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ADC Therapeutics Announces Updated Data from LOTIS-7 Clinical Trial Presented at the European Hematology Association 2025 Congress
Prnewswire· 2025-06-12 10:30
Core Insights - ADC Therapeutics announced promising results from the LOTIS-7 Phase 1b trial, showing a 93.3% overall response rate (ORR) and an 86.7% complete response (CR) rate in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) treated with ZYNLONTA® and glofitamab [1][3][4] Efficacy Data - Among 30 efficacy evaluable patients, 28 achieved an overall response, with 26 achieving complete responses [3] - 25 out of 26 patients who achieved CR remained in CR at the data cut-off [1][3] - Median time to CR was 80 days for the 120 µg/kg dose and 42 days for the 150 µg/kg dose [3] - 12 patients converted from stable disease or partial response to CR over time [3] - Of 6 patients previously treated with CAR-T, 5 achieved CR [3] Safety Profile - The combination treatment was generally well tolerated, with no dose-limiting toxicities (DLTs) reported [3] - Among 41 safety evaluable patients, the most common grade 3 or higher treatment-emergent adverse events (TEAEs) included neutropenia (24.4%), anemia (9.8%), and increased liver enzymes [3] - Cytokine release syndrome (CRS) was observed in 23.8% of patients at the 150 µg/kg dose, all Grade 1, while 55% experienced CRS at the 120 µg/kg dose [3] Study Expansion - The company is expanding enrollment for the LOTIS-7 trial to 100 patients at the 150 µg/kg dose of ZYNLONTA [1][4] - The updated data will be presented at the European Hematology Association 2025 Congress and the 18th International Conference on Malignant Lymphoma [4] About ZYNLONTA - ZYNLONTA is a CD19-directed antibody drug conjugate (ADC) approved for treating adult patients with r/r large B-cell lymphoma after two or more lines of systemic therapy [9][13] - The drug works by binding to CD19-expressing cells and delivering a potent payload that leads to tumor cell death [8]
ADC Therapeutics Reports First Quarter 2025 Financial Results and Provides Operational Update
Prnewswire· 2025-05-14 12:00
Core Insights - ADC Therapeutics reported promising data from the LOTIS-7 trial, showing an overall response rate (ORR) of 95.5% and a complete response (CR) rate of 90.9% for ZYNLONTA® in combination with glofitamab in patients with relapsed/refractory DLBCL [1][3][9] - The company expects its cash runway to extend into the second half of 2026, allowing for multiple catalysts to be funded [1][9] - The CEO expressed confidence in ZYNLONTA's potential as a best-in-class treatment in a dynamic market, particularly as the company progresses with the LOTIS-5 confirmatory trial [2][3] Financial Performance - For Q1 2025, ZYNLONTA generated net product revenues of $17.4 million, slightly down from $17.8 million in Q1 2024 [9][21] - License revenues and royalties increased significantly to $5.6 million from $0.2 million in the same period last year, driven by a milestone payment related to ZYNLONTA's approval in Canada [9][21] - Research and development expenses rose to $28.9 million from $25.7 million year-over-year, reflecting increased spending on next-generation ADCs [9][21] - The net loss for Q1 2025 was $38.6 million, an improvement from a net loss of $46.6 million in Q1 2024 [9][21] Clinical Development Updates - The LOTIS-7 trial has reached 40 patient enrollments in its dose expansion arm, with updates expected in the second half of 2025 [1][3] - The LOTIS-5 trial's safety run-in data will also be presented at EHA2025, showing no new safety signals and encouraging antitumor activity [3] - An abstract for marginal zone lymphoma data will be presented at ICML, highlighting the high rate of complete responses in a phase 2 study [3] Company Overview - ADC Therapeutics is a leader in the field of antibody drug conjugates (ADCs), focusing on transforming treatment paradigms for hematologic malignancies and solid tumors [11][12] - ZYNLONTA has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory DLBCL after two or more lines of systemic therapy [8][12]
ADC Therapeutics Announces Presentation of LOTIS-7 Clinical Trial Data at the European Hematology Association 2025 Congress (EHA2025) and the 18th International Conference on Malignant Lymphoma (ICML)
Prnewswire· 2025-05-14 11:45
