On July 19, 2023 NANOBIOTIX (Euronext: NANO — NASDAQ: NBTX – the "Company"), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that the first patient has been injected in a Phase 1/2 study evaluating NBTXR3 activated by radiation therapy in combination with anti-PD-1/L-1 immune checkpoint inhibitors for the treatment of patients with advanced solid tumor malignancies that have spread to lungs (lung metastases) and/or liver (liver metastases) (Press release, Nanobiotix, JUL 19, 2023, View Source [SID1234633318]). The trial (NCT05039632) is being conducted as part of an ongoing strategic collaboration between Nanobiotix and The University of Texas MD Anderson Cancer Center evaluating radiotherapy-activated NBTXR3 across solid tumor indications and treatment combinations.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Fundamental in the effort to bring the potential benefits of NBTXR3 to millions of patients around the world is an expansive development program that pushes the scientific boundaries of oncology," said Leonard A. Farber, MD, Chief Clinical and Medical Affairs Officer at Nanobiotix. "This collaboration expands development of NBTXR3 across solid tumor indications, therapeutic combinations, and treatment modalities in parallel with studies led by Nanobiotix. We are pleased with the momentum we continue to build in our program and look forward to the opportunity to bring NBTXR3 to more patients."

This new study expands the ongoing strategic collaboration to five actively recruiting trials. Beyond the new study, the additional active studies in the collaboration include:

A Phase 2 study of radiotherapy-activated NBTXR3 in combination with anti-PD-1 for patients with recurrent or metastatic head and neck cancer (NCT04862455)
A Phase 1 study of radiotherapy-activated NBTXR3 for patients with inoperable non-small cell lung cancer (NCT04505267)
A Phase 1 study of radiotherapy-activated NBTXR3 for patients with pancreatic cancer (NCT04484909)
A Phase 1 study of NBTXR3 activated by radiotherapy in combination with chemotherapy for patients with esophageal cancer (NCT04615013)
Nanobiotix expects data from the collaboration to be presented in H2 2023.

About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored Phase 1 dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy; and a Phase 3 global registrational study was launched in 2021. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company-sponsored phase I clinical study evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC, or lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations. In 2021, the Company announced an agreement with LianBio to expand development of NBTXR3 into Greater China and other Asian Markets, and in 2023 Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV.

On July 19, 2023 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) met one of its primary endpoints of progression-free survival (PFS) as treatment for newly diagnosed patients with high-risk locally advanced cervical cancer (Press release, Merck & Co, JUL 19, 2023, View Source [SID1234633317]). At a prespecified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with concurrent chemoradiotherapy showed a statistically significant and clinically meaningful improvement in PFS versus concurrent chemoradiotherapy alone.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A favorable trend in overall survival (OS), the trial’s other primary endpoint, was also observed for KEYTRUDA plus concurrent chemoradiotherapy compared to concurrent chemoradiotherapy alone; however, these OS data were not mature at the time of this interim analysis. The trial is continuing and follow-up of OS is ongoing. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Results will be presented at an upcoming medical meeting and will be submitted to regulatory authorities.

"The role of KEYTRUDA is already established in certain patients with persistent, recurrent or metastatic cervical cancer, and these results reinforce our research efforts in earlier stages of disease where there is a greater potential for better outcomes," said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. "We are encouraged by these results that show treatment with KEYTRUDA significantly improved progression-free survival for patients with newly diagnosed high-risk locally advanced cervical cancer. We thank the patients, investigators and our partners at ENGOT and GOG for their important contributions to this study and look forward to sharing these results with the medical community."

"Patients with high-risk locally advanced cervical cancer often have a poor prognosis, with more than half of patients experiencing disease recurrence within two years. However, there have been limited new treatment advances for these patients beyond the current standard of care in the last 20 years," said Prof. Domenica Lorusso, the study’s overall principal investigator, lead investigator for ENGOT, and associate professor of Obstetrics and Gynecology at the Catholic University of Rome. "These results are very encouraging and support the use of pembrolizumab combined with the current standard of care in locally advanced cervical cancer to help address the need for new treatment options beyond chemoradiotherapy alone."

