A Pilot, Open-label, Randomized, Two-Way Crossover, Single-Dose Bioequivalence Study of Pomalidomide Under Fasting Condition in Indian Healthy Volunteers

Pilot bioequivalence trial of two pomalidomide formulations consisting in 4 mg oral capsules.

Start Date15 Sep 2024

Sponsor / Collaborator

Mega Labs SA

NCT05922501 / Not yet recruitingPhase 2IIT

A Phase II Study of ISABELA: Isatuximab, Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Relapsed and Refractory Multiple Myeloma

The main goal of this phase II study is to evaluate the overall response rate of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma. The study drugs provided for research purposes are isatuximab and belantamab mafodotin.

Start Date18 Jun 2024

Sponsor / Collaborator

The Schwartz Center for Compassionate Healthcare

[+2]

CTR20241042 / RecruitingPhase 3

一项评价SG301 注射液联合泊马度胺和地塞米松对比安慰剂联合泊马度胺和地塞米松治疗复发/难治性多发性骨髓瘤有效性和安全性的随机、对照、双盲、多中心Ⅲ 期临床试验（第一阶段）

[Translation] A randomized, controlled, double-blind, multicenter Phase III clinical trial to evaluate the efficacy and safety of SG301 injection combined with pomalidomide and dexamethasone versus placebo combined with pomalidomide and dexamethasone in the treatment of relapsed/refractory multiple myeloma (Phase I)

评价SG301注射液联合泊马度胺和地塞米松在复发/难治性多发性骨髓瘤患者中的安全性和耐受性。

[Translation]

To evaluate the safety and tolerability of SG301 injection combined with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.

Start Date05 Jun 2024

Sponsor / Collaborator

Hangzhou Shangjian Biotechnology Co., Ltd.Startup

100 Clinical Results associated with Pomalidomide

100 Translational Medicine associated with Pomalidomide

100 Patents (Medical) associated with Pomalidomide

1,087

Literatures (Medical) associated with Pomalidomide

01 Feb 2024·American journal of hematology

Immunoglobulin light chain amyloidosis: 2024 update on diagnosis, prognosis, and treatment

Article

Author: Gertz, Morie A

Abstract:

Disease Overview:

Immunoglobulin light chain amyloidosis is a clonal, nonproliferative plasma cell disorder in which fragments of immunoglobulin light or heavy chain are deposited in tissues. Clinical features depend on organs involved but can include heart failure with preserved ejection fraction, nephrotic syndrome, hepatic dysfunction, peripheral/autonomic neuropathy, and “atypical smoldering multiple myeloma or MGUS.”

Diagnosis:

Tissue biopsy stained with Congo red demonstrating amyloid deposits with apple‐green birefringence is required for the diagnosis of AL amyloidosis. Organ biopsy is not required in 85% of patients. Verification that amyloid is composed of immunoglobulin light chains is mandatory. The gold standard is laser capture mass spectroscopy.

Prognosis:

N‐terminal pro–brain natriuretic peptide (NT‐proBNP or BNP), serum troponin T(or I), and difference between involved and uninvolved immunoglobulin free light chain values are used to classify patients into four stages; 5‐year survivals are 82%, 62%, 34%, and 20%, respectively.

Therapy:

All patients with a systemic amyloid syndrome require therapy to prevent deposition of amyloid in other organs and prevent progressive organ failure. Current first‐line therapy with the best outcome is daratumumab, bortezomib, cyclophosphamide, and dexamethasone. The goal of therapy is a ≥VGPR. In patients failing to achieve this depth of response options for consolidation include pomalidomide, stem cell transplantation, venetoclax, and bendamustine.

Future Challenges:

Delayed diagnosis remains a major obstacle to initiating effective therapy prior to the development of end‐stage organ failure. Trials of antibodies to deplete deposited fibrils are underway.

