On November 3, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the third quarter ended September 30, 2021, and provided a corporate update (Press release, BioCryst Pharmaceuticals, NOV 3, 2021, View Source [SID1234594254]).

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"With the significant revenue of $115 million to $120 million we expect to generate with ORLADEYO in its first year of launch, and an even larger fast-following pipeline that includes four separate indications currently in pivotal or proof of concept trials in the complement space with BCX9930, BioCryst plans to repeat our clinical and commercial success with ORLADEYO again and again as we bring these much-needed oral medicines to the patients who are waiting for them," said Jon Stonehouse, president and chief executive officer of BioCryst.

Program Updates and Key Milestones

ORLADEYO (berotralstat): Oral, Once-daily Treatment for Prevention of Hereditary Angioedema (HAE) Attacks

U.S. Launch

"Almost a year into the launch of ORLADEYO, we continue to see strong, consistent demand from new patients switching to ORLADEYO from their existing injectable prophylactic and acute therapies, and it is exciting to see the positive impact ORLADEYO is having on their lives. With the excellent start to the launch, and the excitement we hear from physicians and patients, ORLADEYO is now on a trajectory to become the market leader in HAE prophylaxis," said Charlie Gayer, chief commercial officer of BioCryst.

ORLADEYO net revenue in the third quarter of 2021 was $37.0 million.

New patient demand for ORLADEYO remains strong and consistent with as many new patients added in Q3 as in Q2.

Patient switches continue to drive the launch with more than half of patients who were new to ORLADEYO in the third quarter switching from other prophylactic medicine to ORLADEYO and the remainder from acute-only treatment.

The number of new physicians prescribing ORLADEYO grew by another 25 percent in the third quarter and the ORLADEYO prescriber base has now increased to include nearly half of the top 500 hereditary angioedema (HAE)-treating physicians in the United States.

ORLADEYO has been very well received by payors and is now covered by nearly all national and regional pharmacy benefit managers.

Most patients continue to have an excellent experience on ORLADEYO and remain on therapy. Through the launch thus far, patient retention on therapy remains consistent with the one-year patient retention rate observed in the APeX-2 clinical trial.
ORLADEYO: Global Updates

ORLADEYO has received reimbursement approval in Norway and is expected to launch in Norway in early December.

On September 15, 2021, the company announced that the United Kingdom’s National Institute for Health and Care Excellence had recommended ORLADEYO for preventing recurrent attacks of HAE in eligible patients 12 years and older if they have at least two attacks per month.

On September 9, 2021, the company announced that the Ministry of Health and Prevention in the United Arab Emirates (UAE) had granted marketing authorization for ORLADEYO for the prevention of recurrent attacks in patients with HAE 12 years and older. To support commercialization efforts in the UAE, BioCryst has entered into a supply and distribution agreement with NewBridge Pharmaceuticals, which also covers the Gulf Cooperation Council and Iraq.

On August 25, 2021, the company announced that the new drug submission for ORLADEYO had been accepted for review by Health Canada for the prevention of recurrent attacks in patients with HAE 12 years and older. The company also announced that Swissmedic has accepted BioCryst’s marketing authorization application for ORLADEYO for review.
Complement Oral Factor D Inhibitor Program – BCX9930

Trial site start-up activities are underway at sites around the world for REDEEM-1 and REDEEM-2, two pivotal trials with the company’s oral Factor D inhibitor, BCX9930, in patients with paroxysmal nocturnal hemoglobinuria (PNH). REDEEM-1 is a randomized, open-label, active, comparator-controlled comparison of the efficacy and safety of BCX9930 (500 mg bid) monotherapy in approximately 81 PNH patients with an inadequate response to a C5 inhibitor. REDEEM-2 is a randomized, placebo-controlled trial to evaluate the efficacy and safety of BCX9930 (500 mg bid) as monotherapy versus placebo in approximately 57 PNH patients not currently receiving complement inhibitor therapy. The primary endpoint for both trials is the change from baseline in hemoglobin, assessed at weeks 12 to 24 in REDEEM-1 and at week 12 in REDEEM-2. Patient enrollment is expected to begin in the fourth quarter of 2021.

