2seventy bio Provides Update on KarMMa-9 Study and Previews Anticipated Strong Third Quarter Revenue Performance
2seventy bio and Bristol Myers Squibb have decided to discontinue enrollment in the Phase 3 KarMMa-9 study evaluating Abecma in newly diagnosed multiple myeloma patients. This decision is expected to result in over $80 million in cost savings for 2seventy bio and accelerate their path to breakeven in 2025.
The company reports positive momentum for Abecma, with expected third quarter U.S. revenue growth of approximately 30% from the second quarter revenue of $54 million. Demand, measured by new patients undergoing apheresis, is also expected to show double-digit growth compared to Q2 2024.
2seventy bio remains committed to expanding Abecma's reach to multiple myeloma patients, citing its differentiated safety profile and competitive efficacy, particularly when combined with effective bridging therapies.
2seventy bio e Bristol Myers Squibb hanno deciso di interrompere l'arruolamento nello studio Fase 3 KarMMa-9 che valuta Abecma nei pazienti con mieloma multiplo recentemente diagnosticato. Si prevede che questa decisione comporterà oltre 80 milioni di dollari in risparmi sui costi per 2seventy bio e accelererà il loro cammino verso il pareggio nel 2025.
L'azienda riporta una crescita positiva per Abecma, con una crescita dei ricavi negli Stati Uniti nel terzo trimestre di circa il 30% rispetto ai ricavi del secondo trimestre di 54 milioni di dollari. La domanda, misurata dai nuovi pazienti sottoposti ad aferesi, dovrebbe anche mostrare una crescita a doppia cifra rispetto al Q2 2024.
2seventy bio rimane impegnata ad espandere la portata di Abecma ai pazienti con mieloma multiplo, citando il suo profilo di sicurezza differenziato e l'efficacia competitiva, soprattutto quando combinato con terapie ponte efficaci.
2seventy bio y Bristol Myers Squibb han decidido interrumpir la inscripción en el estudio Fase 3 KarMMa-9 que evalúa Abecma en pacientes con mieloma múltiple recién diagnosticado. Se espera que esta decisión resulte en más de 80 millones de dólares en ahorros de costos para 2seventy bio y acelere su camino hacia el equilibrio en 2025.
La compañía informa de un impulso positivo para Abecma, con un crecimiento de ingresos esperado en EE.UU. de aproximadamente 30% en comparación con los ingresos del segundo trimestre de 54 millones de dólares. También se espera que la demanda, medida por nuevos pacientes sometidos a aferesis, muestre un crecimiento de dos cifras en comparación con el Q2 2024.
2seventy bio sigue comprometida a expandir el alcance de Abecma a pacientes con mieloma múltiple, citando su perfil de seguridad diferenciado y su eficacia competitiva, especialmente cuando se combina con terapias de puente efectivas.
2seventy bio와 Bristol Myers Squibb는 새로 진단된 다발성 골수종 환자에서 Abecma를 평가하는 3상 KarMMa-9 연구의 Enrollment를 중단하기로 결정했습니다. 이번 결정은 2seventy bio에게 8천만 달러 이상의 비용 절감을 가져오고 2025년에 손익 분기점에 도달하는 데 가속화할 것으로 예상됩니다.
회사는 Abecma에 대한 긍정적인 분위기를 보고하며, 3분기 미국 매출 성장률이 약 30%로, 2분기 매출 5천4백만 달러에 비해 증가할 것으로 예상하고 있습니다. 새로운 환자 수에 의해 측정된 수요도 2024년 2분기와 비교해 두 자릿수 이상의 성장을 보일 것으로 예상됩니다.
2seventy bio는 다발성 골수종 환자에게 Abecma의 범위를 확장하기 위해 헌신하고 있으며, 특히 효과적인 브리징 요법과 결합했을 때 차별화된 안전성 프로파일과 경쟁력 있는 효능을 인용하고 있습니다.