Core Insights - ADC Therapeutics announced promising results from the LOTIS-7 Phase 1b clinical trial, showing an overall response rate (ORR) of 95.5% and a complete response (CR) rate of 90.9% among 22 evaluable patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) [1][4] - The combination of ZYNLONTA and glofitamab demonstrated a manageable safety profile, with adverse events consistent with known profiles of the individual agents [2][4] - Updated data will be presented at the European Hematology Association 2025 Congress (EHA2025) and the International Conference on Malignant Lymphoma (ICML) [1][5] Efficacy and Safety Data - In the efficacy evaluable population, the ORR was 95.5% (21 out of 22 patients), and the CR rate was 90.9% (20 out of 22 patients) [4] - Among 31 patients treated, the most common Grade ≥3 treatment-emergent adverse event (TEAE) was neutropenia at 32.3% [4] - Other notable Grade 3/4 TEAEs included generalized edema, pericardial effusion, photosensitivity reaction, rash, sepsis, and pneumonia, each at 3.2% [4] Presentation Details - The LOTIS-7 data will be presented in a poster session at EHA2025 on June 14, 2025, with the presenting author being Juan Pablo Alderuccio, MD [3][5] - An oral encore presentation will take place at ICML on June 20, 2025, also featuring Juan Pablo Alderuccio as the presenting author [5] Study Overview - LOTIS-7 is a Phase 1b global multicenter study evaluating ZYNLONTA in combination with various agents, including glofitamab, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma [6] - The study includes a dose escalation phase and a dose expansion phase, with primary endpoints focusing on safety and tolerability [6] About ZYNLONTA - ZYNLONTA is a CD19-directed antibody drug conjugate (ADC) approved for treating adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy [9][12] - The drug works by binding to CD19-expressing cells and delivering a potent payload that leads to tumor cell death [8]
Zymeworks Inc. (ZYME) Reports Q1 Loss, Tops Revenue Estimates
ZACKS· 2025-05-08 22:56
Company Performance - Zymeworks Inc. reported a quarterly loss of $0.30 per share, better than the Zacks Consensus Estimate of a loss of $0.45, and an improvement from a loss of $0.42 per share a year ago, resulting in an earnings surprise of 33.33% [1] - The company posted revenues of $27.11 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 57.36%, compared to revenues of $10.03 million in the same quarter last year [2] - Over the last four quarters, Zymeworks has surpassed consensus EPS estimates four times, but has only topped consensus revenue estimates once [2] Stock Outlook - Zymeworks shares have declined approximately 22.5% since the beginning of the year, while the S&P 500 has decreased by 4.3% [3] - The company's earnings outlook will be crucial for future stock performance, with current consensus EPS estimates at -$0.51 for the coming quarter and -$1.75 for the current fiscal year [4][7] Industry Context - The Medical - Biomedical and Genetics industry, to which Zymeworks belongs, is currently ranked in the top 33% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Zymeworks' stock performance [5]
ADC Therapeutics to Host First Quarter 2025 Financial Results Conference Call on May 14, 2025
Prnewswire· 2025-05-08 11:15
Core Insights - ADC Therapeutics SA is a global leader in antibody drug conjugates (ADCs) and will host a conference call on May 14, 2025, to report Q1 2025 financial results and operational updates [1][2][3] Company Overview - ADC Therapeutics is advancing proprietary ADC technology aimed at transforming treatment for patients with hematologic malignancies and solid tumors [3] - The company is based in Lausanne, Switzerland, with operations in London and New Jersey [5] Product Development - ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy [4] - ZYNLONTA is also being developed in combination with other agents and in earlier lines of therapy, alongside multiple ADCs in ongoing clinical and preclinical development [4]
Kura Oncology (KURA) Reports Q1 Loss, Lags Revenue Estimates
ZACKS· 2025-05-01 22:30
分组1 - Kura Oncology reported a quarterly loss of $0.66 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.51, and compared to a loss of $0.59 per share a year ago, indicating an earnings surprise of -29.41% [1] - The company posted revenues of $14.11 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 88.19%, and this is a significant increase from zero revenues a year ago [2] - Kura Oncology shares have declined approximately 24.7% since the beginning of the year, contrasting with the S&P 500's decline of -5.3% [3] 分组2 - The earnings outlook for Kura Oncology is mixed, with the current consensus EPS estimate for the coming quarter at -$0.62 on revenues of $41.42 million, and for the current fiscal year at -$1.66 on revenues of $193.66 million [7] - The Medical - Biomedical and Genetics industry, to which Kura Oncology belongs, is currently ranked in the top 32% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]