01 Feb 2024·American journal of hematology

Two p53s in a Pod: Co‐occurring plasma cell myeloma and therapy‐related myeloid neoplasm following lenalidomide therapy

Author: Monge, Jorge ; Bao, Liming ; Patel, Sanjay S. ; Razavi, Meri

A case of 78-yr-old man with relapsed/refractory IgG-kappa multiple myeloma was electively admitted to the hospital for teclistamab step-up therapy is reported.He had received four prior lines of therapy: bortezomib/lenalidomide/dexamethasone, lenalidomide, daratumumab/ carfilzomib/pomalidomide/dexamethasone, bortezomib/selinexor/dexa- methasone; requiring multiple dose reductions for cytopenias.Fluorescence in situ hybridization detected heterozygous TP53 deletion in myeloma (CD138+) and non-myeloma (CD138) cell fractions.

01 Feb 2024·Bioorganic chemistry

Near-infrared light controlled protein degradation by photo-caged lenalidomide and pomalidomide

Article

Author: Chu, Ling ; Shi, Yinan ; Huang, Weiren ; Liu, Baohua ; Yan, Xiaosa ; Zhu, Yaoji

Immunomodulatory drugs (e.g. thalidomide, lenalidomide and pomalidomide) have been proven highly successful in clinical treatment of multiple myeloma. However, systematic degradation of zinc finger transcriptional factors induced by these drugs could lead to severe systematic toxicity in patients. Previous reports of NVOC caged pomalidomide attempted to regulate its activity using UVA irradiation, but their application was limited by high cytotoxicity and low tissue penetration. Here, we reported red-shifted BODIPY caged lenalidomide and pomalidomide that enabled red-light controlled protein degradation with spatiotemporal precision.

222

News (Medical) associated with Pomalidomide

27 Jun 2024

·www.prnewswire.com

American Cancer Society Projects Over 2 Million New Cases in 2024: Biotech Innovations Respond