2seventy bio et Bristol Myers Squibb ont décidé d'interrompre l'inscription à l'étude de Phase 3 KarMMa-9 évaluant Abecma chez les patients nouvellement diagnostiqués avec un myélome multiple. Cette décision devrait permettre d'économiser plus de 80 millions de dollars pour 2seventy bio et accélérer leur chemin vers l'équilibre en 2025.
L'entreprise annonce une dynamique positive pour Abecma, avec une croissance du chiffre d'affaires prévue aux États-Unis d'environ 30% par rapport au chiffre d'affaires du deuxième trimestre de 54 millions de dollars. La demande, mesurée par le nombre de nouveaux patients subissant une aphérèse, devrait également montrer une croissance à deux chiffres par rapport au Q2 2024.
2seventy bio reste engagée à élargir l'accès à Abecma pour les patients atteints de myélome multiple, citant son profil de sécurité différencié et son efficacité compétitive, en particulier lorsqu'il est associé à des thérapies de pont efficaces.
2seventy bio und Bristol Myers Squibb haben beschlossen, die Rekrutierung in die Phase 3 KarMMa-9-Studie, die Abecma bei neu diagnostizierten Multiplen Myelom-Patienten bewertet, einzustellen. Es wird erwartet, dass diese Entscheidung für 2seventy bio zu Einsparungen von über 80 Millionen Dollar führen und ihren Weg zur Gewinnschwelle im 2025 beschleunigen wird.
Das Unternehmen berichtet von einem positiven Momentum für Abecma, mit einem erwarteten Umsatzwachstum in den USA im dritten Quartal von etwa 30% gegenüber dem Umsatz des zweiten Quartals von 54 Millionen Dollar. Die Nachfrage, gemessen an neuen Patienten, die einer Apherese unterzogen werden, wird ebenfalls voraussichtlich ein zweistelliges Wachstum im Vergleich zum Q2 2024 zeigen.
2seventy bio bleibt verpflichtet, die Reichweite von Abecma auf Patienten mit Multiplem Myelom zu erweitern und verweist auf das differenzierte Sicherheitsprofil und die Wettbewerbsfähigkeit der Wirksamkeit, insbesondere in Kombination mit effektiven Übergangstherapien.
- Expected cost savings of over $80 million for 2seventy bio
- Anticipated acceleration of path to breakeven in 2025
- Projected 30% growth in Abecma U.S. revenue for Q3 compared to Q2 ($54 million)
- Expected double-digit growth in new patient demand for Abecma in Q3
- Discontinuation of enrollment in Phase 3 KarMMa-9 study for Abecma in newly diagnosed multiple myeloma
- Reduced market opportunity due to improved treatment landscape for newly diagnosed multiple myeloma
Insights
This news is highly significant for 2seventy bio (TSVT) and its investors. The decision to discontinue the KarMMa-9 study will result in substantial cost savings of over
The anticipated
However, investors should note the early death rates in the KarMMa-3 study, which could impact future adoption. The company's commitment to focusing on high unmet need patients may limit market size but could lead to a more targeted and potentially profitable approach.
The discontinuation of the KarMMa-9 study in newly diagnosed multiple myeloma (NDMM) reflects the rapidly evolving treatment landscape. The increased use of quadruplet therapy induction, more aggressive consolidation and optimized maintenance regimens have significantly improved outcomes for NDMM patients.
Abecma's differentiated safety profile and competitive efficacy, especially when combined with effective bridging therapies, position it well in the relapsed/refractory setting. The focus on 3L+ patients aligns with areas of highest unmet need in multiple myeloma.
The double-digit growth in new patients undergoing apheresis in Q3 suggests increasing physician adoption and patient access. However, the reported early death rates in the KarMMa-3 study (
2seventy and Bristol Myers Squibb discontinue enrollment in Phase 3 KarMMa-9 study
Decision results in over
Expanded 3L+ label drives re-acceleration in Abecma
“With a greatly improved NDMM treatment landscape and following our rigorous review of the business case for the KarMMa-9 study, we have decided to discontinue enrollment in this Phase 3 study,” said Chip Baird, chief executive officer, 2seventy bio. “Abecma continues to show encouraging signs of growth with an expanded label in the third line and a differentiated safety profile. Consistent with our focus on capital allocation and creating value for all stakeholders, we anticipate this decision will conserve over
2seventy and its partner, BMS, remain committed to and strongly believe in the value that Abecma brings to patients and the important role it plays in the multiple myeloma treatment paradigm. Abecma has a differentiated safety profile and a competitive efficacy profile, particularly when combined with effective bridging therapies. The partners plan to continue expanding the reach of Abecma to as many multiple myeloma patients as possible.
