Mevrometostat

The competition in follicular lymphoma is rapidly intensifying, with three CAR-T therapies and three bispecific antibodies now approved for relapsed or refractory patients. As both classes of treatments expand, the battle for dominance in this market is growing, with each therapy offering unique advantages in accessibility, efficacy, and safety profiles, setting the stage for a dynamic shift in treatment strategies. LAS VEGAS, Sept. 16, 2024 /PRNewswire/ -- Follicular lymphoma is a type of non-Hodgkin lymphoma (NHL) that develops from B-lymphocytes and is generally slow-growing or indolent. This subtype represents 20–30% of all NHL cases. While follicular lymphoma typically progresses slowly, there are instances where it can grow more rapidly. Treatment options for follicular lymphoma include, chemotherapy, radiation therapy, immunotherapy, stem cell transplantation, CAR T-cell therapy, and bispecific-antibodies. For those in the early stages of the disease (Ann Arbor stages I or II), treatment may involve radiation therapy alone or in combination with chemotherapy. Patients with advanced follicular lymphoma are typically treated initially with a combination of chemotherapy and anti-CD20 antibodies, a method known as chemoimmunotherapy. The most commonly used antibodies are RITUXAN (rituximab) and GAZYVA (obinutuzumab), which specifically target tumor cells associated with follicular lymphoma. In older patients who do not have organ dysfunction, treatment with rituximab alone may be an option. Other therapies like ZEVALIN (yttrium-90 ibritumomab tiuxetan), TAZVERIK (tazemetostat), REVLIMID (lenalidomide), and others are approved for the treatment of follicular lymphoma. CAR T-cell therapies are becoming increasingly significant in treating follicular lymphoma. YESCARTA, a CD19-directed genetically modified autologous T-cell therapy, became the first CAR-T to be approved for follicular lymphoma by the US FDA in March 2021. Before the approval of YESCARTA, BREYANZI was approved in February 2021 for Grade 3B follicular lymphoma that accounts for about 5-10% of all follicular lymphoma cases. Later in April 2022 it was approved by the European commission. In May 2024 BREYANZI was approved for the treatment of relapsed/refractory follicular lymphoma who have received two or more prior lines of systemic therapy and provided sustained clinical benefit with median duration of response not reached and the majority (77.1%) of responders in ongoing response at 18 months. In May 2022, Novartis announced that the European Commission approved KYMRIAH (tisagenlecleucel) for adult patients with relapsed/refractory follicular lymphoma who have undergone two or more systemic therapies. This approval represents the third indication for KYMRIAH, making it the first CAR-T cell therapy sanctioned in Europe for such patients, including those with relapsed/refractory follicular lymphoma Grades 1, 2, and 3A. Additionally, in May 2022, the US FDA granted approval for KYMRIAH for the same patient group. Currently, autologous CAR-T therapies are the only ones approved, but the emerging pipeline predominantly comprises autologous CAR-Ts alongside a growing number of allogeneic CAR-T therapies. Allogeneic CAR-T, a newer term, refers to donor-derived therapies offering several advantages over autologous treatments. These off-the-shelf therapies are readily available, eliminating the need to modify patient cells either at a central manufacturing site or at the point of care. Even though the reimbursement of CAR-T therapies represents a challenge for healthcare providers, insurers, and government agencies, they have successfully reached the majority of the markets by considering the patient pool demand. While determining the cost and reimbursement, various factors, such as pharmacoeconomic analysis and outcome-based responses, as well as the added value to society, have been evaluated. The CAR T-cell-related toxicity, such as the cytokine-release syndrome and neurotoxicity, remain important potential complications of this therapy. Second generation CAR T-cell therapies are emerging with more safety and efficacy to overcome these limitations. If these limitations have been overcome, these are going to be the potential drivers of the market. After CAR-T approval companies focused on developing alternative therapies to overcome