UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Item 7.01 - Regulation FD Disclosure.
As previously announced, ImmunoGen, Inc. (the “Company”) will host an investor conference call on December 7, 2020 at 8:00 a.m., ET, to discuss recent updates for IMGN632 in blastic plasmacytoid dendritic cell neoplasm (“BPDCN”) and acute myeloid leukemia. A copy of the investor presentation to be used on the investor conference call is being furnished with this Current Report on Form 8-K as Exhibit 99.2.
Item 8.01 - Other Events.
On December 5, 2020, the Company issued a press release relating to safety and efficacy findings from the expansion phase of the Company’s Phase 1/2 clinical trial of IMGN632 in patients with relapsed/refractory BPDCN that were presented during an oral session at the 62nd American Society of Hematology (ASH) Annual Meeting on December 5, 2020. A copy of the press release is being filed with this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.
In addition, the U.S. Food and Drug Administration (FDA) advised the Company to add a pivotal cohort of up to 20 newly-diagnosed patients to the Company’s ongoing Phase 1/2 clinical trial of IMGN632 in relapsed/refractory BPDCN to support a potential label that could cover all BPDCN patients, both frontline and relapsed or refractory. With the benefit of this guidance from FDA, the Company has moved forward with this pivotal cohort and expects to complete enrollment and generate topline data from the study within the next 12 to 18 months, with a biologics license application (BLA) submission expected in 2022.
Forward-Looking Statements
This Current Report on Form 8-K includes forward-looking statements based on management's current expectations. These statements include, but are not limited to, the Company’s expectations related to: the occurrence, timing, and outcome of potential pre-clinical, clinical, and regulatory events related to the Company’s product candidates, in particular with respect to IMGN632; and the presentation of pre-clinical and clinical data on the Company’s product candidates, in particular with respect to IMGN632. For these statements, the Company claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. Various factors could cause the Company’s actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this Current Report on Form 8-K. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the timing and outcome of the Company’s pre-clinical and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical studies, clinical trials, and regulatory processes; the Company’s ability to financially support its product programs; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting impact on the Company’s industry and business; and other factors more fully described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 and other reports filed with the Securities and Exchange Commission.
Item 9.01 – Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. | Description |
99.1 | |
99.2 | Investor presentation to be presented by ImmunoGen, Inc. on December 7, 2020. |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL (eXtensible Business Reporting Language) document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ImmunoGen, Inc. | |
(Registrant) | |
Date: December 7, 2020 | /s/ David G. Foster |
David G. Foster | |
Vice President, Finance | |
Exhibit 99.1
ImmunoGen Presents Updated Findings from Phase 1/2 Study of IMGN632 in Blastic Plasmacytoid Dendritic Cell Neoplasm at ASH Annual Meeting
Updated Data Demonstrating Favorable Safety Profile and Encouraging Monotherapy Activity in BPDCN Presented During Oral Session
Preclinical Combination Data in Relapsed/Refractory AML Support Further Evaluation of Triplet; Trial in Progress Poster for Phase 1b/2 Study Presented
Conference Call to be Held on Monday, December 7 at 8:00 a.m. ET
Waltham, MA – December 5, 2020 – ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that new safety and efficacy findings from the expansion phase of the Phase 1/2 study of IMGN632 in patients with relapsed/refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN) were presented during an oral session at the 62nd American Society of Hematology (ASH) Annual Meeting.
“Comprising the largest prospective study with a single agent in patients with relapsed/refractory BPDCN, the results presented at ASH build on the previous data reported for IMGN632 and reinforce the potential of this CD123-targeting ADC as a best-in-class treatment option for BPDCN,” said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. “Given IMGN632’s favorable safety profile, demonstrated anti-tumor activity, and ease of administration via short infusion in an outpatient setting, we continue to enroll both frontline and relapsed/refractory BPDCN patients in this trial. In addition, the preclinical data presented by our partners at MD Anderson Cancer Center in relapsed/refractory AML further support the combination of IMGN632 with azacitidine and venetoclax, which we are actively enrolling in a Phase 1b/2 clinical trial.”