Anna Truppel-Hartmann, chief medical officer, 2seventy bio, added, “Since we initiated the Phase 3 KarMMa-9 study in NDMM based on the positive data generated in a similar patient population in the KarMMa-2 cohort 2c study, the NDMM treatment landscape has improved considerably with the increasing use of quadruplet therapy induction, incorporation of more aggressive consolidation therapies, and the ongoing optimization of maintenance therapy regimens. As a result, there are considerably fewer eligible patients than when the study was first designed. We celebrate this progress in treatment options for patients and will continue to focus on serving patients with a high unmet need who will benefit most from Abecma. We would like to extend our deepest gratitude to the patients, their families, and the investigators and study staff who participated in this trial.”
Commercial Progress and Guidance
2seventy is pleased to report continued positive momentum in Abecma’s expected return to growth in the earlier line setting following the FDA’s approval in April 2024. The Company expects third quarter Abecma
2seventy bio and BMS share equally in all profits and losses related to development, manufacturing, and commercialization of Abecma in the
ABECMA
ABECMA is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED CYTOPENIA and SECONDARY HEMATOLOGICAL MALIGNANCIES
- Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
- Neurologic Toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed.
- Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities.
- Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA.
- T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA
- ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS.
Warnings and Precautions:
Early Death: In KarMMa-3, a randomized (2:1), controlled trial, a higher proportion of patients experienced death within 9 months after randomization in the ABECMA arm (45/254;
Cytokine Release Syndrome (CRS): CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA. Among patients receiving ABECMA for relapsed refractory multiple myeloma in the KarMMa and KarMMa-3 studies (N=349), CRS occurred in
The most common manifestations of CRS (greater than or equal to
Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.
Of the 349 patients who received ABECMA in clinical trials, 226 (
Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or symptoms of CRS and monitor patients for signs or symptoms of CRS for at least 4 weeks after ABECMA infusion. At the first sign of CRS, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated. Ensure that a minimum of 2 doses of tocilizumab are available prior to infusion of ABECMA. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.
Neurologic Toxicities: Neurologic toxicities, including immune-effector cell-associated neurotoxicity (ICANS), which may be severe or life-threatening, occurred concurrently with CRS, after CRS resolution, or in the absence of CRS following treatment with ABECMA.
In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, CAR T cell-associated neurotoxicity occurred in
At the safety update for KarMMa-3 study, one patient developed fatal neurotoxicity 43 days after ABECMA. In KarMMa, one patient had ongoing Grade 2 neurotoxicity at the time of death. Two patients had ongoing Grade 1 tremor at the time of data cutoff.
Cerebral edema has been associated with ABECMA in a patient in another study in multiple myeloma. Grade 3 myelitis and Grade 3 parkinsonism have occurred after treatment with ABECMA in another study in multiple myeloma.
Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or symptoms of neurologic toxicities and monitor patients for signs or symptoms of neurologic toxicities for at least 4 weeks after ABECMA infusion and treat promptly. Rule out other causes of neurologic symptoms. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. Counsel patients to seek immediate medical attention should signs or symptoms occur at any time.
Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, HLH/MAS occurred in
In KarMMa-3, one patient had Grade 5, two patients had Grade 4 and two patients had Grade 3 HLH/MAS. The patient with Grade 5 HLH/MAS also had Grade 5 candida sepsis and Grade 5 CRS. In another patient who died due to stroke, the Grade 4 HLH/MAS had resolved prior to death. Two cases of Grade 3 and one case of Grade 4 HLH/MAS had resolved.
