On March 17, 2022 Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing a diversified pipeline of targeted therapies for patients with cancer, reported on recent and upcoming business highlights and announced its financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Cullinan Oncology, MAR 17, 2022, View Source [SID1234610307]).

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"Cullinan Oncology is dedicated to developing new standards of care in cancer therapy and we made considerable progress toward this goal in 2021, including advancing additional programs into the clinic, adding new assets to our pipeline, and deepening our oncology expertise with new additions to our board and leadership team," said Nadim Ahmed, Chief Executive Officer of Cullinan Oncology. "In the fourth quarter of 2021, we reported compelling data from the ongoing Phase 1/2a trial of our lead program, CLN-081. We were also pleased to announce in January of this year that the FDA granted CLN-081 Breakthrough Therapy Designation, a distinction that further supports its differentiated clinical profile in NSCLC patients with EGFR exon 20 insertion mutations. We look forward to providing a regulatory update in the coming weeks."

Mr. Ahmed continued, "Additionally, we initiated clinical trials for two other differentiated oncology programs, CLN-619 and CLN-049, while further expanding our pipeline with the addition of an HPK1 degrader collaboration with the Icahn School of Medicine at Mount Sinai. Finally, we expanded our late-stage oncology expertise and leadership with the recent appointments of Dr. Jeff Jones as Chief Medical Officer and Dr. Anne-Marie Martin as an independent director. Finishing the year with over $430 million of cash and investments, we remain well positioned to continue advancing our broad pipeline of first- and/or best-in-class oncology molecules as we work toward our mission of developing new therapeutic solutions for people living with cancer."

Portfolio Highlights

CLN-081 (Pearl): During the fourth quarter of 2021, Cullinan reported updated Phase 1/2a data for CLN-081 in NSCLC patients harboring epidermal growth factor (EGFR) exon 20 insertion mutations who have previously received platinum-based systemic chemotherapy. The update included safety and efficacy data from 73 patients treated across all five dose levels (30 – 150mg BID). At the 100mg BID dose level, 35 of 36 (97%) response evaluable patients achieved a best response of partial response or stable disease, with 14 (39%) patients achieving a confirmed partial response. Among patients enrolled in the initial Phase 1 cohort at 100mg BID (n=13), the estimated median duration of response was greater than 15 months and the estimated median progression free survival was 12 months. In January 2022, Cullinan announced that CLN-081 received Breakthrough Therapy Designation. Cullinan will provide a regulatory update on CLN-081 in the first quarter of 2022.

CLN-049 (Florentine): CLN-049 is a FLT3/CD3-bispecific T cell-engaging antibody in an IgG format for the treatment of acute myeloid leukemia (AML). CLN-049 targets the extracellular domain of FLT3, regardless of mutant or wild type-based expression. In December 2021, patient dosing was initiated in a first-in-human clinical trial evaluating CLN-049 in patients with relapsed/refractory AML. A more extensive preclinical characterization of CLN-049 has been published in the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (JITC), titled, "A Novel IgG-based FLT3xCD3 Bispecific Antibody for the Treatment of AML and B-ALL." Initial clinical data are expected by mid-2023.

CLN-619 (MICA): CLN-619 is a first-in-class monoclonal antibody that stabilizes MICA/MICB on the tumor cell surface to promote an antitumor response via activation of both natural killer (NK) cells and certain T cells, with broad therapeutic potential across multiple cancer indications. In December 2021, patient dosing was initiated in a first-in-human clinical trial evaluating CLN-619 in patients with advanced tumors. The trial design includes parallel evaluation of CLN-619 as a monotherapy and in combination with checkpoint inhibitor therapy in separate modules. Initial clinical data are expected by mid-2023.

Preclinical Portfolio: Continued advancement of five additional oncology programs with the following highlights:

Preclinical data across five distinct programs will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting, including CLN-049, CLN-619, CLN-617 (Amber), CLN-978 (NexGem) and Opal (additional information can be found in this press release on our company website).

Cullinan recently announced a collaboration with the Icahn School of Medicine at Mount Sinai to develop oral protein degraders targeting hematopoietic progenitor kinase 1 (HPK1), a key regulator of immune cell activation and a high-priority target in immune-oncology. Preclinical research has shown that a degrader approach to targeting HPK1 may be more effective at controlling tumor growth than inhibition of HPK1 kinase activity.

In 2021, Cullinan advanced two programs into IND-enabling studies: CLN-617, a cytokine fusion protein uniquely combining IL-12 and IL-2 with a collagen binding domain for retention in the tumor microenvironment (TME), and CLN-978, a novel CD19/CD3-bispecific construct with extended serum half-life and high potency against target cells expressing very low levels of CD19. Cullinan expects to submit INDs for both programs by the end of the first half of 2023.