In the U.S., KEYTRUDA has two approved indications in cervical cancer: in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test; and as a single agent, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

About KEYNOTE-A18/ENGOT-cx11/GOG-3047

KEYNOTE-A18, also known as ENGOT-cx11/GOG-3047, is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT04221945) sponsored by Merck and conducted in collaboration with the European Network for Gynaecological Oncology Trial (ENGOT) groups and the GOG Foundation, Inc. (GOG) evaluating KEYTRUDA in combination with EBRT plus concurrent chemotherapy (cisplatin), followed by brachytherapy (also known as concurrent chemoradiotherapy) compared to placebo plus concurrent chemoradiotherapy for the treatment of newly diagnosed high-risk (stage 1B2-2B with lymph node-positive disease, and stage 3-4A with and without lymph node-positive disease) locally advanced cervical cancer where patients are treated with definitive intent. The primary endpoints are PFS and OS, and secondary endpoints include complete response (CR) rate, objective response rate (ORR) and safety. The trial enrolled 1,060 patients who were randomized to receive:

KEYTRUDA (200 mg intravenously [IV]) on Day one of each three-week cycle (Q3W) for five cycles followed by KEYTRUDA 400 mg IV on Day one of each six-week cycle (Q6W) for an additional 15 cycles plus concurrent chemoradiotherapy (cisplatin 40mg/m^2 IV once per week [QW] for five or six weeks plus EBRT followed by brachytherapy with minimum total radiotherapy dose of 90 Gray Units [Gy] for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days [with an extension to a maximum of 56 days for unforeseen delays]); or
Placebo plus concurrent chemoradiotherapy (cisplatin 40mg/m^2 IV QW for five or six weeks plus EBRT followed by brachytherapy with minimum total radiotherapy dose of 90 Gy for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days [with an extension to a maximum of 56 days for unforeseen delays]).

About cervical cancer

Cervical cancer forms in a lower part of the uterus, in cells lining the cervix. All women are at risk for cervical cancer. It is most frequently diagnosed between the ages of 35 to 44. Cervical cancer is the fourth most common cancer in women globally. In the U.S., it is estimated there will be approximately 14,000 new cases of invasive cervical cancer and about 4,000 women will die from cervical cancer in 2023. More than nine out of 10 cervical cancers have been associated with the human papillomavirus (HPV), a common virus that most sexually active people get at some point in their lives. For most people, HPV clears on its own; but for the very few who don’t clear the virus, HPV can lead to cervical cancer later in life. There is no way to know which people who have HPV will develop cancer. A critically important step is having regular cervical cancer screenings and talking with an HCP about prevention.

On July 19, 2023 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported its participation in the fifth annual Glioblastoma Awareness Day, July 19, 2023 in Washington, D.C (Press release, Kintara Therapeutics, JUL 19, 2023, View Source [SID1234633316]). Originally introduced to the Senate by a bipartisan group of U.S. senators, the inaugural Glioblastoma Awareness Day took place on July 17, 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are honored to participate in the Glioblastoma (GBM) Awareness Day and to be joined by patients, advocates, physicians, and politicians to continue to raise awareness for GBM research and advancement," said Robert E. Hoffman, the President and CEO of Kintara Therapeutics. "Our lead asset for GBM, VAL-083, is being evaluated in GBM AGILE. Positive findings may be used to support a New Drug Application ("NDA") to the FDA."