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 27, 2024 /PRNewswire/ -- USA News Group News Commentary – According to the American Cancer Society, 2024 will be the first year the USA expects to have more than 2 million new cancer cases. In order to respond to the rising rates of cancer, the National Cancer Institute is making calls for change in how cancer clinical research is performed "Because our patients can't wait." According to Spherical Insights, the Global Oncology Drugs Market is projected to grow by 11.5% CAGR through 2033 to US$564.5 billion, highlighting the need for more effective therapies and incentives for those who develop them. The biotech sector is actively addressing this need, with recent notable developments from several companies, including: O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), GSK plc (NYSE: GSK), Guardant Health, Inc. (NASDAQ: GH), Exelixis, Inc. (NASDAQ: EXEL), and Gilead Sciences, Inc. (NASDAQ: GILD). The article continued: According to the World Health Organization, the global cancer burden is growing amidst a mounting need for services. As well, an alarming trend is emerging, where cancer cases in younger people are rising sharply. Oncolytics Biotech® Announces Productive FDA Type C Meeting on its Metastatic Breast Cancer Program Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that the Company received productive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), supporting the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC). The FDA supports progression-free survival as the primary endpoint of the study, with overall survival as a key secondary endpoint. The Company's proposed study will enroll patients who have failed hormonal therapy and have received no more than one line of antibody-drug conjugate (ADC) therapy. "Aligning with the FDA on key design elements and objectives of our planned registrational trial for pelareorep marks a critical step towards bringing this innovative treatment to patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Our de-risked program builds on compelling data and key learnings from two randomized studies, BRACELET-1 and IND-213, which demonstrated clinically meaningful benefit in patients receiving pelareorep and paclitaxel compared to paclitaxel alone. Additionally, translational data from the AWARE-1 study highlights pelareorep's immune-mediated mechanism of action in breast cancer patients. We are now well-positioned to deliver on our mission of making pelareorep available to breast cancer patients in need of better treatment options." Wayne Pisano, Interim CEO and Chair of the Board of Oncolytics, commented, "We are appreciative of the thoughtful dialog with the FDA and are pleased to have reached an important regulatory milestone that provides a clear path forward for pelareorep's advancement towards registration in HR+/HER2- mBC. Looking ahead, initiating a registration-enabling trial has become a major corporate objective, and in parallel, we remain on track to report survival data from the BRACELET-1 study in HR+/HER2- mBC in the second half of the year. We believe these data will further bolster our compelling data package and underscores the therapeutic potential of pelareorep. We remain committed to improving the standard of care and addressing the high unmet medical needs of these patients." CONTINUED… Read this and more news for Oncolytics Biotech at: In other industry developments and happenings in the market this week include: GSK plc (NYSE: GSK), a global biopharma company, recently released positive results from an interim analysis of the DREAMM-8 phase III head-to-head trial evaluating belantamab mafodotin, in combination with pomalidomide plus dexamethasone (PomDex), versus a standard of care, bortezomib plus PomDex, as a second line and later treatment for relapsed or refractory multiple myeloma. As per the release, the drug combination reduced the risk of disease progression or death by nearly 50% versus standard of care. "With the robust results from the DREAMM-8 phase III head-to-head