AC Immune (ACIU) Reports Q1 Loss, Lags Revenue Estimates
ZACKS· 2025-04-30 13:15
Core Viewpoint - AC Immune reported a quarterly loss of $0.21 per share, slightly better than the Zacks Consensus Estimate of a loss of $0.22, indicating a 4.55% earnings surprise [1] - The company has shown mixed performance in revenue, with $1.1 million reported for the quarter, missing the consensus estimate by 3.42% [2] Financial Performance - Over the last four quarters, AC Immune has surpassed consensus EPS estimates three times [2] - The company has experienced a significant decline in share price, losing about 37% since the beginning of the year, compared to a 5.5% decline in the S&P 500 [3] Future Outlook - The future performance of AC Immune's stock will largely depend on management's commentary during the earnings call and the earnings outlook [4][6] - Current consensus EPS estimate for the upcoming quarter is -$0.20 on revenues of $3.07 million, and for the current fiscal year, it is -$0.86 on revenues of $36.52 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which AC Immune belongs, is currently ranked in the top 32% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8]
ADC Therapeutics Announces Preclinical Data Highlighted at the American Association for Cancer Research Annual Meeting 2025
Prnewswire· 2025-04-28 11:00
Core Insights - ADC Therapeutics presented promising data on exatecan-based antibody drug conjugates (ADCs) targeting Claudin-6, PSMA, and ASCT2 at the AACR Annual Meeting 2025, indicating their potential in treating various cancers [1][2][3] Group 1: ADC Therapeutics Overview - ADC Therapeutics is a global leader in the field of antibody drug conjugates (ADCs), focusing on transforming treatment paradigms for patients with hematologic malignancies and solid tumors [5] - The company has received FDA accelerated approval for its CD19-directed ADC ZYNLONTA for treating relapsed or refractory diffuse large B-cell lymphoma [6] Group 2: Research Findings - ADCT-242, targeting Claudin-6, showed potent anti-tumor activity in ovarian and non-small cell lung cancer models, demonstrating good tolerability in preclinical studies [2][8] - ADCT-241, a PSMA-targeting ADC, exhibited antitumor activity in xenograft and patient-derived models, with well-tolerated results in rats and cynomolgus monkeys [2][3] - HuB14-VA-PL2202, an ASCT2-targeting ADC, demonstrated specific antitumor activity in both solid and hematological cancer cell lines, also showing good tolerability in cynomolgus monkeys [3]
ADC Therapeutics to Participate in the 24th Annual Needham Virtual Healthcare Conference
Prnewswire· 2025-04-01 11:15
Company Overview - ADC Therapeutics SA is a commercial-stage global leader in the field of antibody drug conjugates (ADCs) [3] - The company is focused on transforming treatment paradigms for patients with hematologic malignancies and solid tumors [3] Recent Developments - CEO Ameet Mallik will present a company overview at the 24th Annual Needham Virtual Healthcare Conference on April 8, 2025 [1] - A live webcast of the presentation will be available on the company's website, with a replay accessible for approximately 30 days [2] Product Pipeline - ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy [4] - ZYNLONTA is also being developed in combination with other agents and in earlier lines of therapy [4] - The company has multiple ADCs in ongoing clinical and preclinical development [4] Company Operations - ADC Therapeutics is based in Lausanne, Switzerland, with operations in London, the San Francisco Bay Area, and New Jersey [5]
ADC Therapeutics to Participate in the 24th Annual Needham Virtual Healthcare Conference
Prnewswire· 2025-04-01 11:15
Company Overview - ADC Therapeutics SA is a commercial-stage global leader in the field of antibody drug conjugates (ADCs) [3] - The company is focused on transforming treatment paradigms for patients with hematologic malignancies and solid tumors [3] Recent Developments - CEO Ameet Mallik will present a company overview at the 24th Annual Needham Virtual Healthcare Conference on April 8, 2025, at 8:00 a.m. ET [1] - A live webcast of the presentation will be available on the company's website, with a replay accessible for approximately 30 days [2] Product Pipeline - ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy [4] - ZYNLONTA is also being developed in combination with other agents and in earlier lines of therapy [4] - The company has multiple ADCs in ongoing clinical and preclinical development [4] Company Operations - ADC Therapeutics is headquartered in Lausanne, Switzerland, with operations in London, the San Francisco Bay Area, and New Jersey [5]