“BPDCN is a rare, aggressive hematologic malignancy that is characterized by historically low overall survival rates,” said Naveen Pemmaraju, MD, Associate Professor in the Department of Leukemia at MD Anderson Cancer Center. “Despite currently available therapies, outcomes for relapsed/refractory patients remain poor and there is an urgent need to develop better-tolerated treatment options in the frontline setting. These updated safety and efficacy findings for IMGN632 in patients with relapsed/refractory BPDCN are encouraging, and I look forward to advancing IMGN632 into pivotal development.”
IMGN632 MONOTHERAPY DATA IN BPDCN
Title: “Clinical Profile of IMGN632, a Novel CD123-Targeting Antibody-Drug Conjugate, in Patients with Relapsed/Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm” (Abstract #167)
Oral Presentation Session: 616
Date: Saturday, December 5, 2020
Time: 12:30pm PT/3:30pm ET
Updated key findings include:
Safety
| ● | IMGN632 demonstrated a favorable safety profile in 29 patients who received 0.045 mg/kg once every 3 weeks via a short (under 30 minutes) intravenous infusion, with limited grade ≥3 treatment-related adverse events (AEs) and no treatment-related deaths. |
| ● | The most common grade ≥3 AEs were febrile neutropenia, hyperglycemia, and thrombocytopenia (10% each). |
| ● | Grade ≥3 liver function test elevations were seen in one patient (3%). |
| ● | No capillary leak syndrome was reported. |
Efficacy
| ● | In all relapsed/refractory BPDCN patients, the overall response rate (ORR) was 29% (8/28) with a composite complete remission (CCR) rate of 18% (5/28). |
| ● | In patients with prior SL-401 exposure (tagraxofusp-erzs), the ORR was 31% (4/13) with a CCR of 15% (2/13). |
| ● | Among patients with bone marrow response assessment, 60% (9/15) achieved a bone marrow complete response (blasts <5%). |
| ● | Durable responses were seen in multiple patients, up to 9.2 months without hematopoietic stem cell transplant. |
| ● | Two patients have been successfully bridged to hematopoietic stem cell transplant. |
TRIAL IN PROGRESS POSTER
Title: “A Phase 1b/2 Study of IMGN632, a CD123-Targeting Antibody-Drug Conjugate, As Monotherapy or in Combination with Venetoclax and/or Azacitidine for Patients with CD123-Positive Acute Myeloid Leukemia” (Abstract 1047)
Poster Session: 616
Date: Saturday, December 5, 2020
Time: 7:00am – 3:30pm PT/10:00am – 6:30pm ET
PRECLINICAL POSTER
In addition, our partners at MD Anderson Cancer Center will present preclinical data from their study combining IMGN632, venetoclax, and azacitidine in in vitro and in vivo AML models.
Title: “Combining IMGN632, a Novel CD123-Targeting Antibody Drug Conjugate with Azacitidine and Venetoclax Facilitates Apoptosis in Vitro and Prolongs Survival In Vivo in AML Models” (Abstract 2886)
Poster Session: 617
Date: Monday, December 7, 2020
Time: 7:00am – 3:30pm PT/10:00am – 6:30pm ET
Additional information can be found at www.hematology.org, including abstracts.
CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call on Monday, December 7 at 8:00 a.m. ET to discuss the data presented at ASH, the pathway to FDA approval in BPDCN, and an AML program progress update; Dr. Naveen Pemmaraju, Associate Professor in the Department of Leukemia at MD Anderson Cancer Center, will join the call to review the BPDCN data presented at ASH. To access the live call by phone, dial (877) 621-5803; the conference ID is 1795760. The call, along with associated slides, may also be accessed through the Investors and Media section of immunogen.com. Following the call, a replay will be available at the same location.
ABOUT IMGN632
IMGN632 is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and acute lymphocytic leukemia (ALL). IMGN632 is currently being evaluated in multiple cohorts, including monotherapy for patients with BPDCN and minimal residual disease positive (MRD+) AML following frontline induction therapy and in combinations with Vidaza® (azacitidine) and Venclexta® (venetoclax) for patients with relapsed/refractory AML. IMGN632 uses one of ImmunoGen's novel indolinobenzodiazepine (IGN) payloads, which alkylate DNA without crosslinking. IGNs have been designed to have high potency against tumor cells, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads. FDA has granted IMGN632 Breakthrough Therapy Designation in relapsed/refractory BPDCN.
