Tisagenlecleucel

CHICAGO Funding cancer research isn't usually a political flashpoint. But as the Trump administration signals its desire to drastically cut the budget of the National Cancer Institute, the American Society of Clinical Oncology is finding itself forced to defend what is usually a bipartisan policy.“If implemented, these cuts would be devastating to the pace and progress of cancer research in America,“ ASCO CEO Clifford Hudis said in a Friday statement. ASCO maintains that federally funded cancer research is the single best investment our country has ever made.“ASCO's annual meeting this year provides a convincing example. A large study funded by the NCI found that adding the immunotherapy Tecentriq to a common chemotherapy regimen can halve the risk of disease recurrence or death in patients with a certain form of colon cancer. These data, said one of the researchers involved, will change clinical practice.But they may not have been as easily obtained without the help of the NCI, said Joel Saltzman, vice chair of regional oncology at the Cleveland Clinics Taussig Cancer Center, in a press conference held for reporters. This was a study that took five years to accrue patients to. It was open at 300 sites, he said. A study like this would just not have been feasible without the federal funding from the National Cancer Institute. Ned PagliaruloA $1 billion dollar posterOn Saturday, doctors and biotechnology executives got a closer look at Pfizers latest billion-dollar acquisition, a bispecific antibody from Chinas 3SBio, code-named SSGJ-707, that blocks the proteins PD-1 and VEGF.3SBio, which licensed Pfizers rights to SSGJ-707 for $1.25 billion upfront, presented mid-stage study data in a poster session that hinted at the drugs promise in non-small cell lung cancer. The Phase 2 study involved previously untreated people whose tumors express the protein PD-L1.Treatment shrank tumors in about two-thirds of participants given a dose of 10 milligrams infused every three weeks, with lower response rates at doses of 5, 20 and 30 milligrams. Nearly all patients experienced side effects, notably liver enzyme elevations and increased cholesterol. More than half on the 20 and 30 milligram doses had side effects judged to be severe or medically significant, while on lower doses only about 1 in 4 did.Researchers, led by Lin Wu of Hunan Cancer Hospital in China, wrote that the data support further evaluation of the 10 milligram dose. Four trials are listed as underway at clinicaltrials.gov, with a fifth planned.The 3SBio data came a day after Summit Pharmaceuticals and Akeso released Phase 3 data from their PD-1/VEGF combination treatment, now one of the most closely watched drugs in all of oncology. Jonathan GardnerAstraZenecas ad blitzWalk around Chicago this weekend and youre likely to see an ad for AstraZenecas cancer research, often emblazoned on the sides of bus stops. Take an Uber to McCormick Place, the convention center that houses ASCO for five days, and you might be reminded by an ad on the app that its been 10 years since the initial approval of Tagrisso, which now ranks among the top 20 most lucrative pharmaceutical products by sales.All pharma companies advertise at ASCO, of course, but AstraZeneca has a lot of talk about this year. For the seventh year in a row, the maker of Tagrisso, Imfinzi and Enhertu has trial data highlighted in the ASCO plenary session an occasion AstraZeneca executives are marking with a pin that weaves the number 7 between the A and Z of their companys logo.An AstraZeneca ad in downtown ChicagoNed Pagliarulo/BioPharma DiveData from one such highlighted study indicate that an AstraZeneca drug called camizestrant could be swapped in for so-called aromatase inhibitors as part of an initial treatment regimen for the most common form of advanced breast cancer. Aromatase inhibitors, one AstraZeneca bus stop ad reminds possibly confused Chicagoans, were state of the art in the 1990s. Then again, so were videotapes, it adds.Camizestrant is not yet approved, but AstraZeneca expects it will eventually become a major product. Its importance is reflected in its name: the cami root is a nod to the British drugmakers Cambridge laboratories, where camizestrant originated. Ned PagliaruloAn unexpected gene therapy spotlightHaydar Frangoul, a pediatric hematologist and oncologist, is used to presenting at medical meetings. But ASCO isnt the usual forum for Frangoul, who played a major role in testing the CRISPR gene editing treatment Casgevy for sickle cell disease.I was shocked they wanted to hear about sickle cell at ASCO, Frangoul said Saturday, opening