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Medscape
a day ago
- Health
- Medscape
Cilta-cel CAR T: Myeloma ‘Cure' and Conjecture
Not a day goes by in clinic without a patient asking about the recent New York Times article on multiple myeloma: "Doc, is there really a cure now? I want this treatment." The article was boldly titled "From No Hope to a Potential Cure for a Deadly Blood Cancer." But did we truly leap from "no hope" to "potential cure"? In this commentary, I explore what the article got right, where caution is warranted, and how I think about the notion of a cure for myeloma. Manni Mohyuddin, MD Historically, patients with heavily pretreated, relapsed myeloma had grim prognoses, often with less than a year of survival. The arrival of BCMA- and GPRC5D-directed therapies has rewritten expectations for this population. Cilta-cel, a BCMA-targeted chimeric antigen receptor (CAR) T-cell product, is a standout. A recent long-term follow-up study in Journal of Clinical Oncology (JCO) reported that one third (32 of 97) of patients remained progression-free 5 years after a single cilta-cel infusion. It's a remarkable outcome, one worthy of celebration, yet we must interpret these results with care. Of the 113 enrolled patients, only 97 received cilta-cel, and only the outcomes of those 97 are described, with the unfortunate ones whose disease progressed before cilta-cel infusion omitted from this narrative. Patients with rapidly progressing or unstable disease often don't make it to CAR T — a natural selection bias. Moreover, heavy censoring at the tail end of the Kaplan-Meier survival curve, a statistical method used to track patient outcomes over time, and where many patients drop out or are lost to follow-up, introduces uncertainty about what the results will be with even longer follow-up. A real-world study of cilta-cel showed 12-month progression-free survival (PFS) at just 68%, making it unlikely that we will see such outcomes with 5 years of follow-up in the real world, and highlighting the gap between clinical trial efficacy and real-world effectiveness. This discrepancy is not new. The MAIA study reported a median PFS beyond 5 years for newly diagnosed patients treated with daratumumab, lenalidomide, and dexamethasone (DRd). Yet, in real-world cohorts, PFS is closer to 2-3 years. Differences in censoring, progression definitions, and patient selection drive this gap. Given these dynamics, a 30% five-year PFS in real-world practice for this patient population seems unlikely. While some patients, perhaps 10%-15%, may experience truly durable responses, presenting the trial's cure fraction as broadly achievable would be misleading. The word "cure" featured prominently in both the JCO publication and the New York Times article. However, the most recent definition of cure in myeloma includes sustained measurable residual disease (MRD) negativity off all therapy for at least 5 years. When asked, patients have clearly indicated that they do not consider themselves cured while still on treatment (as is often the case in myeloma), no matter what the disease response is. I celebrate this trial for many reasons, but one important one is that it gave patients such valuable time off from treatment. However, during long-term follow-up of this trial, MRD negativity was not routinely assessed. At one center, 12 patients were evaluated serially and found to be MRD negative. But this was a post hoc analysis, and data from other centers weren't reported. Given the nuanced ways that relapse is defined in myeloma (with markers having to be above a certain threshold), we must be cautious in declaring these patients cured. Some of them may already have signs of relapse that has not yet reached a certain threshold to call it as progression. I also must admit to feeling distressed that a top-notch journal allowed the authors to make such bold statements based on post hoc analysis from a single center. Such post hoc data mining — where researchers look for patterns after seeing the results — carries a high risk for false discoveries and should not support definitive claims about cure. The article implies that these long-term remissions and cure are unprecedented. That's simply not true. Long-term follow-up from studies using intensive upfront therapy have shown that many patients — especially those with standard-risk disease — achieve long remissions, are off treatment, and remain alive for years. To claim that we've gone from "no hope" to "potential cure" neglects this important context. Myeloma had seen sustained, incremental progress across multiple drug classes well before cilta-cel emerged. Cilta-cel is a powerful therapy, but it is not without risk — something the article omits. It has horrendous, unpredictable toxicities that were not mentioned in the New York Times article. These include secondary cancers, a horrible diarrhea due to immune-mediated gut damage, and often irreversible neurologic damage. Thankfully, these are not experienced by the majority of patients, but we are imperfect at predicting to whom they do happen, and many of these toxicities are currently permanent. Despite these critiques, I view the New York Times story as a net positive. It raises awareness about the progress we've made and offers patients hope. I do believe we are curing some patients with myeloma, and cilta-cel is part of that story. However, the 30% cure rate cited in the article is probably an illusion among such a heavily pretreated population (although I am hopeful for an even higher cure rate in the newly diagnosed setting). I envision a future with safer therapies that more reliably increase the cure fraction. And while I appreciate how this article shined a spotlight on myeloma, I hope that future media coverage embraces the nuance that this disease — and its patients — deserve.