ABOUT BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM (BPDCN)
BPDCN is a rare form of blood cancer that has features of both leukemia and lymphoma, with characteristic skin lesions, lymph node involvement, and frequent spread to the bone marrow. This aggressive cancer requires intense treatment often followed by stem cell transplant. Despite the approval of a CD123-targeting therapy, the unmet need remains high for patients, both in the frontline and in the relapsed/refractory setting.
ABOUT ACUTE MYELOID LEUKEMIA (AML)
AML is a cancer of the bone marrow cells that produce white blood cells. It causes the marrow to increasingly generate abnormal, immature white blood cells (blasts) that do not mature into effective infection-fighting cells. The blasts quickly fill the bone marrow, impacting the production of normal platelets and red blood cells. The resulting deficiencies in normal blood cells leave the patient vulnerable to infections, bleeding problems, and anemia. It is estimated that, in the U.S. alone, 21,380 patients will be diagnosed with AML this year and 10,590 patients will die from the disease.
ABOUT CD123
CD123, the interleukin-3 alpha chain, is expressed on multiple myeloid and lymphoid cancers including AML, BPDCN, ALL, chronic myeloid leukemia, and myeloproliferative neoplasms. With limited expression on normal hematopoietic cells, rapid internalization, and expression on AML leukemia stem cells, CD123 is a validated therapeutic target, with the approval of a CD123-targeting therapy for BPDCN.
ABOUT IMMUNOGEN
ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to “target a better now.”
Learn more about who we are, what we do, and how we do it at www.immunogen.com.
Vidaza® and Venclexta® are registered trademarks of their respective owners.
This press release includes forward-looking statements based on management's current expectations. These statements include, but are not limited to, ImmunoGen’s expectations related to: the occurrence, timing, and outcome of potential pre-clinical, clinical, and regulatory events related to ImmunoGen’s product candidates; and the presentation of pre-clinical and clinical data on ImmunoGen’s product candidates. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. Various factors could cause ImmunoGen’s actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this release. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the timing and outcome of ImmunoGen’s pre-clinical and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical studies, clinical trials, and regulatory processes; ImmunoGen’s ability to financially support its product programs; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting impact on ImmunoGen’s industry and business; and other factors more fully described in ImmunoGen’s Annual Report on Form 10-K for the year ended December 31, 2019 and other reports filed with the Securities and Exchange Commission.
INVESTOR RELATIONS AND MEDIA
ImmunoGen
Courtney O’Konek
781-895-0600
courtney.okonek@immunogen.com
OR
FTI Consulting
Robert Stanislaro
212-850-5657
robert.stanislaro@fticonsulting.com
Exhibit 99.2
| CONFIDENTIAL 1 IMGN632 Investor Call December 7, 2020 Exhibit 99.2 |
| CONFIDENTIAL 2 FORWARD LOOKING STATEMENTS This presentation includes forward-looking statements based on management's current expectations. These statements include, but are not limited to, ImmunoGen’s expectations related to: the occurrence, timing, and outcome of potential pre-clinical, clinical, and regulatory events related to ImmunoGen’s product candidates; and the presentation of pre-clinical and clinical data on ImmunoGen’s product candidates. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. Various factors could cause ImmunoGen’s actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward- looking statements, which are current only as of the date of this release. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the timing and outcome of ImmunoGen’s pre-clinical and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical studies, clinical trials, and regulatory processes; ImmunoGen’s ability to financially support its product programs; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting impact on ImmunoGen’s industry and business; and other factors more fully described in ImmunoGen’s Annual Report on Form 10-K for the year ended December 31, 2019 and other reports filed with the Securities and Exchange Commission. |