In the fourth quarter of 2021, the company also is preparing to initiate a proof of concept trial of oral BCX9930 (500 mg bid) in renal complement-mediated diseases. The trial will be a basket study to evaluate BCX9930 for the potential to treat patients with C3 glomerulopathy, IgA nephropathy and primary membranous nephropathy.

The company has completed a proof of concept trial in patients with PNH, including both treatment-naïve and those patients with an inadequate response to C5 inhibitors. Patients on BCX9930 have been allowed to roll over with continued follow-up into a long-term safety trial. The safety and efficacy data collected from these patients in the long-term safety trial provides the company with a high degree of confidence for the success of the pivotal trials.
Additional Updates

On September 20, 2021, the company announced the appointment of Amy McKee, M.D. to the BioCryst board of directors.

On September 1, 2021, the company announced that the U.S. Department of Health and Human Services had exercised its option to purchase an additional 10,000 doses of BioCryst’s antiviral influenza therapy, RAPIVAB (peramivir injection), for approximately $7 million.

On August 26, 2021, the company announced the appointment of Steven Galson, M.D., MPH to the BioCryst board of directors.

On July 28, 2021, the company announced the appointment of Vincent Milano to the BioCryst board of directors.
Third Quarter 2021 Financial Results

For the three months ended September 30, 2021, total revenues were $41.0 million, compared to $6.1 million in the third quarter of 2020. The increase was primarily due to $37.0 million in ORLADEYO net revenue in the third quarter of 2021.

Research and development expenses for the third quarter of 2021 increased to $50.0 million from $30.2 million in the third quarter of 2020, primarily due to increased investment in the development of BCX9930 and other research, preclinical and development costs, offset by a reduction in spend on the ORLADEYO program following our commercial launch in December 2020.

Selling, general and administrative expenses for the third quarter of 2021 increased to $35.0 million, compared to $17.2 million in the third quarter of 2020. The increase was primarily due to increased investment to support the U.S. commercial launch of ORLADEYO and expanded international operations.

Interest expense was $14.1 million in the third quarter of 2021, compared to $2.9 million in the third quarter of 2020. The increase was due to service on the royalty and debt financings, which were completed in December 2020. The interest payment-in-kind (PIK) option on the Athyrium term loan has been exercised and $5.4 million has been added in the third quarter of 2021 and $12.9 million since issuance, to the $125 million principal.

Net loss for the third quarter of 2021 was $58.8 million, or $0.33 per share, compared to a net loss of $46.1 million, or $0.26 per share, for the third quarter of 2020.

Cash, cash equivalents, restricted cash and investments totaled $203.9 million at September 30, 2021, compared to $148.5 million at September 30, 2020. Operating cash use for the third quarter of 2021 was $18.8 million.

Financial Outlook for 2021

Based on the strength of the ORLADEYO launch, and continued growth from new patient demand expected in the fourth quarter, the company now expects full year 2021 net ORLADEYO revenue to be between $115 million and $120 million. Based on our expectations for revenue, operating expenses, and our option to access an additional $75 million from our existing credit facility, we believe our current cash runway takes us into 2023.

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 2592545. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 2592545.

On November 3, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company using its ARCUS genome editing platform to develop allogeneic CAR T and in vivo gene editing therapies, reported that it will publish financial results for the third quarter 2021 and provide a business update on November 10, 2021 (Press release, Precision Biosciences, NOV 3, 2021, View Source [SID1234594253]).

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Precision BioSciences also announced that Michael Amoroso, Chief Executive Officer will participate in a fireside chat at the Stifel 2021 Virtual Healthcare Conference taking place November 15-17, 2021.

Details for the fireside chat are below:

Stifel 2021 Virtual Healthcare Conference
Date: Tuesday, November 16, 2021
Time: 1:20 PM ET

A live webcast of the fireside chat will be accessible on the Company’s website in the Investors section under Events & Presentations: View Source An archived replay of the webcast will be available for approximately 30 days.