The Global Coalition for Adaptive Research Phase 2/3 clinical trial titled Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) is an international, innovative platform study designed to more rapidly identify and confirm effective therapies for patients with glioblastoma through response adaptive randomization and a seamless Phase 2/3 design. The study, conceived by over 130 key opinion leaders, is conducted under a master protocol, allowing multiple therapies or combinations of therapies from different pharmaceutical partners to be evaluated simultaneously. ClinicalTrials.gov Identifier: NCT03970447. A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma – Full Text View – ClinicalTrials.gov

On July 19, 2023 KayoThera, Inc. ("KayoThera"), an early-stage therapeutics company developing first-in-class, oral, small molecule inhibitors of the retinoid pathway, reported the strengthening of its financial resources through multiple grant awards and expansion of its previously announced Series A financing (Press release, KayoThera, JUL 19, 2023, View Source [SID1234633315]). The expanded financing was led by Accelerator Life Science Partners (ALSP), who also provided Series A funding for KayoThera. With the additional $5.2 million in new equity investments, non-dilutive grant funding, and initial seed funding from the New Jersey Health Foundation, KayoThera’s total financial support to date is $14 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

KayoThera has received grant funding from the National Institutes of Health Small Business Innovation Research (SBIR) program1,2 and the Andy Hill Cancer Research Endowment (CARE) Fund3. In addition, KayoThera secured additional Series A financing in an expansion round led by ALSP that also included participation from BioAdvance, Pier 70 Ventures, and WRF Capital. The additional resources secured by KayoThera will further support the Company’s therapeutic development programs.

"The grant awards are important validation of our development programs, and the expanded Series A financing reflects our investor’s confidence in our ability to innovate oral, small molecule inhibitors of the retinoid pathway," said Mark Esposito, Ph.D., Vice President, R&D, and Co-Founder of KayoThera. "With the additional financial resources announced today, we are well-positioned to advance our lead diabetes and oncology programs, each of which has first-in-class potential in disease indications with large patient populations and significant unmet medical need."

"Our belief that KayoThera offers a compelling investment opportunity and has the potential to transform the treatment of serious metabolic diseases and cancer was the key driver for our initial investment in the Company," said Thong Q. Le, Senior Managing Director of ALSP and CEO of KayoThera. "Since the initial Series A financing in March 2022, KayoThera has made significant progress in advancing its core technology and development programs. The additional funding announced today will allow the Company to continue making exciting advances in innovating small molecule inhibitors of the retinoid pathway and position itself for strategic partnering activity that will further help realize the commercial and clinical value of its science."

The retinoid pathway is known to play critical roles in several serious diseases. For example, the clinical use of retinoid activators leads to both adverse cardiometabolic events such as hyperlipidemias as well as increased cancer rates and faster cancer progression. KayoThera’s unique approach to drugging this pathway is based on biology discovered at Princeton University and represents the first platform to create drug-like retinoid inhibitors.

References
1 NIH NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases) R43DK136420. Grant title: Development of first-in-class antagonists of the retinoid pathway as novel oral therapies for Type 2 Diabetes.
2NIH NCI (National Cancer Institute) R43CA278127. Grant title: Development of first-in-class antagonists of the retinoid pathway as novel oral immunotherapies for solid cancers.
3The Andy Hill Cancer Research Endowment (CARE) Fund FY23-LS-05. Grant title: Development of a First-in-Class Immunotherapy to Treat Advanced Solid Tumors Through IND-Enabling Safety Studies.

The content in this release is the sole responsibility of the authors and does not necessarily represent the official views or imply endorsement of the National Institutes of Health.

On July 19, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that an updated exploratory subgroup analysis from the SIENDO study (NCT03555422) in patients with advanced or recurrent TP53 wild-type endometrial cancer will be presented at the virtual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series (Press release, Karyopharm, JUL 19, 2023, View Source [SID1234633314]). The SIENDO exploratory subgroup data provides further support for the ongoing pivotal Phase 3 study of selinexor as a maintenance therapy following systemic therapy in patients with TP53 wild-type advanced or recurrent endometrial cancer (XPORT-EC-042; NCT05611931).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ASCO Plenary Series Program

Title: Long-term follow up of selinexor maintenance in patients with TP53wt advanced or recurrent endometrial cancer: A pre-specified subgroup analysis from the phase 3 ENGOT-EN5/GOG-3055/SIENDO study.
Presenter: Brian Slomovitz, MD, Mount Sinai Medical Center
Session Date and Time: Tuesday July 25, 2023, 3:00pm – 4:00pm (ET)

