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- INFECTIONS FOLLOWING BISPECIFIC ANTIBODIES IN MYELOMA: A SYSTEMATIC REVIEW AND META-ANALYSIS (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_1948;
Despite promising efficacy in MM, BsAbs may come with substantial infection risk, warranting more detailed analysis of infections and immune phenotyping to guide targeted supportive care. Table
- Tecvayli (teclistamab) / Genmab, J&J
TECLISTAMAB REDUCES POLYCLONAL IMMUNOGLOBULIN LEVELS AND IMPAIRS VACCINATION RESPONSES IN HEAVILY PRETREATED MM PATIENTS (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_1947;
Table Vaccination response rates following S. pneumoniae (conjugated PCV-13 [prevenar], followed by the polysaccharide PPV-23 vaccine [pneumovax] 8 weeks later ) and H. influenzae vaccination (Act-Hib) was significantly lower in TEC-treated pts (8% and 6%, resp.) versus response in newly diagnosed MM (76% and 88%), daratumumab-na
- Tecvayli (teclistamab) / Genmab, J&J
DURABILITY OF RESPONSES WITH BIWEEKLY DOSING OF TECLISTAMAB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA ACHIEVING A CLINICAL RESPONSE IN THE MAJESTEC-1 STUDY (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_1232;
P1, P2
Vaccination response rates following S. pneumoniae (conjugated PCV-13 [prevenar], followed by the polysaccharide PPV-23 vaccine [pneumovax] 8 weeks later ) and H. influenzae vaccination (Act-Hib) was significantly lower in TEC-treated pts (8% and 6%, resp.) versus response in newly diagnosed MM (76% and 88%), daratumumab-na Overall, patients from the MajesTEC-1 study who transitioned from QW to less frequent Q2W dosing of teclistamab had sustained remission, with a median duration of response of 20.5 months from the date of switch.
- Tecvayli (teclistamab) / Genmab, J&J
TECLISTAMAB IN COMBINATION WITH LENALIDOMIDE IN PREVIOUSLY TREATED PATIENTS WITH MULTIPLE MYELOMA IN THE PHASE 1B MULTICOHORT MAJESTEC-2 STUDY (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_1226;
P1b, P3
The safety profile was consistent with tec and len individually, with no new safety signals, no dose-limiting toxicities, and an infection rate consistent withtec alone, supporting the potential of this combination. Tec + len as maintenance therapy after autologous stem cell transplant in pts with newly diagnosed MM will be evaluated in the randomized phase 3 MajesTEC-4 study (NCT05243797).
- Actemra IV (tocilizumab) / Roche, JW Pharma, Tecvayli (teclistamab) / Genmab, J&J
EVALUATION OF PROPHYLACTIC TOCILIZUMAB (TOCI) FOR THE REDUCTION OF CYTOKINE RELEASE SYNDROME (CRS) TO INFORM THE MANAGEMENT OF PATIENTS (PTS) TREATED WITH TECLISTAMAB IN MAJESTEC-1 (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_1215;
A single dose of toci before teclistamab treatment appeared to reduce the incidence of CRS relative to the overall MajesTEC-1 study population with no new safety signals and no evidence of impact on response to teclistamab considering the short follow-up. Prophylactic toci has the potential to reduce CRS risk in pts with disease profiles suitable for outpatient dosing, reducing the burden of hospitalization during teclistamab step-up dosing.
- Tecvayli (teclistamab) / Genmab, J&J
LONG-TERM FOLLOW-UP FROM MAJESTEC-1 OF TECLISTAMAB, A B-CELL MATURATION ANTIGEN (BCMA) X CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM) (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_1168;
P1, P2
Prophylactic toci has the potential to reduce CRS risk in pts with disease profiles suitable for outpatient dosing, reducing the burden of hospitalization during teclistamab step-up dosing. Pts had a median of 5 prior LOT (range, 2
- Tecvayli (teclistamab) / Genmab, J&J
PATIENT-REPORTED OUTCOMES FOR TECLISTAMAB VERSUS REAL-WORLD PHYSICIAN (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_1165;
P=N/A, P2
Thishighlights the positive impact teclistamab can have on health-related quality of life in addition to significant efficacy benefits to help address the high unmet need for this patient population. Real world data, Patient reported outcomes, Multiple myeloma, Clinical trial
- Tecvayli (teclistamab) / Genmab, J&J
COMMERCIAL TECLISTAMAB IN ANTI-BCMA THERAPY EXPOSED RELAPSED REFRACTORY MULTIPLE MYELOMA PATIENTS: THE MSKCC EXPERIENCE. (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_1158;
Tec remains effective in relapsed or refractory multiple myeloma despite prior exposure to anti-BCMA therapies, though exposure to multiple prior anti-BCMA therapies may be predictive of diminished efficacy. Clinical data on additional patients will be presented at the meeting.