trial, we now have consistent data from two phase III trials supporting the potential for belantamab mafodotin combinations to redefine the treatment of multiple myeloma at or after first relapse," said Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, of GSK. "This is exciting news given the high unmet need for new and efficacious combinations once patients relapse or stop responding to initial treatments. We continue to share data and discuss our path forward with regulators." Guardant Health, Inc. (NASDAQ: GH), a leading precision oncology company, recently announced the launch of a new version of its Guardant360 TissueNext test that expanded the number of genes it identifies in a tumor tissue sample to 498. In addition to the panel expansion, Guardant has improved the test's operational workflow for a faster turnaround time. "The launch of the new Guardant360 TissueNext test is another step forward in our mission to conquer cancer with data," said Helmy Eltouky, Chairman and co-CEO of Guardant Health. "In addition to identifying guideline-recommended biomarkers, the upgraded test now provides more comprehensive gene coverage, so oncologists can make better informed decisions about the optimal treatment strategy for their patients with advanced cancer and help improve their outcomes." Exelixis, Inc. (NASDAQ: EXEL), a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care, recently settled two patent litigations with Cipla Ltd. and Cipla USA, Inc. (collectively Cipla) in response to Cipla's Abbreviated New Drug Application (ANDA) seeking approval to market generic versions of CABOMETYX® (cabozantinib) tablets prior to the expiration of the applicable patents. Prior to the settlement earlier this year, Exelixis also announced detailed results of its Phase 3 CONTACT-02 pivotal trial evaluating the above-mentioned cabozantinib in combination with atezolizumab in metastatic castration-resistant prostate cancer at this year's ASCO GU 2024 event. As per the results, the combination reduced the risk of disease progression or death by 35%. "Given there are limited options after progression on novel hormonal therapy, we recognize the need for a regimen that can delay disease progression, that has an acceptable tolerability profile and that is widely available to patients who may not have the means or desire to travel to specialized centers for other therapies," said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. "We look forward to discussing these important results with the U.S. Food and Drug Administration, and to learning more in the next analysis of overall survival, anticipated this year." Through its recently-acquired Kite subsidiary, Gilead Sciences, Inc. (NASDAQ: GILD) recently announced results from three new analyses for Yescarta (axicabtagene ciloleucel) in relapsed/refractory (R/R) large B-cell lymphoma (LBCL), including both new clinical research and real-world evidence highlighting manufacturing and product characteristics of Yescarta, and outpatient administration of both Yescarta and Tecartus® (brexucabtagene autoleucel) at the 2024 European Hematology Association (EHA) Annual Congress, June 13-16, Madrid. "We are committed to improving survival outcomes for people living with difficult-to-treat blood cancers," said Ibrahim Elhoussieny, Vice President, Medical Affairs, of Kite. "These new data support the potential benefit of utilizing Yescarta in earlier lines of treatment, both in terms of manufacturing success and product characteristics. Additional data support the safety and feasibility of administering CAR T-cell therapy in the outpatient setting. These data contribute to the body of evidence for efficient utilization and delivery of Yescarta and Tecartus and further support our ambition for patients." Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group

Phase 3Clinical ResultImmunotherapy

18 Jun 2024

·www.prnewswire.com

Live from EHA 2024 | Ascentage Pharma Releases Updated Data of Lisaftoclax in Patients with R/R MM and AL Amyloidosis Highlighting Marked Improvement in ORR