a joint session on gene therapy held by ASCO and the American Association of Cancer Research.Frangoul walked the assembled cancer doctors and researchers through the study that supported Casgevys U.S. approval in December 2023. Jimi Olaghere, a patient in that study, described his life before treatment, and how Casgevy has changed it.Their reflections spotlighted what gene therapy can accomplish, even as the field falters amid waning investor interest, dried-up funding and persistent safety concerns.Its an important reminder even in oncology, which is perhaps not as often associated with gene therapy as rare diseases like sickle cell. Kymriah, a CAR-T cell treatment for leukemia, was the first therapy based on gene transfer technology to be cleared by the FDA. Five other CAR-Ts have been approved since, as have several other T cell-based medicines.More are likely coming, too. The session closed with a presentation from Katy Revzani, head of the MD Anderson Cancer Centers cell therapy institute, about her hospitals research exploring NK cell therapy, which she said could be safer and easier to produce off of the shelf. Ned Pagliarulo '

30 scientific abstracts will be presented using clonoSEQ for MRD assessment across multiple types of blood cancersSEATTLE, May 30, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in 30 presentations, including a total of 14 oral presentations, across the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3 in Chicago and the European Hematology Association (EHA) Congress taking place June 12-15 in Milan. These presentations include notable new data supporting the clinical actionability of clonoSEQ in both multiple myeloma (MM) and chronic lymphocytic leukemia (CLL). "The breadth of new MRD evidence being shared across various blood cancer types at ASCO and EHA this year highlights the transformative impact MRD is having on clinical care and drug development," said Susan Bobulsky, Chief Commercial Officer, MRD, Adaptive Biotechnologies. "These data presentations are a testament to the central role that clonoSEQ MRD testing now plays in clinical management and drug development across lymphoid cancers, particularly when combined with several clonoSEQ data presentations in diffuse large B-cell lymphoma (DLBCL) anticipated at the 18th International Conference on Malignant Lymphoma (iCML) on June 17-21, 2025 in Lugano, Switzerland." Selected presentations include: Data advancing the clinical actionability of clonoSEQ MRD testing Results from MIDAS, a phase 3 randomized study of 718 transplant-eligible, newly diagnosed multiple myeloma (NDMM) patients, demonstrate the use of MRD status to guide therapy post-induction. (ASCO Abstract 7500, June 3, 9:45-9:57 a.m. CDT, S100bc, McCormick Place Convention Center)Interim data from ADVANCE, a phase 2 randomized study of 306 transplant-eligible patients with NDMM shows the impact of MRD-guided assessments post-induction (ASCO Abstract 7503, June 3, 10:21-10:33 a.m. CDT, S100bc, McCormick Place Convention Center)Interim results from VENETOSTOP, a phase 2 study of 66 CLL patients, report the use of MRD status to shorten duration of venetoclax-based therapy. (EHA Abstract PS1568, June 14, 6:30 p.m. CEST, Poster Hall, Milano Convention Centre) Studies utilizing clonoSEQ MRD assessment as a critical indicator of quadruplet regimen efficacy in multiple myeloma Results from the phase 3 IsKia study of 151 transplant-eligible NDMM patients demonstrates increased rates of sustained MRD negativity at 10-6 with isatuximab plus carfilzomib, lenalidomide, and dexamethasone. (ASCO Abstract 7502, June 3, 10:09-10:21 a.m. CDT, S100bc, McCormick Place Convention Center) Follow-up data from PERSEUS, a phase 3 trial of 709 transplant-eligible patients with NDMM reports the impact of sustained MRD negativity status on progression free survival (PFS) with subcutaneous daratumumab plus bortezomib, lenalidomide and dexamethasone (D-VRd) induction and DR maintenance. (ASCO Abstract 7501, June 3, 9:57-10:09 a.m. CDT, S100bc, McCormick Place Convention Center) Results from DREAMM-8, a Phase 3 study in 302 patients with relapsed or refractory multiple myeloma, found superior PFS and higher MRD negativity rates in patients treated with belantamab mafodotin plus pomalidomide and dexamethasone (BPd) as compared to standard-of-care pomalidomide, bortezomib, and dexamethasone (PVd). (ASCO Abstract 7515, June 2, 9:00-9:06 a.m. CDT E450b, McCormick Place Convention Center) Data to be presented at ASCO: Presentation Type and NumberTitlePresentation TimingB-Cell Acute Lymphoblastic LeukemiaPoster Presentation6540Initial results from a phase II study of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH) ± rituximab (R) + tafasitamab (tafa) for adults with newly-diagnosed (ND) Philadelphia chromosome negative (Ph-) B lymphoblastic leukemia (B-ALL)Sunday, June 19 a.m.