of lower legs or hands

– Respiratory tract infection

– Decreased appetite

These are not all the possible side effects of MONJUVI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

– Have an active infection or have had one recently.

– Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.

– You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.

– Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.

– Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.

You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.