SUZHOU, China and ROCKVILLE, Md., June 18, 2024 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that it has released updated data of the Bcl-2 inhibitor lisaftoclax (APG-2575), one of the company's key drug candidates, combined with novel therapeutic regimens in patients with relapsed/refractory (R/R) multiple myeloma (MM) or immunoglobulin light-chain (AL) amyloidosis, in a poster presentation at the 2024 European Hematology Association Hybrid Congress (EHA 2024), taking place in Madrid, Spain. Building on results from the study released for the first time at the 2023 American Society of Hematology Annual Meeting, the updated data presented at EHA 2024 continued to show impressive efficacy and favorable safety of lisaftoclax-based combinations, particularly the combination with pomalidomide and dexamethasone in R/R MM. Moreover, the study reported an incidence of Grade 3 or higher treatment-related neutropenia of 14.3%, which underscored the regimens' potential in offering patients a safe new treatment option. Prof. Sikander Ailawadhi, MD, from Mayo Clinic and the principal investigator of this study, commented, "This is a study of lisaftoclax combined with novel therapeutic regimens in patients with R/R MM or AL amyloidosis. From the primary analysis, it demonstrated that lisaftoclax + pomalidomide in R/R MM could achieve ≥very good partial response (VGPR) rate of 33.3%, and higher VGPR along with increasing lisaftoclax dosage. Moreover, lisaftoclax based therapy in both R/R MM and amyloidosis is very well tolerated with Grade 3/4 neutropenia of 14.3%. This convincing data could provide an alternative treatment option to patients with MM and amyloidosis." "It is our pleasure to release the updated data of lisaftoclax in patients with R/R MM or AL amyloidosis at this year's EHA Hybrid Congress," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "These data underscore the outstanding safety and efficacy profiles of the combination therapies, once again demonstrating these regimens' global best-in-class potential. We will actively advance this clinical development program to bring patients a safe and effective new treatment option as soon as possible." The EHA Hybrid Congress is the largest gathering of the hematology field in Europe. It showcases the most cutting-edge research and state-of-the-art innovative therapies, attracting over 10,000 clinical experts and researchers from more than 100 countries every year. This year, in addition to the latest data of lisaftoclax, Ascentage Pharma also released those of the third-generation BCR-ABL1 inhibitor olverembatinib (HQP1351) and the EED inhibitor APG-5918. Highlights of the data on lisaftoclax presented at EHA 2024 are as follows: Lisaftoclax (APG-2575) Combined with Novel Therapeutic Regimens in Patients (Pts) with Relapsed or Refractory (R/R) Multiple Myeloma (MM) or Immunoglobulin Light-Chain (AL) Amyloidosis Abstract#: P917 Presentation Type: Poster presentation Topic: Myeloma and other monoclonal gammopathies – Clinical Date & Time: Friday June 14, 2024, 18:00 - 19:00 CEST Presenting Author: Prof. Sikander Ailawadhi, Mayo Clinic Florida Highlights: Background: R/R MM is incurable, with virtually inevitable relapse without appropriate therapeutic intervention. AL amyloidosis is a rare disease that may cause serious organ damage or death. Lisaftoclax is a novel, potent, selective BCL-2 inhibitor with clinical benefits in hematologic malignancies and solid tumors and a low reported incidence of adverse events (AEs). Introduction: The aim of this multicenter study was to evaluate the safety and efficacy of lisaftoclax combined with pomalidomide and dexamethasone (Arms A and C) or daratumumab, lenalidomide, and dexamethasone (Arm B) in patients with R/R MM (Arms A and B) or R/R AL amyloidosis (Arm C). Patient enrollment and methods: Patients with an Eastern Cooperative Oncology Group (ECOG) performance status≤2 were administered lisaftoclax daily in repeated 28-day cycles. Pomalidomide, daratumumab, and lenalidomide were administered per label use. Dexamethasone was administered at 40 mg/day, and patients aged>75 were administered at the reduced dose of 20 mg/day. As of January 25, 2024, 44 patients that included 36 patients with R/R MM and 8 patients with R/R AL amyloidosis were enrolled in the 3 arms of the study (Arms A, B, and C) to receive lisaftoclax at various doses. The median (range) age of patients was 70.5 (24-88) years, 68.2% were male, and 65.9% were older than 65 years. The median (range) number of lines of prior therapies was 3 (1-19), median (range) time from diagnosis to the first dose of study drug was 5.5 (1-29) years, and median (range) number of treatment cycles was 4 (1-26). Efficacy results: In Arm A, 27 patients with R/R MM were efficacy evaluable. Among them, 10 had partial response (PR), 7 had very good PR (VGPR), and 2 had complete response (CR). The overall response rate (ORR [PR+VGPR+CR]) was 70.4%. In Arm B, 2 patients with R/R MM achieved CR. In Arm C, 7 patients with R/R AL amyloidosis were efficacy evaluable, and the ORR was 85.7% (4 VGPRs, 2 CR). Safety results: Of the 42 patients included in safety analysis, 10 patients experienced Grade ≥3 treatment-related adverse events (TRAEs), including neutropenia (14.3%), febrile neutropenia (2.4%). 3 patients experienced serious TRAEs that included febrile neutropenia, acute kidney injury, and diarrhea with electrolyte imbalance (1 each). A total of 24 patients discontinued treatment because of disease progression (n=15), treatment-emergent AE (TEAE, n=3), nonadherence (n=1), or investigator/patient decision (n=5). Conclusions: Lisaftoclax plus novel therapeutic regimens was well tolerated and demonstrated preliminary antitumor activity in patients with either R/R MM or AL amyloidosis. *Lisaftoclax is an investigational drug that has not been approved in any country and region. About Ascentage Pharma Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK. Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of 9 clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials, including 5 global registrational phase III studies, in the US, Australia, Europe, and China. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five Major New Drug Projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases. Olverembatinib, the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company's first approved product, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China 2022 National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company's investigational drug candidates. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships with numerous renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, MSD, and AstraZeneca. The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients. Forward-Looking Statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. SOURCE Ascentage Pharma