- Tecvayli (teclistamab) / Genmab, J&J
AN OUTPATIENT MODEL FOR TECLISTAMAB STEP-UP DOSING ADMINISTRATION (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_1142;
Both patients were treated with 1 dose of tocilizumab, and the patient with ICANS also received dexamethasone, with prompt resolution of symptoms. Our outpatient teclistamab administration model with close toxicity monitoring and prompt hospitalization fortoxicity management is safe and feasible in heavily pre-treated RRMM patients and allows significant reduction of inpatient stay, resulting in significant healthcare savings and improvement of patients' experience.
- Tecvayli (teclistamab) / Genmab, J&J, talquetamab (JNJ-64407564) / J&J
ACQUIRED RESISTANCE TO BISPECIFIC ANTIBODIES BY GENETIC OR EPIGENETIC INACTIVATION OF THE TARGET IN MULTIPLE MYELOMA (Hall Symann) - May 12, 2023 - Abstract #EHA2023EHA_919;
Pre-existing chromosome 12p deletion may favor the emergence of resistant subcloneswith inactivation of the second GPRC5D allele, mirroring previous results on BCMA CAR-T resistance. We anticipate that a thorough monitoring of the genetic and epigenetic status of the targets will help guiding the choice of BsAb and early detection of resistance in MM.
- || Darzalex (daratumumab) / J&J, Tecvayli (teclistamab-cqyv) / Genmab, J&J, Talvey (talquetamab-tgvs) / J&J
New P2 trial: GEM-TECTAL: Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma (clinicaltrials.gov) - May 8, 2023
P2, N=30, Not yet recruiting, Sponsor: PETHEMA Foundation
- | Tecvayli (teclistamab-cqyv) / Genmab, J&J
Trial completion date, IO biomarker: MajesTEC-1: Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - May 6, 2023
P1, N=282, Recruiting, Sponsor: Janssen Research & Development, LLC
We anticipate that a thorough monitoring of the genetic and epigenetic status of the targets will help guiding the choice of BsAb and early detection of resistance in MM. Trial completion date: Aug 2025 --> May 2025
- ||| Tecvayli (teclistamab) / Genmab, J&J, Blenrep (belantamab mafodotin) / GSK
Clinical: Same small but real group as always - patients who live too far away for weekly teclistamab and aren’t eligible / don’t have a 1-2mo caregiver for CAR-T. Every few months I have to remove a “will plan for belantamab locally at PD” from my updated notes for these patients… (Twitter) - May 2, 2023
- || Abecma (idecabtagene vicleucel) / BMS, 2seventy bio, Tecvayli (teclistamab) / Genmab, J&J
To me… what possibly can belamaf offer over Teclistamab/Elrantamab or cilta/ide-cel? Convince me of that then maybe there is a “need” for it. (Twitter) - May 2, 2023
- |||| Tecvayli (teclistamab) / Genmab, J&J
Pleasure discussing the nuts & bolts of bsAbs in #MMsm with @UrviShahMD @MSKCancerCenter! We focused on the practicalities of teclistamab administration - lots to learn from how MSKCC is setting it up at their satellite sites! Cc @szusmani (Twitter) - Apr 30, 2023
- |||| Tecvayli (teclistamab) / Genmab, J&J
In this latest episode of ASTCT Talks, @RahulBanerjeeMD sits down with @UrviShahMD, to discuss #CART vs bsAbs among academic audiences, teclistamab, infections in published trials of bsAbs in myeloma and more. Listen now: https://t.co/dUDxT7MoYT (Twitter) - Apr 30, 2023
- ||| Tecvayli (teclistamab) / Genmab, J&J
Teclistamabe é aprovado no Brasil para o tratamento do mieloma múltiplo recidivado ou refratário O objetivo primário do estudo MajesTEC-1 era TRG, que foi de 63%, com 39,4% RC ou melhor. Destes, a taxa de DRM foi 46% #mieloma @scheinbp @morenodegusmao https://t.co/YekfS05fRp (Twitter) - Apr 29, 2023
- | Tecvayli (teclistamab) / Genmab, J&J
Journal, Real-world evidence, Real-world: Teclistamab versus real-world physician's choice of therapy in triple-class exposed relapsed/refractory multiple myeloma. (Pubmed Central) - Apr 28, 2023
Trial completion date: Aug 2025 --> May 2025 Teclistamab
- || Review, Journal, IO biomarker: Antibody-Drug Conjugates for Multiple Myeloma: Just the Beginning, or the Beginning of the End? (Pubmed Central) - Apr 28, 2023
Most recently, the bispecific anti-BCMA and T-cell-engaging antibody teclistamab has become available, again for patients with relapsed/refractory disease...However, belantamab remains a drug with some promise, and many other ADCs targeting either BCMA or other plasma cell surface markers are in development and showing potential. This contribution will provide an overview of some of the current data supporting the possibility that ADCs will remain a part of our chemotherapeutic armamentarium against myeloma moving forward, and also highlight areas for future development.