On November 3, 2021 Alkermes plc (Nasdaq: ALKS) reported plans to present a poster related to nemvaleukin alfa (nemvaleukin), the company’s novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, taking place Nov. 10-14, 2021 (Press release, Alkermes, NOV 3, 2021, View Source [SID1234594252]). The poster will include data from the ION-01 study, a phase 2 trial evaluating intravenous nemvaleukin in combination with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma that had previously progressed on an anti-PD-(L)1 therapy.

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Details of the presentation are as follows:

Abstract: 432
Title: Nemvaleukin alfa, a novel engineered IL-2 cytokine, in combination with the anti-PD-1 antibody pembrolizumab in patients with recurrent/metastatic head and neck squamous cell carcinoma (ION-01 study)
Presenter: Brian Gastman, M.D., Surgical Director, Melanoma & High-Risk Skin Cancer Program at the Cleveland Clinic, Cleveland, Ohio
Presentation Date: The poster and presentation will be available on the SITC (Free SITC Whitepaper) virtual meeting platform beginning Nov. 12, 2021. The poster is scheduled to be presented onsite at the meeting on Nov. 13, 2021.

About Nemvaleukin Alfa ("nemvaleukin")
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to preferentially expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by selectively binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the Nemvaleukin Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Ongoing trials in the ARTISTRY program include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3, ARTISTRY-6 and ARTISTRY-7.

ION-01 is a phase 2 trial being conducted in collaboration with Fred Hutchinson Cancer Research Center and is designed to estimate the response rate to intravenous nemvaleukin in combination with the anti-PD-1 therapy pembrolizumab in patients with advanced or recurrent head and neck squamous cell carcinoma who did not achieve complete remission with an anti-PD-(L)1 antibody treatment.

On November 3, 2021 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported financial results for the quarter ended September 30, 2021 and provided business highlights (Press release, Karyopharm, NOV 3, 2021, View Source [SID1234594251]).

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"Driven by acceleration in demand growth for XPOVIO, Karyopharm delivered a strong third quarter, which saw a significant increase in net product revenues versus the second quarter of 2021. XPOVIO continues to move into earlier lines of therapy in multiple myeloma as a new and effective modality that can become the standard of care in second line plus where utilizing new mechanisms is critical to improve patient outcomes," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "With respect to the pipeline, we remain focused on expanding key clinical trials in multiple myeloma, as well as in additional cancer indications such as endometrial cancer, myelodysplastic syndromes and myelofibrosis, as emerging data continue to guide our clinical programs. Looking ahead, we have several key upcoming milestones including reporting top-line data from the Phase 3 SIENDO study in endometrial cancer where recruitment remains on track. Finally, we look forward to hosting an Investor Day in early December to present further details on our commercial and pipeline priorities."

Third Quarter 2021 and Recent Highlights

XPOVIO Commercial Performance

Achieved U.S. net product revenue for the third quarter of 2021 of $26.7 million. This represents 32% growth compared to the second quarter of 2021 and 25% growth compared to the third quarter of 2020.
Moving into earlier lines of treatment and increasing use of once weekly XPOVIO-based triplet regimen.
Growing breadth and depth of adoption and building physician confidence in the community with the new, once weekly, lower dose XPOVIO-based triplet regimen.
Payer coverage remains robust at 97%.
R&D Highlights for Selinexor and Eltanexor

Hematologic Malignancies: Karyopharm is actively building its hematologic oncology franchise through several key initiatives, including pursuing NEXPOVIO (selinexor) marketing approval in Europe in the second-line plus treatment setting for multiple myeloma, expanding approved multiple myeloma indications in the U.S. to include combinations with certain approved therapies, and pursuing additional high unmet need indications beyond multiple myeloma, such as myelofibrosis (MF) and myelodysplastic syndromes (MDS).