Orphan DrugClinical ResultFast TrackBreakthrough TherapyASH

17 Jun 2024

·www.fiercepharma.com

From market withdrawal back to £3B peak sales: GSK dreams big for myeloma ADC Blenrep

In second-line multiple myeloma, GSK’s goal is to replace Johnson & Johnson’s Darzalex with Blenrep, GSK Chief Commercial Officer Luke Miels said. Two back-to-back pivotal trial wins have rekindled hopes at GSK that once-failed multiple myeloma drug Blenrep could reach more than 3 billion pounds sterling in peak sales after all. GSK refloated that 3 billion-pound ($3.8 billion) figure during an oncology-focused investor event Monday. For an old calculation that had previously been thrown out following a market withdrawal in November 2022, GSK has maintained enough caution to still leave the non-risk-adjusted number out of its current group guidance. The 3 billion figure was mainly built on a potential FDA approval for Blenrep in second-line multiple myeloma, where GSK’s goal is to replace Johnson & Johnson’s Darzalex, GSK Chief Commercial Officer Luke Miels said on a separate call with reporters. In the phase 3 DREAMM-7 trial, Blenrep cut the risk of progression or death by 59% compared with Darzalex in the two meds’ respective combinations with Takeda’s Velcade and the steroid dexamethasone. It marked one of two positive second-line trials for the GSK drug. In the phase 3 DREAMM-8 study, Blenrep slashed the risk of cancer progression or death by 48% compared with Velcade in their respective combinations with Bristol Myers Squibb’s Pomalyst and dexamethasone. Miels suggested that as Darzalex, an anti-CD38 antibody, is increasingly used more in newly diagnosed patients, Blenrep, a BCMA-directed antibody-drug conjugate, could become a standard in the second-line setting. But Blenrep won’t be alone: J&J and Legend Biotech’s BCMA CAR-T Carvykti and potentially BCMA-targeted T-cell engagers such as J&J’s Tecvayli pose threats. During Monday’s press briefing, Miels once again highlighted CAR-T’s obstacle that requires these complicated therapies to be administered at a few specialized treatment centers when about 70% of myeloma patients in the U.S. are being treated in the community setting. While bispecifics can be given off the shelf outside large academic centers, patients still need to be hospitalized to monitor for potentially dangerous immune overreactions and neurologic symptoms with the drug’s current FDA-approved late-line label. Potentially fatal infections are another problem observed with the bispecifics. “I think we’ve got a very, very competitive product here that’s going to be compelling for community-based physicians—compelling for older, more frail patients,” Miels said. That distinction of an older population is important because doctors may also opt for combinations that use Amgen’s more potent proteasome inhibitor Kyprolis in younger, more fit patients. Neither CAR-T nor Blenrep has head-to-head data against Kyprolis-containing regimens. Blenrep has its own problem, notably eye toxicities. But Miels said the ocular problems are reversible and don’t lead to blindness. During the investor presentation, Evangelos Terpos, M.D., Ph.D., from the National & Kapodistrian University of Athens and principal investigator of the DREAMM-8 trial, noted that dose modifications in patients with ocular adverse events could still help patients achieve desirable outcomes while keeping treatment discontinuation rates low. “We’ve learned how to dose it in a way that we can reduce those risks for the patients and significantly reduce the number of patients that have to stop the drug,” Miels said on the press call, pointing to about 4% of patients in Blenrep’s phase 3 programs who had to discontinue treatment because of eye side effects. While the 3 billion-pound value is mostly pegged to the second-line setting, GSK is exploring the potential to move Blenrep into the first line. There, “we’ve just got to work out the dose and the design,” Miels said. When GSK made the decision to pull Blenrep off the market in late 2022 because of a phase 3 monotherapy flop, the British drugmaker decided not to downsize its 75-people-strong U.S. hematology commercial team. “Essentially, the calculated judgment we took at the time was that there would be a pathway back for Blenrep, because Blenrep is a very potent drug—it was really a question of dosing,” Miels said. The team is currently detailing GSK’s anemic myelofibrosis drug Ojjaara and are being trained around Blenrep. Miels said GSK will probably expand the sales team and the medical affairs team for Blenrep. For Ojjaara, GSK has pegged the JAK inhibitor to reach more than 1 billion pounds ($1.27 billion) in peak-year sales. The company also expects more than 2 billion pounds ($2.54 billion) at peak for the PD-1 inhibitor Jemperli, plus another 2 billion pounds for a package of candidates centered on the TIGIT antibody belrestotug. Blockbuster potential was also assigned to the B7-H3 and B7-H4 ADCs that GSK recently in-licensed from China’s Hansoh Pharma.