Organizational Announcements: Expanded late-stage oncology expertise with appointments of Jeffrey Jones, M.D., MPH, MBA as Chief Medical Officer and Anne-Marie Martin, Ph.D., as an independent director. Dr. Jones joins from Bristol Myers Squibb Company, where he held positions of increasing responsibility in oncology clinical development. Dr. Martin is currently the Senior Vice President, Global Head of the Experimental Medicine Unit at GlaxoSmithKline plc. and joins Cullinan with over 25 years of translational medicine and clinical research expertise.

Fourth Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and investments were $430.9 million as of December 31, 2021. We expect that this balance will be sufficient to fund operations through 2024.

R&D Expenses: Research and development (R&D) expenses were $20.9 million for the fourth quarter of 2021, compared to $12.7 million for the third quarter of 2021. R&D expenses in the fourth and third quarters of 2021 included $2.6 million and $2.5 million of equity-based compensation expenses, respectively. The increase in R&D expenses is primarily related to expanded clinical and chemistry, manufacturing, and controls (CMC) activity for CLN-081 and discovery and development of our preclinical programs.

G&A Expenses: General and administrative (G&A) expenses were $13.5 million for the fourth quarter of 2021, compared to $5.7 million for the third quarter of 2021. G&A expenses in the fourth and third quarters of 2021 included $9.6 million and $2.1 million of equity-based compensation expenses, respectively. The increase in G&A expenses is primarily related to a non-recurring charge to equity-based compensation expense due to the transition of our chief executive officer.

Net Loss: The Company’s net loss (before items attributable to noncontrolling interest) was $34.4 million for the fourth quarter of 2021, compared to $18.4 million for the third quarter of 2021. The increase in net loss related primarily to CLN-081 CMC investment, R&D portfolio advancement, and non-recurring equity-based compensation expenses.

Full Year 2021 Financial Results

R&D Expenses: R&D expenses were $57.8 million for the year ended December 31, 2021, compared to $43.2 million for the year ended December 31, 2020. R&D expenses for the full years 2021 and 2020 included $8.9 million and $5.9 million of equity-based compensation expenses, respectively. The increase in R&D expenses is primarily related to expanded trial enrollment, CMC activities, and a sub-licensing fee relating to CLN-081, as well as increases in pre-clinical and CMC costs to support IND enabling activities for other programs.

G&A Expenses: G&A expenses were $29.1 million for the year ended December 31, 2021, compared to $17.1 million for the year ended December 31, 2020. G&A expenses for the full years 2021 and 2020 included $15.4 million and $9.0 million of equity-based compensation expenses, respectively. The increase in G&A expenses is primarily related to a non-recurring charge to equity-based compensation expense in the fourth quarter due to the transition of our chief executive officer, as well as increased headcount, legal expenses, insurance costs, and IT systems upgrades to support our operations as a public company.

Net loss: The Company’s net loss (before items attributable to non-controlling interest) was $67.5 million for the year ended December 31, 2021, compared to $59.5 million for the year ended December 31, 2020. Net loss for the year ended December 31, 2021 included $18.9 million of revenue from the upfront payment pursuant to the license agreement with Zai Lab (Shanghai) Co., Ltd. for the development and commercialization rights to CLN-081 in Greater China, $3.0 million of sub-licensing expense associated with that transaction, and $24.4 million of non-cash equity-based compensation expense.

On March 17, 2022 IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) ("IntelGenx"), a leader in pharmaceutical films, reported that it will release its fourth quarter and full year 2021 financial results after market close on Thursday, March 24, 2022 (Press release, IntelGenx, MAR 17, 2022, View Source [SID1234610342]).

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An accompanying conference call will be hosted by Dr. Horst G. Zerbe, Chief Executive Officer, and Mr. Andre Godin, President and Chief Financial Officer, to discuss the results and provide a business update. Details of the conference call and webcast are below:

Fourth Quarter and Full Year 2021 Results Conference Call Details:

The call will also be broadcast live and archived on the Company’s website at www.intelgenx.com under "Webcasts" in the Investors section.

On March 16 2022 Terrapeutics Pharma ("Terrapeutics") and the Helmholtz-Institute for Pharmaceutical Research Saarland (HIPS) reported that they have reached a cooperation agreement to co-develop novel natural products that will be the basis for new drugs in two of the most challenging drug targets that are considered the "holy grail" of the pharmaceutical industry (Press release, Helmholtz-Institute for Pharmaceutical Research Saarland (HIPS) , MAR 16, 2022, View Source [SID1234650070]). The HIPS is a joint institution of the Helmholtz Centre for Infection Research (HZI) and Saarland University.