CAR-Ts limitations. LUNSUMIO became the first bispecific antibody to get approval for adult patients with relapsed/refractory follicular lymphoma who have undergone two or more lines of systemic treatment in June 2022 in Europe. Later in December 2022, the US FDA approved it for the same indication. This was the game changing step toward a brighter future for follicular lymphoma patients. Bispecific antibodies are ready to use therapies and safer treatment options than CAR-Ts. In 2023, LUNSUMIO captured USD 55 million in revenue in the United States for follicular lymphoma. In the United States, AbbVie and Genmab's epcoritamab, marketed as EPKINLY, first gained FDA approval in May 2023 for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This was followed by its approval for follicular lymphoma in June 2024. With the recent FDA authorization for relapsed/refractory follicular lymphoma, along with expected approvals and launches in international markets, EPKINLY is poised to see revenue growth in the coming quarters. Its strong performance in treating relapsed/refractory DLBCL suggests it could achieve similar success in follicular lymphoma. LUNSUMIO now faces competition in the European market for follicular lymphoma, as on August 19, 2024, the European Commission granted approval for the expanded use of AbbVie and Genmab's bispecific antibody, TEPKINLY (epcoritamab), for treating adults with relapsed/refractory follicular lymphoma. The study showed an overall response rate of 83% and a complete response rate of 63%, with the median response duration being 21.4 months. Just after TEPKINLY approval in Europe, Regeneron's ORDSPONO (odronextamab) a CD20 x CD3 bispecific antibody approved by European Commission on August 26, 2024 for the treatment of adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory DLBCL, after two or more lines of systemic therapy. After this approval, ORDSPONO becomes the first off-the-shelf option that can be administered in the out-patient setting. In March 2024, the US FDA declined approval for odronextamab for treating follicular lymphoma and DLBCL. The agency issued two complete response letters concerning the biologics license application (BLA) for odronextamab in relapsed/refractory follicular lymphoma and DLBCL after two or more lines of systemic therapy. The denial was tied to the enrollment status of confirmatory trials assessing the drug. Importantly, there were no concerns raised about odronextamab's efficacy, safety, trial design, labeling, or manufacturing. Both EPKINLY, LUNSUMIO, and ORDSPONO are off-the-shelf therapies, offering greater accessibility compared to CD19 CAR-T treatments. These drugs will compete not only with each other but also with CAR-T therapies to secure a substantial portion of the follicular lymphoma market. Learn more about the FDA-approved follicular lymphoma drugs @ Drugs for Follicular Lymphoma Treatment A new class has also emerged for the treatment of follicular lymphoma, i.e., Bruton tyrosine kinase (BTK) inhibitors. In November 2023, BeiGene received approval from the European Commission for BRUKINSA (zanubrutinib) to treat relapsed/refractory follicular lymphoma. Later in March 2024, the US FDA approved BRUKINSA for the same indication. BRUKINSA is the first and only BTK inhibitor approved for this condition. To know more about follicular lymphoma treatment options, visit @ New Treatment for Follicular Lymphoma The follicular lymphoma pipeline is robust with so many companies working in the domain. Various potential therapies that are projected to enter during the forecast period include AbbVie's IMBRUVICA, Xynomic Pharmaceuticals' Abexinostat, Pfizer PF-06821497, Incyte's Parsaclisib, Bristol-Myers Squibb's Nivolumab, and others. Discover which therapies are expected to grab major follicular lymphoma market share @ Follicular Lymphoma Market Report IMBRUVICA (ibrutinib) is an anti-cancer medication available in various forms, including hard gelatin capsules, tablets, film-coated tablets, and oral suspension. It is being developed by AbbVie and is currently undergoing Phase III trials for follicular lymphoma. This study aims to determine if adding ibrutinib to the treatment will extend progression-free survival (PFS) compared to using rituximab alone in patients with newly diagnosed follicular lymphoma. Xynomic Pharmaceuticals