Phase 3Clinical ResultADC

100 Deals associated with Pomalidomide

External Link

KEGG	Wiki	ATC	Drug Bank
D08976	Pomalidomide	L04AX06	DB08910

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Kaposi Sarcoma	US	Bristol Myers Squibb Co.	14 May 2020
Multiple Myeloma	US	Bristol Myers Squibb Co.	08 Feb 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Relapse multiple myeloma	NDA/BLA	EU	Viatris Ltd. (New Zealand)	14 Dec 2023
Plasma cell myeloma refractory	Phase 3	AU	Celgene Corp.	01 Mar 2011
Plasma cell myeloma refractory	Phase 3	BE	Celgene Corp.	01 Mar 2011
Plasma cell myeloma refractory	Phase 3	CA	Celgene Corp.	01 Mar 2011
Plasma cell myeloma refractory	Phase 3	CZ	Celgene Corp.	01 Mar 2011
Plasma cell myeloma refractory	Phase 3	DK	Celgene Corp.	01 Mar 2011
Plasma cell myeloma refractory	Phase 3	FR	Celgene Corp.	01 Mar 2011
Plasma cell myeloma refractory	Phase 3	DE	Celgene Corp.	01 Mar 2011
Plasma cell myeloma refractory	Phase 3	GR	Celgene Corp.	01 Mar 2011
Plasma cell myeloma refractory	Phase 3	IT	Celgene Corp.	01 Mar 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03683277 (IFM2014-01, EHA2024) Manual	Phase 2	Multiple Myeloma	26	IXAZOMIB+POMALIDOMIDE+DEXAMETHASONE	rivhwyyzzp(hfmvvqiume) = engglpnprc tbjwhaehip (mgmsaxrlcg, 4.4 - NR) View more	Positive	14 May 2024
EHA2024	Not Applicable	Hematopoietic stem cell transplantation Maintenance	24	Pomalidomide 1mg/day	zumebtfgfg(satnkkbvbu) = zddwmmhwqs gbhmhdxjiu (aflmegygge ) View more	Positive	14 May 2024
NCT03715478 (ALGONQUIN, Pubmed \| Nat Med)	Phase 1/2	Multiple Myeloma lenalidomide refractory \| proteosome inhibitor exposed	87	Belantamab mafodotin	iuelooydet(ohomjhytah) = 71.1% thmdkuefsm (bdwkjnsznc ) View more	-	04 Jan 2024
NCT03910244 (PATH-HHT, ASH2023) Manual	Phase 2	Telangiectasia, Hereditary Hemorrhagic	144	Pomalidomide	olqexkafrs(sbcgtpfgyf) = bpcnfhblxu furqferaqu (yjgogohkbg, -2.24 to -1.44) View more	Positive	12 Dec 2023
NCT03910244 (PATH-HHT, ASH2023) Manual	Phase 2	Telangiectasia, Hereditary Hemorrhagic	144	Placebo	olqexkafrs(sbcgtpfgyf) = xfqkafkgum furqferaqu (yjgogohkbg, -1.39 to -0.39) View more	Positive	12 Dec 2023
NCT03590652 (ASH2023)	Phase 2	Relapse multiple myeloma	46	Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone (DIPD)	usopzghoww(hzgalghqpr) = ppkojfnjao hawczirjmj (wxosonnybq ) View more	-	11 Dec 2023
ASH2023	Not Applicable	Relapse multiple myeloma	187	Daratumumab, Pomalidomide and Dexamethasone	ekcbvybdrj(bjmpxcbxaf) = encfzmybin lbmlkpyzlx (ohbdkbarng ) View more	-	10 Dec 2023
ASH2023	Not Applicable	Relapse multiple myeloma	187	Daratumumab, Carfilzomib and Dexamethasone	ekcbvybdrj(bjmpxcbxaf) = ucqvbflngb lbmlkpyzlx (ohbdkbarng ) View more	-	10 Dec 2023
NCT03732703 (MyDRUG, ASH2023)	Phase 1/2	Multiple Myeloma	17	Selinexor	lcgbdvxnrm(jgsfxvftim) = wuwafugqfw qporlwxpce (vxqqxzuqtz ) View more	Positive	10 Dec 2023
NCT04835129 (IMPEDE-NCT04835129, ASH2023)	Phase 2	Multiple Myeloma	15	Isatuximab, Elotuzumab, Pomalidomide, and Dexamethasone	ggdnosfepf(egezvpctxb) = hacntukpqr gmpaffxdpa (bmeuracbjf ) View more	-	10 Dec 2023
iPod-790 (ASH2023)	Phase 2	Relapse multiple myeloma Third line	60	Ixazomib, Pomalidomide, and Dexamethasone Combination	vsidisdfke(ethavcoxnd) = ckhfdumwhi zaiyxfbahk (quzyzybmgp ) View more	-	09 Dec 2023
NCT02004275 (ALLIANCE A061202, CTgov)	Phase 1/2	Relapse multiple myeloma	118	pomalidomide+dexamethasone (Arm I (Pomalidomide, Dexamethasone))	pcwzuksgyx(ngrsrqzzpm) = ywxknvfhme aspsgqqveh (xaqpkcjqyk, djqupcmtvf - rgltrtzilf) View more	-	01 Dec 2023
NCT02004275 (ALLIANCE A061202, CTgov)	Phase 1/2	Relapse multiple myeloma	118	ixazomib+pomalidomide+dexamethasone (Arm II (Pomalidomide, Dexamethasone, Ixazomib))	pcwzuksgyx(ngrsrqzzpm) = ejindmqqcx aspsgqqveh (xaqpkcjqyk, hstghegwsl - reudlvttuc) View more	-	01 Dec 2023

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