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Some of the most devastating diseases, such as infections with antibiotic resistant bacteria and RAS-driven cancers (pancreatic, colon, and more), are currently undruggable despite detailed knowledge of the underlying molecular mechanisms. While industry leaders agree that small bioactive molecules produced by microorganisms have a tremendous potential to solve this therapeutic challenge, current methodologies can test only 0.1% of their potential. The staggering 99.9% are unexplored and considered "dark matter" to pharma companies.

Under this collaboration, Terrapeutics will utilize its ground breaking technology to screen and select microorganisms that produce small molecule inhibitors targeted against resistant bacteria and oncogenic RAS. HIPS will utilize its expertise to isolate, characterize and optimize the newly discovered novel molecules for their use in humans.

Dr. Ariel Werman CSO & Co-Founder of Terrapeutics said: "This agreement represents an important milestone in Terrapeutics road to become a world leader in natural molecule-based drug discovery, focusing on undruggable targets. Our revolutionary technology, enables us to look at the 99.9% fraction of the naturally produced molecules that the pharmaceutical industry is blind to, and rapidly, selectively and accurately pick microorganisms that produce molecules that respond to specific drug targets. It is as if we are performing a high throughput screening against a specific drug target, using nature as our library of compounds"

Mr. Eddie Sadan CEO & Co-Founder of Terrapeutics added that "this is a strategic engagement with a world leading research institute in the field of natural molecules for Pharmaceutical use that leverages our innovative approach to this field together with HIPS outstanding capabilities and knowledge to solve two of the biggest challenges the pharmaceutical industry faces".

Prof. Dr. Rolf Muller, Managing Director at the HIPS, commented: "We are intrigued to jointly evaluate the potential of Terrapeutics technology for the isolation of bacteria producing specific natural products. If we can manage to specifically isolate those bacteria that make the compounds we are looking for, we can skip a very time- and cost-intensive part of the usual drug development process. This would bring us a big step forwards in the fight against antimicrobial resistance (AMR) and other diseases threatening global human health."

On March 16, 2022 Precirix NV, a clinical-stage biotechnology company developing precision radiopharmaceuticals in oncology, reported the closing of a EUR 80m Series B financing round led by new investors INKEF Capital, Jeito Capital and Forbion as co-leads (Press release, Precirix, MAR 16, 2022, View Source [SID1234610152]).

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"We are delighted to announce this major milestone and are grateful for the strong investor support. The addition of Inkef, Jeito and Forbion, three leading VC funds in the healthcare sector, significantly reinforces our international shareholder base," said Ruth Devenyns, CEO of Precirix. "The investment will allow Precirix to accelerate its growth trajectory and to further validate and broaden the technology platform."

Precirix’s platform brings together several unique features and facilitates the development of radiolabelled single-domain antibodies (sdAbs) for multiple targets, in combination with different isotopes and applicability in various settings. The company’s lead product candidate, CAM-H2, is currently in a Phase I/II study for the treatment of HER2-positive metastatic breast and gastric cancer. The study allows inclusion of patients with brain metastases, a population in urgent need of effective therapies. Initial imaging data provide confidence in the potential of CAM-H2 to address the unmet medical need in this population. Patients are now being enrolled in the second cohort of the dose-escalation phase, following the absence of any dose-limiting toxicities in the first cohort and a positive review from the Safety Review Committee.

The proceeds of this financing round will fund the development and expansion of Precirix’s pipeline. More specifically, the company will advance CAM-H2 through its ongoing Phase I/II study, and plans to bring additional novel radiopharmaceuticals to the clinic. Precirix will also focus on further strengthening the platform, using its potential to generate new product candidates, linkers and CMC processes.

Simone Botti, Partner at INKEF Capital, Sabine Dandiguian, Managing Partner at Jeito and Jasper Bos, General Partner at Forbion Growth will join Precirix’s Board of Directors.

Simone Botti, Partner at INKEF Capital said, "Radiopharmaceuticals are showing great promise as therapies for difficult-to-treat cancers. Precirix’s innovative platform based on sdAb carriers has potential to truly improve clinical outcomes for patients. We are excited to support Precirix on its continued progress advancing first in class targeted radiopharmaceuticals towards commercialization."

