Cellectar Biosciences’ Iopofosine I 131 Exceeds Primary Endpoint in Waldenstrom’s Macroglobulinemia Pivotal Study with 78% of Major Response Patients Remaining Progression Free at 18 Months
Cellectar Biosciences (NASDAQ: CLRB) announced positive results from its CLOVER WaM pivotal study evaluating iopofosine I 131 for relapsed/refractory Waldenstrom's macroglobulinemia (WM). The study achieved an 80% overall response rate and a 56.4% major response rate, exceeding the primary endpoint of 20%. Notably, 78% of major response patients remained progression-free at 18 months.
The study included heavily pretreated patients, with 27% refractory to all available therapies and 40% dual-class refractory. Iopofosine I 131 demonstrated efficacy across challenging subgroups and was well-tolerated. Cellectar plans to submit an NDA in Q4 2024, seeking priority review.
Cellectar Biosciences (NASDAQ: CLRB) ha annunciato risultati positivi dal suo studio pivotale CLOVER WaM che valuta iopofosine I 131 per la macroglobulinemia di Waldenstrom in fase di ricaduta/resistenza ai trattamenti. Lo studio ha raggiunto un 80% di tasso di risposta complessiva e un 56.4% di tasso di risposta maggiore, superando l'obiettivo primario del 20%. In particolare, il 78% dei pazienti con risposta maggiore è rimasto privo di progressione a 18 mesi.
Lo studio ha incluso pazienti fortemente pretrattati, con il 27% refrattario a tutte le terapie disponibili e il 40% refrattario a due classi di trattamento. Iopofosine I 131 ha dimostrato efficacia anche in sottogruppi difficili e ha mostrato una buona tollerabilità. Cellectar prevede di presentare una domanda NDA nel quarto trimestre del 2024, richiedendo una revisione prioritaria.
Cellectar Biosciences (NASDAQ: CLRB) anunció resultados positivos de su estudio pivotal CLOVER WaM que evalúa iopofosine I 131 para la macroglobulinemia de Waldenstrom en recaída/resistente a tratamiento. El estudio logró una tasa de respuesta global del 80% y una tasa de respuesta mayor del 56.4%, superando el objetivo primario del 20%. Notablemente, el 78% de los pacientes con respuesta mayor permanecieron sin progresión a los 18 meses.
El estudio incluyó pacientes con un alto grado de tratamiento previo, con un 27% refractarios a todas las terapias disponibles y un 40% refractarios a dos clases de tratamiento. Iopofosine I 131 mostró eficacia en subgrupos desafiantes y fue bien tolerado. Cellectar planea presentar una NDA en el cuarto trimestre de 2024, solicitando revisión prioritaria.
Cellectar Biosciences (NASDAQ: CLRB)는 재발/저항성 월덴스트롬 매크로글로불린혈증(WM)을 평가하는 CLOVER WaM 주요 연구에서 긍정적인 결과를 발표했습니다. 이 연구는 80%의 전체 응답률과 56.4%의 주요 응답률을 달성하여 20%의 주요 목표를 초과했습니다. 특히, 주요 응답 환자의 78%가 18개월 동안 진행 없는 상태를 유지했습니다.
연구에는 치료를 많이 받은 환자가 포함되었으며, 그 중 27%는 사용 가능한 모든 치료에 저항성이 있었고 40%는 이중 클래스 저항성이었습니다. Iopofosine I 131은 도전적인 하위 그룹에서도 효능을 입증했으며 내약성이 좋았습니다. Cellectar는 2024년 4분기에 NDA를 제출할 계획이며, 우선 검토를 요청하고 있습니다.
Cellectar Biosciences (NASDAQ: CLRB) a annoncé des résultats positifs de son étude pivotale CLOVER WaM évaluant l'iopofosine I 131 pour la macroglobulinémie de Waldenström en rechute/résistante. L'étude a atteint un taux de réponse global de 80% et un taux de réponse majeur de 56,4%, dépassant l'objectif primaire de 20%. Notamment, 78% des patients ayant obtenu une réponse majeure sont restés sans progression à 18 mois.
L'étude a inclus des patients ayant subi de nombreux traitements, avec 27% refractaires à toutes les thérapies disponibles et 40% refractaires en double classe. L'iopofosine I 131 a démontré son efficacité dans des sous-groupes difficiles et a été bien tolérée. Cellectar prévoit de soumettre une NDA au quatrième trimestre de 2024, demandant un examen prioritaire.