is developing Abexinostat for treating follicular lymphoma. The company is currently testing this investigational drug in a Phase II clinical trial involving patients with relapsed/refractory follicular lymphoma who have received at least three prior therapies. The US FDA has granted Abexinostat fast-track designation for this use. In June 2021, Xynomic completed a short-form merger with Xu-Nuo Pharma in a "Going Private" transaction. Post-merger, Xu-Nuo Pharma will continue Xynomic's business as its main focus. Discover more about drugs for follicular lymphoma in development @ Follicular Lymphoma Clinical Trials The anticipated launch of these emerging therapies for follicular lymphoma are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the follicular lymphoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for follicular lymphoma is expected to grow from USD 1.4 billion in 2020 with a significant CAGR by 2034. This growth can be attributed to the introduction of upcoming therapies and the rise in the increasing incidence of follicular lymphoma. DelveInsight's latest published market report titled as Follicular Lymphoma Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the follicular lymphoma country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The follicular lymphoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Incident Cases of Follicular Lymphoma Risk-specific Incident Cases of Follicular Lymphoma Stage-specific Incident Cases of Follicular Lymphoma Mutation-specific Incident Cases of Follicular Lymphoma Transplant Eligible and Ineligible Patient Pool of Follicular Lymphoma Refractory/Relapsed Incident Cases of Follicular Lymphoma The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM follicular lymphoma market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis up to 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this follicular lymphoma market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the follicular lymphoma market. Also, stay abreast of the mitigating factors to improve your market position in the follicular lymphoma therapeutic space. Related Reports Follicular Lymphoma Pipeline Follicular Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key follicular lymphoma companies, including Incyte Corporation, Genmab A/S, BeiGene, Merck & Co., ADC Therapeutics, Xynomic Pharmaceuticals, Nordic Nanovector, TG Therapeutics Inc, Allogene Therapeutics, MEI Pharma, Innovent Biologics, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key Non-Hodgkin lymphoma companies, including Roche, Pfizer, Amgen, Novartis, Teva Pharmaceuticals, Genentech, ACD Therapeutics, among others. Non-Hodgkin Lymphoma Pipeline Non-Hodgkin Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Non-Hodgkin lymphoma companies, including Novartis, AstraZeneca, Genentech, BioInvent, Genmab, SystImmune, Nordic Nanovector, Pacylex Pharmaceuticals, Artiva Biotherapeutics, Inc., Chipscreen Biosciences, Ltd., Timmune Biotech Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Gilead Sciences, Acerta Pharma BV, Adagene Inc, Conjupro Biotherapeutics, Inc., Rhizen Pharmaceuticals, Juventas Cell Therapy Ltd., Incyte Corporation, HUYA Bioscience International, SecuraBio, Genor Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Antengene Therapeutics Limited, Regeneron Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Xynomic Pharmaceuticals, Inc., BioTheryX, Inc., UWELL Biopharma, Kronos Bio, Bio-Thera Solutions, Spectrum Pharmaceuticals, Inc., Aptose Biosciences Inc., Miltenyi Biomedicine GmbH, Precision BioSciences, Inc., Teneobio, Inc., TCR2 Therapeutics, IGM Biosciences, Inc, among others. Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key DLBCL companies, including AbbVie, Genmab, Merck, Roche, Xencor, Janssen, Denovo Biopharma, Calithera Biosciences IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, Debiopharm, Seagen, Takeda, AstraZeneca, Gilead Sciences, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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Pfizer’s internal calculation suggests that “on paper” more than eight cancer drugs could become blockbusters, even though the company is only publicly targeting eight for now, Suneet Varma, Pfizer Oncology’s commercial president, said. During a recent investor event dedicated to the newly expanded oncology business, Pfizer unveiled