European Medicines Agency has validated the Marketing Authorization Application (MAA) for NEXPOVIO in combination with Velcade (bortezomib) and low-dose dexamethasone for the treatment of multiple myeloma following at least one prior therapy. The MAA will be reviewed by the Committee for Medicinal Products for Human Use, which will issue an opinion to the European Commission regarding the potential approval for the expanded indication. Karyopharm expects this review to be completed in the first half of 2022.
Commenced dosing in the Phase 2 expansion of an ongoing Phase 1/2 study evaluating eltanexor, Karyopharm’s novel oral selective inhibitor of nuclear export (SINE) compound, in patients with intermediate or high-risk hypomethylating agents refractory MDS (KPT-8602-801; NCT02649790).
Commenced dosing in a new Phase 1/2 study evaluating selinexor in combination with Jakafi (ruxolitinib) in patients with treatment-naïve myelofibrosis (XPORT-MF-034; NCT04562389).
XPOVIO in Solid Tumors: The Company is exploring solid tumor indications for XPOVIO, either alone or in combination with other agents, including in endometrial cancer, glioblastoma, melanoma, colorectal cancer and non-small cell lung cancer.
Enrollment in the Phase 3 SIENDO study in patients with endometrial cancer remains on track; expecting to report top-line results by the end of 2021 or early 2022.
Commenced dosing in a new Phase 2 study evaluating selinexor in combination with Keytruda (pembrolizumab) in patients with locally advanced or metastatic melanoma (XPORT-MEL-033; NCT04768881).
Corporate and Business Highlights

Earned $10 million in milestone payments from Antengene Therapeutics Limited (Antengene) in the third quarter of 2021 following the July 2021 approval of selinexor in South Korea for the treatment of patients with multiple myeloma and diffuse large B-cell lymphoma (DLBCL).
Karyopharm to host a virtual Investor Day on Wednesday, December 8, 2021 from 10:00 a.m. to 12:30 p.m. ET to outline commercial and pipeline priorities and objectives. The event will feature presentations from Karyopharm management and recognized thought leaders in multiple myeloma, gynecological malignancies, and other core focus indications. The event will take place virtually and will be accessible via conference call and webcast. Full details will be made available closer to the Investor Day.
Third Quarter 2021 Financial Results

"We are pleased with the continued expansion of our international program in the third quarter, which was highlighted by our progressing partnership with Antengene in South Korea and the subsequent milestone payment received by Karyopharm," said Michael P. Mason, Chief Financial Officer of Karyopharm. "Based on our current operating plans, we believe our cash, cash equivalents and investments, together with growing XPOVIO sales and revenues from existing collaborators, provide us with a cash runway that extends into mid-2023."

Net product revenue: Net product revenue for the third quarter of 2021 was $26.7 million, compared to $21.3 million for the third quarter of 2020.

License and other revenue: License and other revenue for the third quarter of 2021 was $11.0 million. During the third quarter of 2021, Karyopharm recognized $9.8 million pursuant to its agreement with Antengene, following the July 2021 approval of selinexor for the treatment of patients with multiple myeloma and DLBCL in South Korea and $1.2 million of revenue associated with named patient programs.

Cost of sales: Cost of sales for the third quarter of 2021 were $0.6 million, compared to $0.4 million for the third quarter of 2020. Cost of sales reflect the costs of XPOVIO units sold and third-party royalties on net product revenue.

Research and development (R&D) expenses: R&D expenses for the third quarter of 2021 were $45.8 million, compared to $37.0 million for the third quarter of 2020. The increase in R&D expenses in the third quarter of 2021 compared to the third quarter of 2020 was primarily attributable to the acquisition of certain assets from Neumedicines Inc., which closed in the third quarter of 2021.

Selling, general and administrative (SG&A) expenses: SG&A expenses for the third quarter of 2021 were $35.1 million, compared to $31.0 million for the third quarter of 2020. The increase in SG&A expenses in the third quarter of 2021 compared to the third quarter of 2020 was due primarily to increased personnel costs.