Cellectar Biosciences (NASDAQ: CLRB) hat positive Ergebnisse aus seiner entscheidenden CLOVER WaM-Studie zur Bewertung von Iopofosine I 131 bei rezidivierter/resistenter Waldenström-Makroglobulinämie (WM) bekannt gegeben. Die Studie erreichte eine Gesamtansprechrate von 80% und eine Hauptansprechrate von 56,4%, was das primäre Ziel von 20% übertraf. Bemerkenswert ist, dass 78% der Patienten mit Hauptansprechen nach 18 Monaten progressionsfrei blieben.
Die Studie umfasste stark vorbehandelte Patienten, von denen 27% gegenüber allen verfügbaren Therapien refraktär waren und 40% doppelt-klassen refraktär. Iopofosine I 131 zeigte in herausfordernden Untergruppen Wirksamkeit und wurde gut vertragen. Cellectar plant, im vierten Quartal 2024 einen NDA-Antrag einzureichen und eine vorrangige Prüfung anzufordern.
- 80% overall response rate achieved, significantly exceeding expectations
- 56.4% major response rate, surpassing the 20% primary endpoint
- 98.2% disease control rate in heavily pretreated patients
- 78% of major response patients remained progression-free at 18 months
- Efficacy demonstrated across difficult-to-treat subgroups
- Well-tolerated safety profile with manageable adverse events
- NDA submission planned for Q4 2024 with potential priority review
- Iopofosine I 131 is still an investigational agent, not yet approved for use
Impact on Clinical Outcomes: The reported 80% overall response rate (ORR) and 56.4% major response rate (MRR) in the CLOVER WaM pivotal study for iopofosine I 131 is a significant clinical milestone. These results considerably exceed the primary endpoint of a 20% MRR, highlighting the drug's efficacy in treating relapsed/refractory Waldenstrom’s macroglobulinemia (WM). Additionally, the 98.2% disease control rate in heavily pretreated patients, including those refractory to all available therapies, indicates a promising therapeutic option for a patient population with limited alternatives. This level of response in such a difficult-to-treat cohort suggests that iopofosine I 131 could potentially fill a significant unmet need in the WM treatment landscape.
Durability of Response: The secondary endpoints of disease control rate and duration of response (DoR) showed that 78% of major response patients remained progression-free at 18 months. This durability is critical as it means less frequent treatments and potentially lower overall healthcare costs for these patients. The absence of severe adverse effects, particularly those related to cardiovascular, renal, or liver functions, further underscores the potential of iopofosine I 131 as a safer treatment compared to existing therapies.
Clinical Relevance: The positive clinical outcomes observed in the CLOVER WaM study for iopofosine I 131 are highly notable. The potential for this drug to become a first-in-class radiotherapeutic is particularly exciting given the limited options for relapsed/refractory WM patients. The lack of non-hematologic toxicities positions it favorably compared to other intensive cancer therapies which often come with severe side effects. The responses across challenging disease subgroups, including MYD88-wt and P53-mutated patients, are particularly encouraging, as these subgroups often have poorer outcomes with existing treatments.
Future Implications: Should the FDA approve iopofosine I 131 following the anticipated NDA submission, this drug could redefine the treatment paradigm for WM. Its ability to provide deep and durable responses with a high disease control rate in a heavily pretreated population could make it the new standard-of-care for those who have exhausted other treatment options. This would not only improve patient outcomes but also offer a new hope for those in advanced stages of the disease.
Market Impact: The positive results from the CLOVER WaM study are likely to have a substantial impact on Cellectar Biosciences' stock value. The 80% ORR and 56.4% MRR far exceed the primary endpoint and suggest that iopofosine I 131 could become a significant revenue driver if approved. The potential submission of the NDA in the fourth quarter of 2024, along with the request for priority review, implies that the company could see regulatory approval within a six-month period. This rapid timeline could accelerate market entry and capture a substantial market share in the WM treatment space.
Investor Confidence: The study's high disease control rate of 98.2% and favorable safety profile will likely boost investor confidence in the drug's commercial viability. The absence of serious adverse effects commonly associated with other cancer treatments positions iopofosine I 131 as a potentially safer alternative, which could broaden its market appeal. Moreover, the company's clear strategy to ensure the drug's availability to patients indicates strong management foresight and commitment to addressing unmet medical needs.