Business Standard
11-07-2025
- Business
- Business Standard
Glenmark Pharma soars on AbbVie licensing deal for cancer therapy ISB 2001
Glenmark Pharmaceuticals hit an upper limit of 10% to a record high of Rs 2095.65 after its subsidiary Ichnos Glenmark Innovation (IGI) unveiled a global commercialization strategy for its lead investigational oncology asset, ISB 2001. The announcement follows a major licensing agreement with U.S. biopharma giant AbbVie. Under the terms of the agreement, IGI will collaborate with AbbVie to develop, manufacture, and commercialize ISB 2001, a first-in-class trispecific T-cell engager designed to treat multiple myeloma. AbbVie will handle development and commercialization in North America, Europe, Japan, and Greater China. Glenmark Pharmaceuticals will take charge of manufacturing and marketing the therapy in Emerging Markets, including Asia (excluding key developed markets), Latin America, the Russia/CIS region, the Middle East, Africa, Australia, New Zealand, and South Korea. ISB 2001, currently in Phase 1 clinical development, targets BCMA and CD38 on myeloma cells and CD3 on T cells. Developed using IGI's proprietary BEAT protein platform, the asset is engineered to enhance efficacy even at low antigen expression levels while aiming to improve safety over traditional bispecific antibodies. Data presented at the 2025 ASCO Annual Meeting showed promising results: a 79% overall response rate and 30% complete/stringent complete response in a heavily pretreated patient population. The therapy has also received Orphan Drug Designation (July 2023) and Fast Track Designation (May 2025) from the U.S. FDA for relapsed/refractory multiple myeloma. With this landmark deal, Glenmark is poised to strengthen its footprint in the global oncology market while expanding patient access to next-gen immunotherapies across high-need regions. "Our collaboration with AbbVie and Glenmark reflects IGI's mission to accelerate access to transformative multispecifics for patients worldwide," said Cyril Konto, M.D., President, Executive Director and CEO of IGI. "AbbVie's reach in major markets combined with Glenmark's commercial strength in Emerging Markets, creates complementary access pathways for ISB 2001, a trispecific T-cell engager with promising potential in Multiple Myeloma." "At Glenmark, we are committed to expanding access to innovative cancer treatments across Emerging Markets where unmet need and growth potential intersect," said Christoph Stoller, President Europe and Emerging Markets, Glenmark Pharmaceuticals. "The addition of ISB 2001 is a natural evolution of our oncology strategy. With our deep commercial footprint, strong regulatory capabilities, and experience in launching breakthrough assets like BRUKINSA and TEVIMBRA in India, and rights to commercialize QiNHAYO (envafolimab), a PD-L1 checkpoint inhibitor, in Emerging Markets, we are well positioned to deliver impactful treatment option for patients with difficult-to-treat cancers through ISB 2001." Headquartered in New York, IGI is a global, fully integrated clinical-stage biotechnology company focused on developing innovative biologics in oncology. Glenmark Pharmaceuticals is a research‐led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. On a consolidated basis, Glenmark Pharmaceuticals reported a net profit of Rs 4.65 crore in Q4 March 2025 as against a net loss of Rs 1,218.28 crore in Q4 March 2024. Net sales rose 6.77% year-on-year to Rs 3220.13 crore in Q4 March 2025.