-12 p.m. CDTPoster Presentation6543Brexucabtagene autoleucel (Brexu-cel) as consolidation treatment in adults with B-cell acute lymphoblastic leukemiaSunday, June 19 a.m.-12 p.m. CDTMultiple MyelomaOral Presentation7500*MRD-driven strategy following IsaKRD induction in transplant-eligible NDMM: Primary endpoints of the phase 3 MIDAS trialTuesday, June 39:45-9:57 a.m. CDTOral Presentation7501Subcutaneous daratumumab (Dara) + bortezomib/lenalidomide/dexamethasone (VRd) with Dara + lenalidomide (DR) maintenance in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM): Analysis of sustained minimal residual disease negativity in the phase 3 PERSEUS trialTuesday, June 39:57-10:09 a.m. CDTOral Presentation7502Sustained MRD negativity in patients with newly diagnosed multiple myeloma treated with carfilzomib-lenalidomide-dexamethasone with or without isatuximab (phase III IsKia trial)Tuesday, June 310:09-10:21 a.m. CDTOral Presentation7503*Randomized, multi-center study of carfilzomib, lenalidomide, and dexamethasone (KRd) with or without daratumumab (D) in patients with newly diagnosed multiple myeloma (NDMM): The ADVANCE clinical trialTuesday, June 310:21-10:33 a.m. CDTOral Presentation7507*Long-term (≥5 year) remission and survival after treatment with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 patients (pts) with relapsed/refractory multiple myeloma (RRMM)Tuesday, June 311:57 a.m.-12:09 p.m. CDTOral Presentation7515Minimal residual disease (MRD) negativity (neg) in patients (pts) with relapsed or refractory multiple myeloma (RRMM) treated with belantamab mafodotin plus pomalidomide and dexamethasone (BPd) vs pomalidomide, bortezomib, and dexamethasone (PVd): Analysis from the DREAMM-8 trialMonday, June 29-9:06 a.m. CDTOral Presentation7516Daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd) in patients with newly diagnosed multiple myeloma (NDMM): Subgroup analysis of transplant-ineligible (TIE) patients in the phase 3 CEPHEUS studyMonday, June 29:06-9:12 a.m. CDTASCO Oral Presentation7517*Isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) in newly diagnosed multiple myeloma (NDMM): Outcomes in patients with 1q21+ status in the phase 3 IMROZ studyMonday, June 29:12-9:18 a.m. CDTPoster Presentation7529Daratumumab + bortezomib, lenalidomide, and dexamethasone (DVRd) vs VRd in transplant-ineligible (TIE)/transplant-deferred (TD) newly diagnosed multiple myeloma (NDMM): Phase 3 CEPHEUS trial cytogenetic subgroup analysisSunday, June 19 a.m.-12 p.m. CDTPoster Presentation7535Carfilzomib, lenalidomide, and dexamethasone (KRd) as maintenance therapy after autologous stem-cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma (NDMM)Sunday, June 19 a.m.-12 p.m. CDTASCO Poster Presentation7551*Positron emission tomography with computed tomography (PET/CT) and minimal residual disease (MRD) for efficacy assessment in transplant-ineligible newly diagnosed myeloma (Ti NDMM) patients (pts): IMROZ analysisSunday, June 19 a.m.-12 p.m. CDT Data to be presented at EHA: Presentation Type and NumberTitlePresentation TimingB-Cell Acute Lymphoblastic LeukemiaOral PresentationS112Safety and efficacy of single-agent subcutaneous blinatumomab in adults with relapsed/refractory (R/R) b-cell acute lymphoblastic leukemia (B-ALL): results from a phase 1/2 dose expansion studySunday, June 1511:30-11:45 a.m. CESTOral PresentationS117Safety and efficacy of AZD0486 in adolescent and adult patients with relapsed or refractory b-cell acute lymphoblastic leukemia: early results from the phase 1/2 SYRUS studyFriday, June 135:30-5:45 p.m. CESTPoster PresentationPF372Donor-derived, allogeneic CD19/CD22-CAR T cells with myeloablative graft-engineered Allo-HCT for high-risk B-ALLFriday, June 136:30 p.m. CESTChronic Lymphocytic LeukemiaPoster PresentationPF575Preliminary results of the ongoing multicenter, phase 2 study of retreatment with venetoclax plus obinutuzumab (ReVenG) in patients with recurrent chronic lymphocytic leukemia (CLL)Friday, June 136:30 p.m. CESTPoster PresentationPS1568Using minimal residual disease status to guide venetoclax treatment duration in patients with chronic lymphocytic leukemia: interim results from the phase II VENETOSTOP studySaturday, June 146:30 p.m. CESTFollicular LymphomaPoster PresentationPF881Epcoritamab monotherapy demonstrates deep and durable responses at 3-year follow-up in patients with relapsed/refractory follicular lymphomaFriday, June 