Interest expense: Interest expense for the third quarter of 2021 was $8.0 million, compared to $6.8 million for the third quarter of 2020. The increase in interest expense was primarily attributable to a $3.0 million increase in interest expense due to the increased deferred royalty obligation following Karyopharm’s June 2021 amendment of its Revenue Interest Agreement with HealthCare Royalty Management, LLC, partially offset by a $1.8 million decrease in non-cash interest expense related to Karyopharm’s 3.00% senior convertible notes due 2025, as a result of the January 1, 2021 adoption of ASU No. 2020-06, Debt—Debt with Conversion and Other Options and Derivatives and Hedging—Contracts in Entity’s Own Equity.

Net loss: Karyopharm reported a net loss of $51.8 million, or $0.69 per share, for the third quarter of 2021, compared to a net loss of $53.5 million, or $0.73 per share, for the third quarter of 2020. Net loss included non-cash stock-based compensation expense of $7.4 million and $6.5 million for the third quarters of 2021 and 2020, respectively.

Cash position: Cash, cash equivalents, restricted cash and investments as of September 30, 2021 totaled $209.3 million, compared to $276.7 million as of December 31, 2020.

2021 Financial Outlook

Based on its current operating plans, Karyopharm expects the following for full year 2021:

Non-GAAP R&D and SG&A expenses, excluding stock-based compensation expense, are expected to be in the range of $270 million to $290 million. Karyopharm has not reconciled the full year 2021 outlook for non-GAAP R&D and SG&A expenses to full year 2021 outlook for GAAP R&D and SG&A expenses because Karyopharm cannot reliably predict without unreasonable efforts the timing or amount of the factors that substantially contribute to the projection of stock compensation expense, which is excluded from the full year 2021 outlook for non-GAAP R&D and SG&A expenses.
The Company expects that its existing cash, cash equivalents and investments, together with growing XPOVIO sales and revenues from existing collaborators, provide it with a cash runway that extends into mid-2023.
Non-GAAP Financial Information

Karyopharm uses a non-GAAP financial measure, including R&D and SG&A expenses, to provide operating expense guidance. Non-GAAP R&D and SG&A expenses exclude stock-based compensation expense. Karyopharm believes this non-GAAP financial measure is useful to investors because it provides greater transparency regarding Karyopharm’s operating performance as it excludes non-cash stock compensation expense. This non-GAAP financial measure should not be considered a substitute or an alternative to GAAP R&D and SG&A expenses and should not be considered a measure of Karyopharm’s liquidity. Instead, non-GAAP R&D and SG&A expenses should only be used to supplement an understanding of Karyopharm’s operating results as reported under GAAP.

Conference Call Information

Karyopharm will host a conference call today, Wednesday, November 3, 2021, at 8:30 a.m. Eastern Time, to discuss the third quarter 2021 financial results and provide other business highlights. To access the conference call, please dial (888) 349-0102 (local) or (412) 902-4299 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source An archived webcast will be available on the Company’s website approximately two hours after the event.

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. NEXPOVIO (selinexor) has also been granted conditional marketing authorization for adult patients with heavily pretreated multiple myeloma by the European Commission. Karyopharm’s supplemental New Drug Application (sNDA) requesting an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA on December 18, 2020. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at:
Tel: +1 (888) 209-9326
Email: [email protected]

XPOVIO (selinexor) is a prescription medicine approved:

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti–CD38 monoclonal antibody (Xd).
For the treatment of adult patients with relapsed or refractory diffuse large B–cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony–stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo–Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3–4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.
The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3–4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection (21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.
Use In Specific Populations
Lactation: Advise not to breastfeed.

For additional product information, including full prescribing information, please visit www.XPOVIO.com.

On November 3, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported it will host a conference call to discuss the third quarter 2021 financial results and provide a corporate update on Wednesday, November 10, 2021 at 4:30 p.m. Eastern/1:30 p.m. Pacific (Press release, Spectrum Pharmaceuticals, NOV 3, 2021, View Source [SID1234594250]).

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The conference call will also be available from the Investor Relations section of the company’s website at View Source and will be archived there shortly after the live event.