Time of India
11-07-2025
- Business
- Time of India
Motilal Oswal sees 28% upside in Glenmark Pharma, hails $700 mln cancer drug deal as ‘new era' for innovation play
Motilal Oswal has reiterated a 'buy' rating on Glenmark Pharmaceuticals with a raised target price of Rs 2,430, implying a 28% upside from the current market price of Rs 1,904, as it hailed the company's recent licensing deal with AbbVie as a turning point for its innovation-led strategy. The brokerage said the agreement—executed via Glenmark's subsidiary Ichnos Glenmark Innovation (IGI)—'validates several aspects' of the company's R&D platform and unlocks substantial commercial potential. The target price revision factors in an additional net present value (NPV) of Rs 470 per share from the deal, layered on top of 27x 12-month forward earnings from Glenmark's base business. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Co-live Units Starting from 42L+ | Whitefield Sumadhura Learn More Undo 'The deal validates several aspects of GNP: a) the strength of IGI's BEAT protein platform for oncology and auto-immune diseases; b) the potential of ISB-2001 to treat relapsed/refractory multiple myeloma; and c) the commercial viability of ISB-2001 following successful clinical trials and subsequent commercialization,' the brokerage noted. IGI has entered into an exclusive global licensing agreement with U.S.-based AbbVie for ISB-2001, a first-in-class trispecific T-cell engager currently undergoing Phase 1 trials. Under the agreement, IGI will receive an upfront payment of $700 million, contingent on regulatory approvals, and is eligible for up to $1.2 billion in milestone-based payouts, along with tiered, double-digit royalties on sales. Motilal Oswal pointed out that this is one of the largest licensing transactions globally in terms of upfront payment, ranking fourth in the pharma sector. 'Oncology accounts for the majority of global licensing deals,' it said, adding that ADCs, bispecifics, and protein degraders continue to command the highest deal premiums. Live Events Financial re-rating backed by growth outlook The brokerage expects Glenmark's consolidated revenue, EBITDA, and profit after tax to grow at a compound annual rate of 11%, 17%, and 20% respectively over FY25–27. These are expected to reach Rs 163 billion, Rs 33 billion, and Rs 20 billion by FY27. 'Over the past two years, GNP has: a) reduced its financial leverage; b) improved the commercial prospects of innovative R&D c) strengthened its ANDA pipeline for the US market; and d) undertaken a strategic reset in its domestic formulation business,' Motilal Oswal said. The brokerage said it estimates a 23% earnings CAGR over the next three years, driven by 10%/7%/12%/14% growth in the domestic, US, EU, and rest-of-world segments respectively, supported by a 200-basis-point margin expansion. Motilal Oswal called ISB-2001 'scientifically superior,' citing a higher overall response rate and complete/stringent complete response rate of 30% at active doses. The drug, which co-targets BCMA and CD38 antigens in multiple myeloma, has a favourable safety profile and aims to overcome resistance observed in BCMA-only therapies. The brokerage sees strong commercial prospects ahead. 'Backed by its superior treatment profile and AbbVie's robust commercial strength, ISB-2001 holds strong potential to emerge as a blockbuster drug in the RRMM space,' Motilal Oswal said. Glenmark Pharmaceuticals' shares surged 20% on Friday, buoyed by investor optimism following the AbbVie licensing deal. The rally marks one of the sharpest single-day gains for the stock in recent years and comes as the market absorbs the implications of what Motilal Oswal terms 'a new era' for the company's innovation pipeline. Also read | Glenmark Pharma hits 10% upper circuit, scales fresh 52-week high on $700 mn cancer drug deal
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Business Standard
11-07-2025
- Business
- Business Standard
Glenmark Pharma soars 10%, hits 52-week high on cancer drug licensing deal
