American Society of Clinical Oncology (ASCO) Annual Meeting | Chicago | 2026
- Badari Andukuri
- May 30
- 20 min read
Updated: 6 days ago
ASTRAZENECA
STRIDE Plus Lenvatinib and TACE Cuts Progression Risk by 30% in Embolisation‑Eligible Unresectable HCC
Early EMERALD‑3 results indicate that combining dual checkpoint blockade and lenvatinib with TACE can prolong disease control in patients with embolisation‑eligible, unresectable hepatocellular carcinoma, without introducing new safety concerns.
How EMERALD‑3 was designed?
EMERALD‑3 is a Phase III study enrolling people with unresectable HCC who are suitable for transarterial chemoembolisation. The trial compares standard TACE alone with two systemic‑plus‑locoregional strategies built on a STRIDE backbone, in which a single priming dose of tremelimumab is followed by durvalumab at regular intervals. One experimental arm adds both STRIDE and lenvatinib to TACE, and the other combines STRIDE with TACE without lenvatinib.
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What the trial showed for time to progression?
At the time of the planned interim analysis, the regimen that layered STRIDE, lenvatinib and TACE reduced the risk of radiographic progression or death by about 30% compared with TACE alone
This translated into a median progression‑free survival of 13.0 months for the triple‑therapy group, versus 9.8 months for patients who received only TACE.
The second investigational arm, which paired STRIDE with TACE but did not include lenvatinib, also produced a clear separation in time to progression.
Median PFS reached 12.9 months with STRIDE plus TACE, compared with 8.1 months in its TACE‑alone control arm.
Together, these data show that both STRIDE‑based strategies extended time to progression beyond what is typically expected with embolisation alone.
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First look at overall survival
Overall survival is still maturing, but the initial signal points in the same direction as the PFS data.
In the group treated with STRIDE, lenvatinib and TACE, median OS was 39.5 months versus 34.7 months for the corresponding TACE‑alone group, suggesting a trend toward longer survival that will need confirmation with additional follow‑up.
For patients who received STRIDE plus TACE without lenvatinib, median OS had not yet been reached at this analysis, whereas the TACE‑only comparator arm had a median OS of 32.9 months.
Why this matters for embolisation‑eligible HCC
EMERALD‑3 is one of the first large randomized trials to show that integrating systemic immunotherapy, with or without a tyrosine kinase inhibitor, around the time of TACE can meaningfully lengthen the period before progression compared with TACE alone, with early survival data that favour the combination approaches.
From a safety standpoint, the combinations behaved largely as expected. The pattern and types of adverse events were consistent with the known profiles of durvalumab, tremelimumab, lenvatinib and TACE.
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Camizestrant Switch Strategy Reshapes First‑Line Care in ESR1‑Mutated HR‑Positive Advanced Breast Cancer
Camizestrant was evaluated in the Phase 3 SERENA-6 trial in patients with hormone receptor-positive, HER2-negative advanced breast cancer who were receiving first‑line treatment with an aromatase inhibitor (anastrozole or letrozole) plus a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib).
In the SERENA-6 trial, patients with HR+/HER2-advanced breast cancer who acquired an ESR1 mutation during first-line treatment with an aromatase inhibitor (AI) and a CDK4/6 inhibitor were randomized to either replace the AI with camizestrant or maintain their existing regimen.
Transitioning to camizestrant yielded a 55% reduction in the risk of disease progression or death, extending median progression-free survival (PFS) to 16.8 months compared to 9.2 months in the control group. Additionally, the investigational regimen delayed subsequent disease progression, lowering the risk of PFS2 or death by 37%, with a median PFS2 of 25.7 months versus 19.1 months for continued AI therapy.
Key SERENA-6 figures for summary use:
PFS: 16.8 months (camizestrant + CDK4/6 inhibitor) vs 9.2 months (AI + CDK4/6 inhibitor)
PFS2: 25.7 months (camizestrant + CDK4/6 inhibitor) vs 19.1 months (AI + CDK4/6 inhibitor)
ELI LILLY
Eli Lilly's Retevmo Shows Strong Benefit As Adjuvant Therapy In Early RET Fusion-Positive Lung Cancer
Eli Lilly has reported positive Phase 3 results from the LIBRETTO 432 trial, which tested Retevmo (selpercatinib) as adjuvant treatment compared with placebo in people with early stage RET fusion positive non small cell lung cancer. The study met its primary goal, with investigator assessed event free survival significantly improved and selpercatinib lowering the risk of disease recurrence or death by 83 percent in the main analysis group of patients.
Findings from LIBRETTO 432 position RET fusions alongside EGFR mutations and ALK rearrangements as important biomarkers in early stage lung cancer that can identify patients who may derive substantial benefit from targeted adjuvant therapy, reinforcing the need for comprehensive molecular testing at diagnosis across stages. LIB
RETTO 432 is the first randomized Phase 3 study to specifically assess a selective RET inhibitor in the adjuvant setting for this population. The trial enrolled 151 participants, who were assigned in a one to one ratio to receive selpercatinib 160 mg twice daily or placebo for up to three years after completion of curative intent surgery or definitive radiotherapy, with or without prior adjuvant chemotherapy.