| CONFIDENTIAL 3 Agenda IMGN632 BPDCN Data Review Path to Full Approval in BPDCN IMGN632 AML Progress Update BPDCN Landscape 1 2 3 4 Concluding Remarks and Q&A 5 BPDCN: blastic plasmacytoid dendritic cell neoplasm; AML: acute myeloid leukemia |
| CONFIDENTIAL 4 BPDCN Landscape and IMGN632 Data at ASH Naveen Pemmaraju, MD MD Anderson Cancer Center Associate Professor, Department of Leukemia IMGN632 Lead BPDCN Investigator |
| CONFIDENTIAL 5 BPDCN Landscape • BPDCN is a rare, aggressive hematologic malignancy characterized by historically poor overall survival and limited therapeutic options • Overexpression of CD123 (IL-3Rα) is present in all BPDCN cases, thereby establishing this surface marker as a rational target for therapeutic intervention • Despite the approval of ELZONRIS® (tagraxofusp- erzs), outcomes remain poor in the setting of relapsed and refractory (R/R) BPDCN and novel approaches are urgently needed 500 to 1,000 ESTIMATE OF THE INCIDENCE OF NEWLY DIAGNOSED BPDCN PATIENTS IN THE US ANNUALLY1; 60-70% BECOME R/R 1MDAnderson.org 2019; Pagano Haematologica 2013; Leukemia Lymphoma Society LLS.org. |
| CONFIDENTIAL 6 IMGN632: Novel CD123-Targeting ADC Active in BPDCN and AML • Novel Anti-CD123 Antibody – High affinity binding to CD123 – Unique epitope in extracellular domain • Novel IGN Payload (DGN549)1 – DNA-alkylating activity, single strand DNA breaks (vs. double strand) – Uniform drug antibody ratio (DAR=2) • Novel Peptide Linker – Confers greater stability in circulation – Efficient intracellular payload release 1: ADC binds target 2: ADC internalized 3: Payload released 4: Payload alkylates DNA 1 2 3 4 1Kovtun Blood Adv 2018; 2ASH 2019 Oral Presentation; Daver, N., et al. IGN: indolinobenzodiazepine; DAR: drug:antibody ratio; ORR: overall response rate; RP2D: recommended phase 2 dose IMGN632 demonstrated 22-40% ORR in R/R AML at the RP2D of 0.045 mg/kg every 3 weeks, in subgroups of de novo and relapsed patients and a 33% (3 of 9) ORR in R/R BPDCN2 |
| CONFIDENTIAL 7 ASH 2020 Data: Phase 1/2 801 Study Patient Characteristics (n=29) Age years, median (range) 72y (19-82) Gender, % (n) Male 76% (22) Female 24% (7) Disease, % (n) Compartment involvement Skin 69% (20) Bone marrow 62% (18) Lymph node/visceral 52% (15) Prior/concurrent malignancy 24% (7) Baseline status, % (n) First relapse 21% (6) Primary refractory 59% (17) Relapsed 17% (5) Untreated 3% (1) Prior therapy, % (n) Pts with >2 prior therapies 45% (13) Prior Intense therapies 52% (15) Prior exposure to tagraxofusp-erzs 45% (13) Prior allogeneic stem cell transplant 24% (7) ASH 2020 Oral Presentation; Pemmaraju, N., et al. |
| CONFIDENTIAL 8 ASH 2020 Data: Phase 1/2 801 Study Favorable Safety Profile (n=29) The most common grade ≥3 adverse events (AEs) were thrombocytopenia, febrile neutropenia, and hyperglycemia (10% each) • Rare liver-related AEs: – One (3%) grade ≥3 LFT elevation: grade 3 for >7 days (DLT), resolved – One (3%) grade 3 hyperbilirubinemia and weight gain: “grade 2 clinical VOD” resolved and went to transplant ASH 2020 Oral Presentation; Pemmaraju, N., et al. AE: adverse event; LFT: liver function tests; DLT: dose limiting toxicity; VOD: veno-occlusive disease; TEAEs: treatment emergent adverse events NO NO NO Drug Related Deaths 30-Day Mortality 0% Drug Related Discontinuations Capillary Leak Syndrome (CLS) Adverse events seen in >15% of patients |