a goal to have eight blockbuster cancer drugs by 2030 but fell short of naming specific products. That contribution of blockbusters will come from each of Pfizer Oncology’s four focused therapeutic areas, Suneet Varma, the division’s commercial president, told Fierce Pharma in an interview on the sidelines of American Society of Clinical Oncology annual meeting in Chicago. The four fields are breast, genitourinary, hematology and thoracic cancers. Pfizer’s internal calculation suggests that “on paper” more than eight cancer drugs could become blockbusters, but the New York pharma decided that eight is what it can stand by now, Varma added. Pfizer is betting big on oncology with the $43 billion acquisition of antibody-drug conjugate specialist Seagen last year. The heavy investment runs in parallel with some multiyear, multi-billion-dollar cost-cutting schemes as once high-flying sales from COVID products fell back to earth. Like many Big Pharma deals, the Seagen tie up came with its own consolidation, including a round of proposed layoffs in Switzerland and scrapping of a manufacturing facility in Washington. The oncology department won’t be affected by Pfizer’s latest multiyear cost reduction, or, as Varma put it: “there’s nothing more to be done in oncology.” The unit has already finished its organizational shuffles and cost containment efforts, including as part of the integration between Pfizer and Seagen, he said. Pfizer in December made oncology a separate division within the group and named then-oncology R&D head Chris Boshoff, M.D., Ph.D., as chief oncology officer. As to whether Pfizer Oncology might expand its commercial infrastructure further, Varma said, “We’re at the scale that we think we need to be.”   Lung cancer reaching 'critical mass' Among the four focus areas, thoracic cancer, or mainly lung cancer, is currently the weakest link in Pfizer’s portfolio. But Varma argued that “lung will become its own franchise when it has that sufficient critical mass, which I think is upon us.” At the ASCO meeting a few days ago, Pfizer unveiled updated phase 3 results for the next-generation ALK inhibitor Lorbrena in newly diagnosed advanced ALK-positive non-small cell lung cancer. After five years, 60% of patients who got Lorbrena in the CROWN trial remained alive without disease progression, compared with just 8% for those who got Pfizer’s old ALK drug Xalkori. By investigators’ analysis, Lorbrena led to an 81% reduction in the risk of disease progression or death, or a 94% reduction in progression of brain metastases, over Xalkori. The progression-free survival results were compelling, and they compare well across trials with Roche’s current first-line standard of care, Alecensa, which reported a five-year overall survival rate of 62.5% in a phase 3 Xalkori head-to-head trial, Leerink Partners analysts said in a May 31 note.   Since its first-line approval in March 2021, Lorbrena hasn’t really threatened Alecensa’s leading position in the ALK space. In 2023, Alecensa brought Roche 1.5 billion ($1.7 billion) Swiss francs in sales, while Lorbrena ginned up $539 million for Pfizer. An FDA approval in April also just moved Alecensa into postsurgical treatment of early-stage cancers, whereas Pfizer currently doesn’t have any studies geared toward that indication. One problem that has stopped more doctors from using Lorbrena in the first-line setting has to do with the drug’s neuro toxicities, including such side effects as seizures, changes in cognitive functions or mood, mental status, among others.  Lorbrena’s best-in-class tumor progression results could persuade some doctors and patients to use it upfront, “although we do not expect it to rapidly become standard of care given the toxicity and tolerability profile, especially with no approved drugs to treat patients failing [Lorbrena],” the Leerink analysts noted. But Varma said Pfizer remains “very bullish” on Lorbrena. “Yes, there’s extra therapy management required,” Varma acknowledged. “But it’s worth it because years of life are being added to the patients.” “When we look at the data of people who switched [to Lorbrena], the outcomes are not as good,” Varma said. “So we believe firmly in your first chance is your best chance with Lorbrena.” Pfizer is applying to Lobrena some therapy management know-how brought over by the Seagen team, Varma noted. ADCs often come with complex side-effect profiles, and Seagen’s advice there could be helpful.   