In KarMMa, one patient treated in the 300 x 106 CAR-positive T cells dose cohort developed fatal multi-organ HLH/MAS with CRS. In another patient with fatal bronchopulmonary aspergillosis, HLH/MAS was contributory to the fatal outcome. Three cases of Grade 2 HLH/MAS resolved.
HLH/MAS is a potentially life-threatening condition with a high mortality rate if not recognized early and treated. Treatment of HLH/MAS should be administered per institutional guidelines.
ABECMA REMS: Due to the risk of CRS and neurologic toxicities, ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS. Further information is available at www.AbecmaREMS.com or contact Bristol-Myers Squibb at 1-866-340-7332.
Hypersensitivity Reactions: Allergic reactions may occur with the infusion of ABECMA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) in ABECMA.
Infections: ABECMA should not be administered to patients with active infections or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after ABECMA infusion.
In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, infections (all grades) occurred in
Monitor patients for signs and symptoms of infection before and after ABECMA infusion and treat appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to standard institutional guidelines.
Febrile neutropenia was observed in
Viral Reactivation: Cytomegalovirus (CMV) infection resulting in pneumonia and death has occurred following ABECMA administration. Monitor and treat for CMV reactivation in accordance with clinical guidelines. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against plasma cells. Perform screening for CMV, HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice.
Prolonged Cytopenias: In patients receiving ABECMA in the KarMMa and KarMMa-3 studies,
Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support according to local institutional guidelines.
Hypogammaglobulinemia: In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, hypogammaglobulinemia was reported as an adverse event in
Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in
Monitor immunoglobulin levels after treatment with ABECMA and administer IVIG for IgG <400 mg/dl. Manage appropriately per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.
Use of Live Vaccines: The safety of immunization with live viral vaccines during or after ABECMA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during ABECMA treatment, and until immune recovery following treatment with ABECMA.
Secondary Malignancies: Patients treated with ABECMA may develop secondary malignancies. In KarMMa-3, myeloid neoplasms (four cases of myelodysplastic syndrome and one case of acute myeloid leukemia) occurred in
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes.
Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol-Myers Squibb at 1‑888‑805‑4555 for reporting and to obtain instructions on collection of patient samples for testing of secondary malignancy.
Effects on Ability to Drive and Operate Machinery: Due to the potential for neurologic events, including altered mental status or seizures, patients receiving ABECMA are at risk for altered or decreased consciousness or coordination in the 8 weeks following ABECMA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.
Adverse Reactions: The most common nonlaboratory adverse reactions (incidence greater than or equal to
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.
About Bristol Myers Squibb and 2seventy bio
Abecma is being jointly developed and commercialized in the
About 2seventy bio
Our name, 2seventy bio, reflects why we do what we do - TIME. Cancer rips time away, and our goal is to work at the maximum speed of translating human thought into action – 270 miles per hour – to give the people we serve more time. With a deep understanding of the human body’s immune response to tumor cells and how to translate cell therapies into practice, we’re applying this knowledge to deliver the first FDA-approved CAR T cell therapy for multiple myeloma to as many patients as possible. Importantly, we remain focused on accomplishing our mission by staying genuine and authentic to our “why” and keeping our people and culture top of mind every day. For more information, visit www.2seventybio.com.
Follow 2seventy bio on social media: X (Twitter) and LinkedIn.
2seventy bio is a trademark of 2seventy bio, Inc.
Cautionary Note Regarding Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of applicable laws and regulations. These statements include, but are not limited to: statements about the discontinuation of the ongoing Phase 3 KarMMa-9 study, including the potential cost savings; statements regarding expected ABECMA (ide-cel)
View source version on businesswire.com: https://www.businesswire.com/news/home/20240925722000/en/
Investors and Media:
Vicki Eatwell, CFO
vicki.eatwell@2seventybio.com
Morgan (
Morgan.adams@2seventybio.com
Source: 2seventy bio, Inc.
FAQ
Why did 2seventy bio discontinue enrollment in the KarMMa-9 study for Abecma (TSVT)?
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