- Sequencing bispecific antibodies and CAR T cell therapy in multiple myeloma with prior exposure to BCMA-targeted therapies. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6254;
Longer follow up and larger studies are needed to further evaluate their enhanced benefit and generate greater insight for optimal sequencing strategies in heavily pretreated MM patients who have exhausted other options. >
- Tecvayli (teclistamab) / Genmab, J&J
Efficacy of teclistamab in patients (pts) with heavily pretreated, relapsed/refractory multiple myeloma (RRMM), including those refractory to penta RRMM and BCMA (B-cell maturation antigen) directed therapy (BDT). () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6251;
Overall, teclistamab was well tolerated with no major safety events. Keywords: Plasma cell disorders, relapsed multiple myeloma, Penta-class refractory myeloma, BCMA directed therapy.
- Xpovio (selinexor) / Karyopharm, Menarini, FORUS Therap
Effectiveness of anti-B-cell maturation antigen (BCMA)-targeting therapy after selinexor treatment. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6241;
P1b/2, P2b
In this cohort of heavily-pretreated pts with MM who received a selinexor regimen prior to NCA, overall survival was in the range of 1 year, akin to historical results seen with ADCs. The 8-week median time between administration of selinexor and NCAs suggests that selinexor, with various partner agents, did not negatively impact overall survival with subsequent NCA therapy.
- Outpatient practice utilization for CAR-T and T cell engager in patients with lymphoma and multiple myeloma. (On Demand | Hall A; Poster Bd # 127) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1483;
Approximately 31% of pts were admitted after 3 days from CAR-T infusion, and 27% of our pts were never admitted. Variables associated with aggressive disease can predict early hospitalization in pts receiving FDA-approved CAR-T.
- Tecvayli (teclistamab) / Genmab, J&J
Long-term follow-up from MajesTEC-1 of teclistamab, a B-cell maturation antigen (BCMA) x CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma (RRMM). (On Demand | E450; Poster Bd # 3) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1431;
P1, P2
Variables associated with aggressive disease can predict early hospitalization in pts receiving FDA-approved CAR-T. Pts had a median of 5 prior LOT (range, 2
- Tecvayli (teclistamab) / Genmab, J&J
MajesTEC-9: A randomized phase 3 study of teclistamab versus pomalidomide, bortezomib, and dexamethasone or carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma. (On Demand | Hall A; Poster Bd # 57a) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1424;
P3
The study opened in January 2023 and enrollment is ongoing. Clinical trial information: NCT05572515.
- Tecvayli (teclistamab) / Genmab, J&J
Evaluating the efficacy of commercial teclistamab in relapsed refractory multiple myeloma patients with prior exposure to anti-BCMA therapies. (Available On Demand; Poster Bd # 41) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1407;
Tec remains effective in RRMM despite prior exposure to anti-BCMA therapies, though exposure to multiple prior anti-BCMA therapies may be predictive of diminished efficacy. Clinical data on additional patients will be presented at the meeting.
- Tecvayli (teclistamab) / Genmab, J&J
Durability of responses with biweekly dosing of teclistamab in patients with relapsed/refractory multiple myeloma achieving a clinical response in the majesTEC-1 study. (On Demand | Hall A; Poster Bd # 26) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1392;
P1, P2
Overall, patients from the MajesTEC-1 study who transitioned from QW to less frequent Q2W dosing of teclistamab had sustained remission, with a median duration of response of 20.5 months from the date of switch. Clinical trial information: NCT03145181, NCT04557098.
- Actemra IV (tocilizumab) / Roche, JW Pharma, Tecvayli (teclistamab) / Genmab, J&J
Evaluation of prophylactic tocilizumab (toci) for the reduction of cytokine release syndrome (CRS) to inform the management of patients (pts) treated with teclistamab in MajesTEC-1. (On Demand | Hall A; Poster Bd # 25) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1391;
P1, P2
Prophylactic toci has the potential to reduce CRS risk in pts with disease profiles suitable for outpatient dosing, reducing the burden of hospitalization during teclistamab step-up dosing. Clinical trial information: NCT03145181, NCT04557098.