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At a median follow up of 24 months, event free survival in the primary analysis cohort, which included patients with stage II to IIIA disease (n=109), was markedly improved with selpercatinib compared with placebo. The 24 month event free survival rate was 92 percent in the selpercatinib arm versus 61 percent in the placebo arm. Median event free survival had not yet been reached for selpercatinib, while it was 31.8 months for placebo.
In the full study population, results were consistent and again favored selpercatinib, with a 24 month event free survival rate of 94 percent with selpercatinib versus 70 percent with placebo.
The safety profile seen with selpercatinib in LIBRETTO 432 was broadly in line with earlier studies from the selpercatinib clinical development program.
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Retevmo and its mechanism of action
Retevmo (selpercatinib, previously known as LOXO 292) is an oral, highly selective RET kinase inhibitor with demonstrated activity in the central nervous system. As a targeted therapy, it can influence both malignant and healthy cells, which can lead to adverse effects that require monitoring and management. RET driven alterations usually occur independently of other oncogenic drivers, making RET a distinct and actionable target in this molecular subset.
JOHNSON AND JOHNSON
J&J’s Rybrevant + Lazcluze Regimen Shows Survival Extension in Atypical EGFR Non-Small Cell Lung Cancer
Johnson & Johnson’s presented Phase 1/1b CHRYSALIS-2 study, demonstrating a substantial survival advantage for patients with advanced non-small cell lung cancer (NSCLC) presenting with uncommon EGFR mutations.
Frontline treatment with the combination of Rybrevant (amivantamab) and Lazcluze (lazertinib) yielded a median overall survival (mOS) of 41.0 months.
This secondary endpoint milestone builds upon earlier data from the trial, which had already met its primary objective by establishing an objective response rate (ORR) of 57%.
Collectively, these insights reinforce the dual-therapy regimen as a highly viable first-line intervention across the broader spectrum of EGFR-mutated advanced NSCLC, offering classic and atypical subgroups alike a path toward prolonged survival.
Patients whose tumors express atypical EGFR variants face a traditionally poor prognosis relative to individuals with common alterations like L858R mutations or exon 19 deletions. Comprising roughly 10% to 20% of all EGFR-mutated NSCLC diagnoses, this subpopulation has long suffered from a scarcity of durable frontline interventions.
Monotherapy protocols typically result in a median overall survival of under 24 months, highlighting a critical therapeutic deficit.
Rybrevant addresses this gap through its unique design, which concurrently blocks the EGFR and MET pathways while stimulating an immune response, dual mechanisms that explicitly counter tumor replication and conventional treatment resistance.
Tecvayli Shows Improved Survival Outcomes from Early Relapse in Multiple Myeloma
Johnson and Johnson has presented new findings from the Phase 3 MajesTEC-9 trial highlighting significant clinical benefits of Tecvayli (teclistamab) compared with commonly used treatment regimens in patients with relapsed or refractory multiple myeloma, including those treated as early as second line. In this study population, where most patients were resistant to both anti-CD38 therapies and lenalidomide,
Tecvayli lowered the risk of disease progression or death by 71 percent and reduced the risk of death by 40 percent.
MajesTEC-9 Trial Findings
The MajesTEC-9 trial compared Tecvayli, a bispecific antibody that engages T cells, with standard treatment options including pomalidomide combined with bortezomib and dexamethasone, or carfilzomib with dexamethasone. The study included patients with relapsed or refractory multiple myeloma who had received between one and three prior treatment lines, including lenalidomide and a CD38-targeting monoclonal antibody.
Clinical benefit was observed across a heavily pretreated group. A large proportion of participants were resistant to anti-CD38 therapies (85 percent) and lenalidomide (79 percent), and more than 90 percent had disease that did not respond to their most recent therapy.
Treatment with Tecvayli led to a 71 percent decrease in the risk of disease progression or death, and a 40 percent reduction in mortality risk, when compared with standard care.
Secondary outcomes also favored Tecvayli, including response rates. Nearly 66 percent of patients receiving Tecvayli achieved a complete response or better, compared with about 17 percent in the standard treatment group, indicating deeper and more durable responses.
The safety findings for Tecvayli in this trial were consistent with previously reported data, with no unexpected safety concerns identified.
PFIZER
Lorbrena Establishes Long-Term Efficacy Benchmark in ALK+ NSCLC Following 7-Year CROWN Data
An astounding 55% of treatment-naive, ALK-positive advanced non-small cell lung cancer (NSCLC) patients remain alive and progression-free after seven years on Lorbrena (lorlatinib).
This mature milestone comes from Pfizer’s Phase 3 CROWN trial, which directly pitted the third-generation ALK inhibitor (available in Europe as Lorviqua) against the first-generation standard, Xalkori (crizotinib).