56.4% major response rate exceeded20% primary endpoint98.2% disease control rate achieved in heavily pretreated patients- Responses shown in difficult-to-treat, high-needs patient populations with approximately
27% of patients refractory to all available therapies and40% dual-class refractory (BTKi and rituximab)
FLORHAM PARK, N.J., July 23, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced positive results from its CLOVER WaM pivotal study evaluating iopofosine I 131, a potential first-in-class, targeted radiotherapeutic candidate for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia (WM) patients that received at least two prior lines of therapy, including Bruton tyrosine kinase inhibitors (BTKi’s). CLOVER WaM is the first and largest WM study to date in a highly refractory patient population, including patients who are refractory to all available treatment categories.
As of May 31, 2024, results in the CLOVER WaM study (NCT02952508) had an overall response rate (ORR) of
“Treatment options for relapsed or refractory WM patients are limited with a critical need for new therapies with novel mechanisms of action. Currently, only about
Secondary endpoints of disease control rate (
“The outcomes observed in this study continue to far exceed expectations and provide evidence of the potential for iopofosine in a broad range of WM patients, including difficult-to-treat subgroups. We believe with these results that iopofosine I 131 has the potential to become the standard-of-care therapy for relapsed/refractory patients,” said James Caruso, president and CEO of Cellectar. “It is our commitment to ensure that iopofosine will be made available to patients awaiting a meaningful new treatment option. To this end, we plan to submit our NDA in the fourth quarter of 2024 and will be seeking priority review, which provides an estimated six-month regulatory review period.”
Iopofosine I 131 was well tolerated and its toxicity profile was consistent with the company's previously reported safety data. Importantly, and unlike other cancer therapies, patients on iopofosine did not experience any cardiovascular, renal, or liver toxicities, and no peripheral neuropathy or significant bleeding. The safety profile was consistent with selective targeting of tumor sites with clinically negligible off-target effect outside the hematologic system. The most commonly reported treatment emergent adverse events were hematologic in nature (thrombocytopenia, neutropenia and anemia) and were predictable and manageable. All patients recovered from cytopenias within a few weeks post nadir.
*Iopofosine I 131 is an investigational agent and has not been approved for use in any country, for any indication.
Conference Call & Webcast
The company will host an event on July 24, 2024, at 8:00 a.m., EDT, to provide a comprehensive overview of the CLOVER WaM study data, the current WM treatment landscape, unmet needs for patients with this disease, and opportunities to improve patient outcomes.
The event will feature both company leadership and key investigators. Details are as follows:
Conference Call Details
Date: July 24, 2024
Time: 8:00 a.m. EDT/ 5:00 a.m. PDT
Dial-in number: 1-800-717-1738
Webcast link: click HERE
A replay of the conference call will be available on the Events section of the company’s investor relations website.
About Waldenstrom’s Macroglobulinemia
WM is a B-cell malignancy characterized by bone marrow infiltration of clonal lymphoplasmacytic cells that produce a monoclonal immunoglobulin M (IgM) that remains incurable with available treatments. The prevalence in the US is approximately 26,000 with 1,500-1,900 patients being diagnosed annually. Approximately 11,500 patients require treatment in the relapsed or refractory setting and there are an estimated 4,700 patients requiring 3rd line or greater therapy. There are approximately 1,000 patients that have exhausted all current treatment options by 3rd line because they are ineligible or intolerant to those existing therapies. Therefore, the total addressable market for 3rd line or greater therapy is approximately 5,700 patients. There are no FDA approved treatment options for patients progressing on BTKi therapy. BTKi therapies do not demonstrate complete response rates and require continuous treatment. Approximately
About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects.
The company’s product pipeline includes lead asset iopofosine I 131, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.
For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: Twitter, LinkedIn, and Facebook.
Forward-Looking Statement Disclaimer
This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes including our expectations regarding the CLOVER WaM pivotal trial. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the disruptions at our sole source supplier of iopofosine, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA’s review process and view of our data, and other government regulation, our ability to maintain orphan drug designation in the United States for iopofosine, the volatile market for priority review vouchers, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2023, and our Form 10-Q for the quarter ended March 31, 2024. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.
Contacts
MEDIA:
Claire LaCagnina
Bliss Bio Health
315-765-1462
clacagnina@blissbiohealth.com
INVESTORS:
Chad Kolean
Chief Financial Officer
investors@cellectar.com
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