- Tecvayli (teclistamab) / Genmab, J&J, talquetamab (JNJ-64407564) / J&J
First results from the RedirecTT-1 study with teclistamab (tec) + talquetamab (tal) simultaneously targeting BCMA and GPRC5D in patients (pts) with relapsed/refractory multiple myeloma (RRMM). (Live Stream | Hall D2) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1369;
P1b
A 92% ORR was observed in pts with advanced RRMM at the RP2R, and an ORR of 83% was achieved in pts with EMD, a high-risk population with unmet need, supporting further evaluation of the combination. Clinical trial information: NCT04586426.
- ||| Tecvayli (teclistamab) / Genmab, J&J, Carvykti (ciltacabtagene autoleucel) / J&J
Clinical: I completely disagree with Dr Auclair. Just had a patient who cant get Cilta-cel due to limited allocation and there are centers running CiltaCel and Teclistamab trials in precursor conditions! When will people think in large scale? (Twitter) - Apr 20, 2023
- Tecvayli (teclistamab) / Genmab, J&J
PRELIMINARY RECOMMENDATIONS FOR PREVENTION AND MANAGEMENT OF INFECTIONS, HYPOGAMMAGLOBULINEMIA, AND NEUTROPENIA DURING TREATMENT WITH TECLISTAMAB BASED ON EXPERIENCE FROM THE MAJESTEC-1 STUDY () - Apr 20, 2023 - Abstract #COMy2023COMy_195;
- Tecvayli (teclistamab) / Genmab, J&J
EXPERIENCE WITH TECLISTAMAB IN REFRACTORY MULTIPLE MYELOMA IN A SINGLE CENTER () - Apr 20, 2023 - Abstract #COMy2023COMy_183;
- Tecvayli (teclistamab) / Genmab, J&J, Darzalex Faspro (daratumumab/hyaluronidase) / J&J
TECLISTAMAB IN COMBINATION WITH SUBCUTANEOUS DARATUMUMAB AND LENALIDOMIDE IN PATIENTS WITH MULTIPLE MYELOMA: RESULTS FROM ONE COHORT OF MAJESTEC-2, A PHASE 1B, MULTICOHORT STUDY (Online) - Apr 20, 2023 - Abstract #COMy2023COMy_167;
- Tecvayli (teclistamab) / Genmab, J&J
MAJESTEC-1: CORRELATIVE ANALYSES OF TECLISTAMAB, A B-CELL MATURATION ANTIGEN X CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (Online) - Apr 20, 2023 - Abstract #COMy2023COMy_165;
- ||| Tecvayli (teclistamab) / Genmab, J&J
This was topic of discussion #iwCART23 with evolving #CART slot availability and now Teclistamab approval as well #mmsm @Rfonsi1 @DrKrinaPatel Doris Hansen @ESmithMDPhD Sham Mailankody @MayoCancerCare @MSKCancerCenter @MDAndersonNews (Twitter) - Apr 16, 2023
- | Tecvayli (teclistamab-cqyv) / Genmab, J&J
Trial completion date, IO biomarker: MajesTEC-1: Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Apr 13, 2023
P1, N=282, Recruiting, Sponsor: Janssen Research & Development, LLC
Clinical trial information: NCT04586426. Trial completion date: Jan 2025 --> Aug 2025
- ||| Tecvayli (teclistamab) / Genmab, J&J
Biopsy: My wife had CAR-T. At the 90 day bone marrow biopsy, the disease was just as bad as when she began, though it had been better at the 30 day mark. They put her on Elo and she got 5 months out of Elo. Now doing very well on teclistamab. (Twitter) - Apr 11, 2023
- ||| Tecvayli (teclistamab) / Genmab, J&J
Clinical: Are you doing same outpatient procedure/protocol for Teclistamab too? (Twitter) - Apr 11, 2023
- || Tecvayli (teclistamab) / Genmab, J&J
I don't see Dara KRD + teclistimab + seli deficiency as an option (Twitter) - Apr 11, 2023
- ||||| Tecvayli (teclistamab) / Genmab, J&J
Clinical: Teclistamab was the 1st bispecific antibody approved by the @US_FDA for R/R multiple myeloma, & other agents in this class that are under development could represent additional treatment options for this patient population. @Amyloid_Planet @karmanoscancer https://t.co/mSPkzzqDuq (Twitter) - Apr 10, 2023
- |||| Tecvayli (teclistamab) / Genmab, J&J