| CONFIDENTIAL 9 ASH 2020 Data: Phase 1/2 801 Study Efficacy in R/R BPDCN • In all R/R BPDCN patients: – Overall response rate (ORR) 29% (8/28, 2 CR, 2 CRc*, 1 CRi, 3 PR) – Composite complete remission rate (CCR#) of 18% (5/28) • Importantly, in patients with prior tagraxofusp exposure: – ORR was 31% (4/13, 1 CR, 1CRi, 2 PR) – CCR of 15% (2/13) • Among 15 patients with bone marrow response assessment to date, 60% (9/15) achieved a bone marrow complete remission (blasts <5%), most (78%, 7/9) also achieving an overall response CR: complete response; *CRc: clinical CR = CR criteria EXCEPT limited residual skin disease “marked clearance of all skin lesions from baseline; residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed)” CRi: complete remission with incomplete hematologic recovery; PR: partial response; #CCR: CR+CRc+Cri ASH 2020 Oral Presentation; Pemmaraju, N., et al. |
| CONFIDENTIAL 10 ASH 2020 Data: Phase 1/2 801 Study Time on Treatment and Response • Responses are often rapid: mean time to response 1.1 months (range 0.7-3.5) • 39% (11/28) remain on treatment • Durable responses seen (up to 9.2 months) without transplant ASH 2020 Oral Presentation; Pemmaraju, N., et al. SCT: Stem Cell Transplant; MDS: myelodysplastic syndrome CLAG-M: cladribine, cytarabine, and filgrastim with mitoxantrone or without mitoxantrone (CLAG); PET: positron emission tomography; BM: bone marrow SCT SCT 69 year old female with MDS/BPDCN, refractory to tagraxofusp, CLAG-M, CLAG and presented with extensive skin/PET/BM involvement |
| CONFIDENTIAL 11 Advancing IMGN632 in BPDCN and Relapsed/Refractory AML Anna Berkenblit, MD SVP and Chief Medical Officer ImmunoGen |
| CONFIDENTIAL 12 BPDCN Regulatory Update: Path to Full Approval TYPE B MEETING HELD WITH FDA THIS QUARTER ALIGNED ON PATH TO FULL APPROVAL IN BPDCN Add a pivotal cohort of up to 20 frontline patients to support a label covering all BPDCN patients SAP designed to exclude null hypothesis of 10% CR/CRc rate deemed acceptable Proposed safety database combining AML and frontline and R/R BPDCN patients deemed adequate 801 STUDY Largest-to-date prospective group of uniformly treated patients in R/R BPDCN Granted Breakthrough Therapy Designation in R/R BPDCN from FDA Received Orphan Drug Designation in BPDCN from FDA and EMA |
| CONFIDENTIAL 13 Path to Full Approval in BPDCN: 801 Pivotal Cohort Design SINGLE-ARM PIVOTAL COHORT FOR IMGN632 IN FRONTLINE BPDCN BLA IN 2022 TARGET TIMELINES PRIMARY ENDPOINT CR plus CRc SECONDARY ENDPOINT Duration of CR/CRc ENROLLMENT AND KEY ELIGIBILITY Up to 20 frontline patients Includes patients with prior local therapy Patients ≥18 years old CD123+ by flow cytometry or IHC No minimum serum albumin required CONDUCTED IN THE US & EU ENROLLMENT and TOPLINE DATA 12-18 MONTHS IHC: immunohistochemistry SUPPORTING DATA 3 patients previously enrolled in Study 801 meet the eligibility criteria for the frontline cohort 2 of these 3 patients have achieved CR/CRc |
| CONFIDENTIAL 14 Path Forward in AML: IMGN632 in Combination ALL REGIMENS ACTIVE NO DLTs in TRIPLET ENROLLING PATIENTS DATA ANTICIPATED M I D 2 0 2 1 DOSE ESCALATION AND EXPANSION COHORTS2 In CD123+ AML patient-derived xenograft models, the triplet combination significantly improved survival compared to VEN+AZA • In a model sensitive to VEN+AZA, the triplet demonstrated significant improvement in survival • In two models refractory to VEN+AZA, the triplet demonstrated the potential to overcome VEN+AZA resistance PRE-CLINICAL COMBINATION DATA1 1ASH 2020 Poster; Kuruvilla, V., et al. VEN: venetoclax; AZA: azacitidine. 2ASH 2020 Poster; Daver, N., et al. |
| CONFIDENTIAL 15 Concluding Remarks Mark Enyedy President and Chief Executive Officer ImmunoGen |
| CONFIDENTIAL 16 IMGN632 Summary POTENTIAL BEST-IN-CLASS THERAPEUTIC FOR BPDCN ALIGNED WITH FDA ON PATHWAY TO FULL APPROVAL CONTINUE TO EVALUATE IN COMBINATION IN R/R AML OPPORTUNITY FOR SECOND MARKETED PRODUCT WITHIN 12 MONTHS OF MIRVETUXIMAB LAUNCH |
| CONFIDENTIAL 17 Q&A |