136:30 p.m. CESTPoster PresentationPS21504-year update of phase 2 ELARA trial: clinical outcomes of tisagenlecleucel in patients (pts) with high-risk relapsed/refractory follicular lymphoma (R/R FL)Saturday, June 146:30 p.m. CESTMantle Cell Lymphoma Poster PresentationPF882Minimal residual disease with bendamustine-rituximab with or without acalabrutinib in patients with previously untreated mantle cell lymphoma: results from the phase 3 ECHO trialFriday, June 136:30 p.m. CESTMultiple MyelomaOral PresentationS201Phase 2 registrational study of anitocabtagene autoleucel for relapsed and/or refractory multiple myeloma (RRMM): updated results from IMMAGINE-1Saturday, June 145:15-5:30 p.m. CESTOral PresentationS205*Minimal residual disease-driven strategy following isatuximab-carfilzomib-lenalidomide-dexamethasone induction in transplant-eligible newly diagnosed multiple myeloma: Primary endpoints of the phase 3 MIDAS trialSunday, June 1511:00-11:15 a.m. CESTOral Presentation S207*A randomized, multi-center study of carfilzomib, lenalidomide and dexamethasone (KRd) with or without daratumumab (D) for the treatment of patients with newly diagnosed multiple myeloma (NDMM): The ADVANCE clinical trialSunday, June 1511:30-11:45 a.m. CESTOral PresentationS208*Analysis of sustained MRD negativity in patients with newly diagnosed multiple myeloma treated with carfilzomib-lenalidomide-dexamethasone with or without isatuximab (phase III IsKia trial)Sunday, June 1511:45 a.m.-12 p.m. CESTPoster PresentationPF727Isa-vrd improves outcomes in high-risk (HR) newly diagnosed transplant-ineligible multiple myeloma (NDMM TI) using the IMS/IMWG consensus HR definition: results from the BENEFIT phase 3 trial (IFM 2020-05)Friday, June 136:30 p.m. CESTPoster Presentation PF729*Isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) in newly diagnosed multiple myeloma (NDMM): outcomes in patients with 1q21+ status in the phase 3 IMROZ studyFriday, June 136:30 p.m. CESTPoster PresentationPF750Isatuximab, bortezomib, lenalidomide, dexamethasone (Isa-VRd) in patients with transplant-ineligible (TI) newly diagnosed myeloma (NDMM) and plasmacytomas: IMROZ subgroup analysisFriday, June 136:30 p.m. CESTPoster PresentationPF754Interim analysis of MRD-guided maintenance therapy with belantamab mafodotin and lenalidomide after Auto-HCT in newly diagnosed multiple myelomaFriday, June 136:30 p.m. CESTPoster Presentation PS1722*Positron emission tomography with computed tomography and minimal residual disease for efficacy assessment in transplant-ineligible newly diagnosed myeloma patients: IMROZ analysisSaturday, June 146:30 p.m. CEST *Indicates data to be presented at both ASCO and EHA. About clonoSEQ clonoSEQ® is the first and only FDA-cleared in vitro diagnostic (IVD) test for detecting and tracking minimal (or measurable) residual disease (MRD) in patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) using bone marrow, and in patients with chronic lymphocytic leukemia (CLL) using blood or bone marrow. clonoSEQ is also available in diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) and other lymphoid cancers and specimen types as a CLIA-validated laboratory developed test (LDT). clonoSEQ is covered by Medicare for MM, CLL, ALL, DLBCL and MCL. clonoSEQ identifies and quantifies DNA sequences in malignant cells—detecting one cancer cell in one million healthy cells—to help clinicians and researchers assess and monitor MRD with precision over time. It delivers standardized, sensitive results that inform treatment decisions, predict outcomes, and detect relapses earlier. clonoSEQ is CE-marked under the EU In Vitro Diagnostic Regulation (IVDR). For intended use details in the EU, see the instructions for use, available on request. To review the FDA-cleared uses of clonoSEQ, visit clonoSEQ.com/technical-summary. About Adaptive Biotechnologies Adaptive Biotechnologies ("we" or "our") is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature's most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient. Forward Looking Statements This press release contains forward-looking statements that are based on management's beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. In some cases, you can identify forward-looking statements by the words "may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections regarding the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. ADAPTIVE INVESTORS Karina Calzadilla, Vice President, Investor Relations and FP&A 201-396-1687 investors@adaptivebiotech.com ADAPTIVE MEDIAErica Jones, Associate Corporate Communications Director206-279-2423media@adaptivebiotech.com