This livestream event presented by ASCO (Free ASCO Whitepaper) is free to register at:
View Source

About the EC-042 Study

EC-042 (XPORT-EC-042; NCT05611931) is a global, Phase 3, randomized, double-blind study evaluating selinexor as a maintenance therapy following systemic therapy in patients with TP53 wild-type advanced or recurrent endometrial cancer. The EC-042 Study was initiated in November 2022 and is expected to enroll up to 220 patients who will be randomized 1:1 to receive either a 60 mg, once-weekly, administration of oral selinexor or placebo until disease progression. The primary endpoint of the study is progression free survival (PFS), as assessed by an investigator with overall survival as a key secondary endpoint. Further, in connection with the EC-042 Study, Karyopharm entered into a global collaboration with Foundation Medicine, Inc. to develop FoundationOneCDx, a tissue-based comprehensive genomic profiling test to identify and enroll patients whose tumors are TP53 wild-type.

About the SIENDO Study

Karyopharm’s evaluation of selinexor to treat patients with TP53 wild-type advanced or recurrent endometrial cancer is supported by data from an exploratory subgroup analysis from its ongoing SIENDO Study. The SIENDO Study (ENGOT-EN5/GOG-3055) is a multicenter, randomized, double-blinded Phase 3 study evaluating the efficacy and safety of oral selinexor versus placebo as a front-line maintenance therapy in patients with advanced or recurrent endometrial cancer following at least one prior platinum-based combination chemotherapy treatment (NCT03555422). Patients in this study with advanced or recurrent disease who had a partial response or a complete response after at least 12 weeks of taxane-platinum combination chemotherapy were randomized 2:1 to receive either maintenance therapy of 80 mg of selinexor or placebo taken once per week, until disease progression or death. The primary endpoint in the study is PFS from time of randomization until death or disease progression as assessed by an investigator, and prespecified exploratory endpoints included evaluation by p53 status and other molecular subtypes. Early data was presented at European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Plenary and Society for Gynecologic Oncology (SGO) meetings in 2022 and will be reported in future publications.

About Endometrial Cancer

Endometrial cancer is the most common cancer of the female reproductive organs in the U.S., with approximately 66,000 new cases expected in 2023 leading to nearly 13,000 deaths.1 In 2020, there were approximately 130,000 new cases and 29,000 deaths in Europe from endometrial cancer, while on a global scale there were 417,000 new cases and approximately 97,000 deaths.2 Since 2002, the incidence of new cases and deaths from endometrial cancer have risen.3 Risk factors include obesity, Type 2 diabetes, high-fat diets, use of tamoxifen and oral estrogens, and delayed menopause.4 There are no approved therapies in the maintenance setting for patients with advanced or recurrent endometrial cancer. 5

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of Karyopharm’s Selective Inhibitor of Nuclear Export (SINE) compounds to be approved for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved in the U.S. and marketed by Karyopharm in multiple oncology indications, including: (i) in combination with Velcade (bortezomib) and dexamethasone (XVd) in patients with multiple myeloma after at least one prior therapy; (ii) in combination with dexamethasone in patients with heavily pre-treated multiple myeloma; and (iii) in patients with diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. XPOVIO (also known as NEXPOVIO in certain countries) has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including but not limited to the European Union, the United Kingdom, China, South Korea, Canada, Israel and Taiwan. XPOVIO and NEXPOVIO is marketed by Karyopharm’s partners, Antengene, Menarini, Neopharm and FORUS, in China, South Korea, Singapore, Australia, Hong Kong, Germany, Austria, Israel and Canada.

Please refer to the local Prescribing Information for full details.

Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high unmet need cancer indications, including in endometrial cancer and myelofibrosis.

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]

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.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1–888–209–9326 or FDA at 1–800–FDA–1088 or www.fda.gov/medwatch.