Glenmark Pharma share price today: Shares of Glenmark Pharma surged 10 per cent, recording a 52-week high of ₹2,094.40 on Friday, after the company's subsidiary firm, Ichnos Glenmark Innovation (IGI), inked an exclusive licensing agreement with AbbVie for the cancer drug, ISB 2001. At 09:30 AM, Glenmark Pharma shares were locked at the temporary upper limit of 10 per cent. In comparison, the Nifty50 was trading in the red territory, down by over 50 points, quoting 25,304.65. So far this calendar year, shares of the pharma company have witnessed a double-digit surge of 18.4 per cent. IGI and AbbVie Deal As per the agreement, IGI and AbbVie received rights to develop, manufacture and commercialise ISB 2001 across North America, Europe, Japan and Greater China. Whereas, Glenmark Pharmaceuticals will hold the commercialisation rights in emerging Market regions, which include the rest of Asia, Latin America, Russia, the Middle East, Africa, Australia, New Zealand and South Korea. 'Our collaboration with AbbVie and Glenmark reflects IGI's mission to accelerate access to transformative multispecificsTM for patients worldwide,' Cyril Konto, managing director and CEO of IGI, said in a company release. 'AbbVie's reach in major markets combined with Glenmark's commercial strength in Emerging Markets, creates complementary access pathways for ISB 2001, a trispecific T-cell engager with promising potential in Multiple Myeloma,' he added. IGI, a wholly owned subsidiary of Glenmark Pharma, is a global and fully integrated clinical-stage biotechnology firm. The company is specialised in developing innovative biologics in oncology. The company is currently headquartered in New York, US. About ISB 2001 In July 2023, the US FDA (Food and Drug Administration) gave ISB 2001 orphan drug status. Whereas, in May 2025, it was granted the fast-track status for treating patients with relapsed or hard-to-treat multiple myeloma. ISB 2001 is a first-of-its-kind drug that helps the immune system fight cancer by targeting proteins (BCMA and CD38) on myeloma cells and CD3 on T cells. It is currently in early Phase 1 trials for patients with advanced multiple myeloma.' Brokerage View- Motilal Oswal While the licensing deal offers Glenmark Pharma a significant commercial upside, Motilal Oswal believes the company also stands to gain from its robust pipeline. The Pharma company continues to strengthen its US generics portfolio in the respiratory and injectable segments. The brokerage firm is expecting a 23 per cent earnings compound annual growth rate (CAGR) over FY25-27 and has reiterated its 'Buy' rating on the stocks alongside a Sum-of-the-Parts (SOTP) target price of ₹2,430.
Mint
11-07-2025
- Business
- Mint
Glenmark Pharma share price hits 10% upper circuit on unit's cancer licensing deal with AbbVie
Shares of Glenmark Pharmaceuticals were locked at a 10% upper circuit in early trade on Friday, July 11, to hit a fresh all-time high of ₹ 2,094 apiece. The rally followed the company's announcement on Thursday that its innovation arm, Ichnos Glenmark Innovation (IGI), had signed an exclusive licensing agreement with AbbVie for IGI's lead investigational asset, ISB 2001 for use in oncology and autoimmune diseases, thereby adding to the U.S. firm's oncology portfolio. Under the terms of the agreement, IGI partners with AbbVie and grants exclusive rights to globally develop, manufacture, and commercialize ISB 2001 across North America, Europe, Japan, and Greater China, while Glenmark Pharmaceuticals will develop, manufacture, and lead commercialization of ISB 2001 across emerging markets, including the rest of Asia, Latin America, the Russia/CIS region, the Middle East, Africa, Australia, New Zealand, and South Korea, as per the company's exchange filing. ISB 2001 is a unique trispecific T-cell engager that targets BCMA and CD38 on myeloma cells and CD3 on T cells, and it is currently being tested in Phase 1 clinical trials for multiple myeloma that has come back or does not respond to treatment. Subject to regulatory clearance, IGI will receive an upfront payment of $700 million and is eligible to receive up to $1.225 billion in development, regulatory, and commercial milestone payments, along with tiered, double-digit royalties on net sales.