Great deep dive by @TomBmt133 @AjayNookaMD et al into CRS with teclistamab #MMsm in MajesTEC-1. Of course some confounders, but preemptive toci for Gr1 CRS seemed to ⬇️ recurrence. When it comes to the Shakespearean question "Toci or not toci?", my answer is generally "Toci"! https://t.co/WCWS2oaZMC (Twitter) - Apr 8, 2023
- || Tecvayli (teclistamab) / Genmab, J&J
Now that teclistamab has been out a while, how are you giving step up doses? @RahulBanerjeeMD @VictoriaNachar @ManniMD1 @RBeechPharmD @kczmj @katmapes @DucoPharmD @Arpita_GandhiRX @KPsiBCOP @KPetersonPharmD @CWagnerPharmD @DrKrinaPatel @erin_eberwein @PharmDeetinib (Twitter) - Apr 4, 2023
- Tecvayli (teclistamab) / Genmab, J&J
MAJESTEC-1: CORRELATIVE ANALYSES OF TECLISTAMAB, A B-CELL MATURATION ANTIGEN (BCMA) X CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM) (Poster Area) - Apr 4, 2023 - Abstract #EMN2023EMN_177;
Trial completion date: Jan 2025 --> Aug 2025 Baseline correlative analysis for pivotal RP2D pts suggests emerging profile for nonresponders of unfavorable baseline immune characteristics, including lower T cell numbers, higher baseline T cells expressing PD-1, TIM-3, CD38, increased Tregs and CD38+ Tregs, and lower proportion of na
- Tecvayli (teclistamab) / Genmab, J&J, Darzalex Faspro (daratumumab/hyaluronidase) / J&J
SINGLE COHORT RESULTS FROM MAJESTEC-2: TECLISTAMAB (TEC) IN COMBINATION WITH SUBCUTANEOUS DARATUMUMAB (DARA) AND LENALIDOMIDE (LEN) IN PATIENTS WITH MULTIPLE MYELOMA (MM) (Poster Area) - Apr 4, 2023 - Abstract #EMN2023EMN_175;
P1b
Promising ORR findings support the potential of combined treatment on enhanced early disease control through the addition of tec. The phase 3 MajesTEC-7 study will compare TEC-DARA-LEN vs the combination of DARA, LEN, and dexamethasone in pts with NDMM ineligible or not intended for autologous stem cell transplant as initial treatment.
- |||| Tecvayli (teclistamab) / Genmab, J&J
Clinical: Agree Murali. For docs in the US, this trial prompts soul searching. If one believes in first PFS, is dara/len/dex enough for a fit/young patient? Conversely, if someone truly is transplant ineligible/frail, is dara/len/dex and teclistamab a good idea? Fails both sets of pts. (Twitter) - Mar 28, 2023
- || Tecvayli (teclistamab) / Genmab, J&J, Talvey (talquetamab) / J&J
Enrollment change, Trial completion date: RedirecTT-1: A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Mar 27, 2023
P1b, N=164, Recruiting, Sponsor: Janssen Research & Development, LLC
The phase 3 MajesTEC-7 study will compare TEC-DARA-LEN vs the combination of DARA, LEN, and dexamethasone in pts with NDMM ineligible or not intended for autologous stem cell transplant as initial treatment. N=102 --> 164 | Trial completion date: Feb 2025 --> Mar 2024
- ||| Tecvayli (teclistamab) / Genmab, J&J
The latest The Multiple Myeloma Daily! https://t.co/jDZYqYSUMi Thanks to @TargetedOnc #mmsm #teclistamab (Twitter) - Mar 26, 2023
- |||||| Tecvayli (teclistamab) / Genmab, J&J
Clinical: Rafael Fonseca, MD, discusses the efficacy and safety with #teclistamab for patients with relapsed/refractory #multiplemyeloma. #mmsm | @MayoClinic @Rfonsi1 https://t.co/BXQbWLA7SI (Twitter) - Mar 26, 2023
- ||| Tecvayli (teclistamab) / Genmab, J&J
For Oncologists: a 76 y/o Pt with RRMM, Penta Class RRMM, post CAR-T; started on weekly Teclistamab; pt achieved sCR, due to concerns of risk of infection what will you do?#mmsm #myeloma #USMIRC #MedTwitter (Twitter) - Mar 25, 2023
- |||| Tecvayli (teclistamab) / Genmab, J&J
Clinical, Metastases: Bispecific antibodies like #teclistamab have yielded encouraging outcomes for pts w/ advanced #MultipleMyeloma. But can the toxicities & questions of optimal sequencing be safely addressed? @JanakiramMurali & @DoctorAKrishnan discuss: https://t.co/iD274oMLqU #mmsm #ASCODailyNews (Twitter) - Mar 24, 2023