Genitourinary franchise to surpass breast cancer portfolio The addition of Seagen and its ADC portfolio also allows Pfizer to expand commercial capabilities in biologics as the pharma giant’s cancer portfolio has historically been dominated by small molecules. The Pfizer-Seagen cross-boosting goes in both ways, Varma said. Pfizer has its large scale and sophistication in commercialization. Pfizer Oncology’s commercial and medical sales team was already double the size of Seagen’s before the combination, and the large pharma company is now applying its digital and publicist tools to all Seagen products. Legacy Seagen’s Astellas-partnered bladder cancer drug Padcev is among the top 10 brands that Pfizer Oncology is granting “disproportionate attention” for investment and resources, sales force prioritization and agency assistance, Varma said. Thanks to some impressive first-line bladder cancer data in a combination with Merck & Co.’s Keytruda, Padcev has swept the oncology community off its feet. And Pfizer has put the Nectin-4 ADC’s peak sales at more than $3 billion from around $700 million last year, Varma said. The Pfizer exec has divided up the genitourinary cancer team into two franchises reporting directly to him: one for prostate cancer that’s built around Astellas-partnered blockbuster drug Xtandi, and the other for bladder and kidney cancers. “By separating prostate from bladder and having two GU teams, they get tremendous focus,” Varma said. Because of Padcev’s great commercial prospect, Pfizer sees GU as becoming the oncology unit’s largest franchise supplanting breast cancer between now and 2030 despite Xtandi’s expected U.S. patent cliff in 2027. Besides Padcev and Xtandi, Pfizer also has the PARP inhibitor Talzenna, which is approved alongside Xtandi in certain prostate cancer patients. In the pipeline, the company has the EZH2 inhibitor mevrometostat, which is being moved into phase 3 trials in prostate cancer; and the subcutaneous PD-1 inhibitor sasanlimab, which is initially being angled toward bladder cancer. In addition, the HER2 ADC, disitamab vedotin, also has FDA breakthrough therapy designation in HER2-positive advanced bladder cancer. As to breast cancer, the fall of Pfizer’s largest oncology asset, Ibrance, is already on full display ahead of a 2027 patent cliff. Sales from the CDK4/6 inhibitor dropped 7% year over year in 2023 to $4.75 billion as the first-in-class med faces intense competition from rival drugs by Novartis and Eli Lilly. Still, Varma suggested that Ibrance has reached “stabilization.” The aging product for now owns about half of the CDK4/6 market share and about a third of new patient starts, he said. Ibrance still plays a “foundational role” that allows other Pfizer franchises to grow and launch, Varma said. But he declined to offer a projection on where and when Ibrance might eventually bottom out. Down the pipeline, Pfizer has highlighted the selective CDK4 inhibitor atirmociclib, which it believes could become a next-generation backbone in HR-positive breast cancer. There’s also vepdegestrant, an estrogen receptor protein degrader. What’s more, disitamab vedotin could have a place behind AstraZeneca and Daiichi Sankyo’s much-touted ADC Enhertu in the HER2 breast cancer space. And Seagen’s former CEO David Epstein has touted that Enhertu-relapsed setting as a blockbuster opportunity as well.  Elsewhere in blood cancer, Pfizer is going toe-to-toe with Johnson & Johnson with their BCMA-directed T-cell engager for multiple myeloma. As J&J’s myeloma franchise is unrivaled for its modality breadth and commercial scale, Pfizer will face a tough fight even for a company of its size. Varma suggested that J&J’s franchise effect in myeloma won’t stop doctors from using Pfizer’s Elrexfio. And Seagen is here to help again, as Takeda-partnered Hodgkin lymphoma ADC Adcetris was the Seattle biotech’s biggest product before the merger. Despite his expressed confidence in Pfizer’s ability to reach eight cancer blockbusters by 2030, Varma again wouldn’t specify which drugs could reach that threshold. In a March note, Guggenheim analysts figured Padcev, Elrexfio, atirmociclib, vepdegestrant, mevrometostat, disitamab vedotin and sigvotatug vedotin (IB6 ADC) could make the cut.