Sabine Dandiguian, Managing Partner at Jeito Capital said, "We are thrilled to co-lead this round with the ambition to support Precirix in bringing a breakthrough new alternative to patients suffering from advanced cancer, in total coherence with Jeito’s mission: ‘Go faster for the patient, further with the entrepreneur’."

Jasper Bos, General Partner at Forbion, working in the company’s Growth Fund noted, "Forbion Growth was launched with the aim to build a portfolio of 10-12 investments in the most promising European late-stage life sciences companies. Precirix exemplifies the type of company we invest within the fund. I am confident of our ability to enable the team to build and transform patients’ lives."

The company’s existing shareholders Gimv, HealthCap, Novo Holdings, Pontifax Venture Capital, V-Bio Ventures, BioMed Partners, as well as the seed investors, continue to support the company having all participated in the round

On March 16, 2022 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that results from the Phase 3 SIENDO study will be presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper)’s (ESMO) (Free ESMO Whitepaper) Virtual Plenary taking place on Thursday, March 17, 2022 (Press release, Karyopharm, MAR 16, 2022, View Source [SID1234610172]). The data will also be presented in a late-breaking abstract at the Society for Gynecologic Oncology (SGO) 2022 Annual Meeting on Women’s Cancer taking place March 18-21, 2022, in Phoenix, Arizona.

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Details for the presentations are as follows:

ESMO Virtual Plenary:

Title: Prospective double-blind, randomized phase III ENGOT-EN5/GOG-3055/SIENDO study of oral selinexor/placebo as maintenance therapy after first-line chemotherapy for advanced or recurrent endometrial cancer
Presenter: Professor Ignace Vergote, MD, PhD, Leuven University Hospitals, Leuven, Belgium
Date and Time: Thursday, March 17, 2022, 6:00pm-7:00pm CET/1:00pm-2:00pm ET

SGO 2022 Annual Meeting on Women’s Cancer:

Title: Prospective double-blind, randomized phase III ENGOT-EN5/GOG-3055/SIENDO study of oral selinexor/placebo as maintenance therapy after first-line chemotherapy for advanced or recurrent endometrial cancer
Presenter: Professor Ignace Vergote, MD, PhD, Leuven University Hospitals, Leuven, Belgium
Session Type: Oral Presentation
Session: Scientific Plenary IV: Late-Breaking Abstracts
Date and Time: Saturday, March 19, 2022, 5:19pm-5:27pm MT/7:19pm-7:27pm ET

Conference Call Information
Karyopharm will host a conference call Thursday, March 17, 2022, at 4:30 p.m. Eastern Time, to discuss the SIENDO study results. 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, along with accompanying slides, 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 the SIENDO Study

The Phase 3 SIENDO study (ENGOT-EN5/GOG-3055) is a multicenter, blinded, placebo-controlled, randomized study evaluating the efficacy and safety of selinexor as a maintenance therapy following chemotherapy in patients with advanced or recurrent endometrial cancer. The study enrolled 263 patients with primary stage IV or recurrent disease who had a partial or complete response after at least 12 weeks of standard taxane-platinum combination chemotherapy. Patients were randomized 2:1 to receive either maintenance therapy of 80mg of selinexor taken once weekly, or placebo, until disease progression. The primary endpoint of the study is statistically significant improvement of progression-free survival compared to placebo. The goal of the study was to demonstrate a hazard ratio of 0.6 or better. In partnership with Karyopharm, the study was initiated by the ENGOT group. In the U.S., the collaboration includes the GOG-F.

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 2022 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 More than 90 percent of uterine body cancers occur in the endometrium, so the actual numbers for endometrial carcinoma cases and deaths are slightly lower than these estimates, which include both endometrial carcinomas and uterine sarcomas. Unlike other cancers that have decreased with preventative measures, endometrial cancer is on the rise.3 Risk factors include obesity, Type 2 diabetes, high-fat diets, use of tamoxifen and oral estrogens, and delayed menopause.4 While the majority of endometrial cancers are diagnosed at early stages, approximately 14,000 patients in the U.S. are diagnosed with advanced disease that cannot be fully removed using surgery.5 These patients, and those with recurrent disease, are treated with chemotherapy. Chemotherapy does not cure patients with endometrial cancer. The use of later lines of chemotherapy are intended to control symptoms rather than cure the disease. There are no approved therapies in the maintenance setting for patients with advanced or recurrent endometrial cancer. The current standard of care is a "watch and wait" approach.6

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 a growing number of ex-U.S. territories and countries, including Europe, the United Kingdom, China, South Korea and Israel, and is marketed in those areas by Karyopharm’s global partners. Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high unmet need cancer indications, including 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]

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 were 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.