By comparison, only 3% of the Xalkori cohort achieved the same progression-free milestone at the seven-year mark.
According to the latest data, Lorbrena cut the risk of disease progression or mortality by 81% compared to its predecessor.
Because the drug continues to show such sustained efficacy, the median progression-free survival (PFS) for patients on Lorbrena has still not been reached.
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About the Phase 3 CROWN Design
The open-label, randomized trial tracked 296 previously untreated patients split evenly into two single-agent arms: Lorbrena (n=149) and Xalkori (n=147).While the study's primary objective was to track PFS via blinded independent central review, secondary clinical markers include:
Overall survival (OS), which is still immature and under ongoing observation.
Objective response rate (ORR) and safety.
Intracranial response tracking.
Because Lorbrena’s median PFS remained unreached during earlier three- and five-year analyses, investigators initiated exploratory follow-ups to map out these long-term survival curves. This seven-year update marks one of the most durable progression-free survival outcomes ever recorded in advanced lung cancer therapy.
BMS
Targeted Protein Degrader Mezigdomide Demonstrates Strong Efficacy in Heavily Pretreated Relapsed or Refractory Myeloma Patients
Bristol Myers Squibb reported encouraging findings showing that the CELMoD candidate Mezigdomide reduced the likelihood of disease progression or death by more than half compared with standard therapy in patients with relapsed or refractory multiple myeloma.
Data from the Phase 3 Successor-2 study highlight the potential of CELMoD-based treatments to significantly improve clinical outcomes in this patient population.
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The company presented late-stage results from the Phase 3 Successor-2 trial evaluating Mezigdomide in combination with Carfilzomib and Dexamethasone, referred to as MeziKd, compared with Carfilzomib and Dexamethasone alone.
The combination regimen demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, with a median duration of 18 months versus 8.3 months in the control arm. This corresponds to a 52 percent reduction in the risk of disease progression or death.
The benefits of MeziKd were consistent across multiple patient groups, including those receiving second- and third-line treatments and individuals with high-risk disease characteristics. The overall response rate was notably higher in the MeziKd arm at 80.2 percent compared to 53.4 percent with standard therapy. Additionally, complete response or better was achieved in 26.7 percent of patients receiving MeziKd, versus 8.9 percent in the comparator group. Median overall survival data remain immature at this stage.
The safety findings aligned with the established profile of Mezigdomide and the combination regimen.
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About the Successor-2 Study
An increasing number of patients with multiple myeloma become resistant to Lenalidomide and anti-CD38 therapies early in their treatment course, creating a need for new therapeutic options. The Successor-2 trial was designed to address this gap.
This study is a randomized, open-label, multicenter Phase 2/3 trial assessing both efficacy and safety of Mezigdomide combined with Carfilzomib and Dexamethasone versus the standard combination alone in patients with relapsed or refractory multiple myeloma.
The primary endpoint for the Phase 3 portion is progression-free survival. Secondary measures include overall survival, response rates, duration of response, time to disease progression, time to subsequent therapy, minimal residual disease negativity, and patient-reported quality of life.
What is mezigdomide and what is mechanism of action of mezigdomide?
Mezigdomide is an orally administered CELMoD agent developed through Bristol Myers Squibb’s targeted protein degradation platform. It is engineered to rapidly and effectively degrade key transcription factors, including Ikaros and Aiolos, which play a role in multiple myeloma cell survival.
Preclinical findings indicate that Mezigdomide can enhance T cell activity and help restore immune function that has become ineffective. Ongoing Phase 3 trials, including Successor-1 and Successor-2, are evaluating Mezigdomide-based oral combinations against current standard treatments in relapsed or refractory multiple myeloma.
Izalontamab Brengitecan Improves Survival in Triple‑Negative Breast Cancer and Esophageal Squamous Cell Carcinoma
Izalontamab brengitecan is emerging as a versatile late‑stage ADC, with new Phase 3 readouts showing survival advantages in two difficult‑to‑treat solid tumours: triple‑negative breast cancer and esophageal squamous cell carcinoma.
Triple‑negative breast cancer: Phase 3 PANKU‑Breast02
PANKU‑Breast02 enrolled patients with unresectable, locally advanced or metastatic triple‑negative breast cancer whose disease had progressed after one or two prior systemic regimens for advanced disease, including a taxane. Participants were randomized to receive either izalontamab brengitecan or a physician‑selected single‑agent chemotherapy (eribulin, capecitabine, gemcitabine or vinorelbine).
At the planned interim analysis, the bispecific ADC improved both of the trial’s primary endpoints.
Median overall survival was 15.9 months in the izalontamab brengitecan arm versus 12.5 months in the chemotherapy arm, after a median of 11 months of follow‑up
Progression‑free survival by blinded independent central review showed an even larger separation: 8.5 months with izalontamab brengitecan compared with 3.1 months with physician’s choice
Tumour shrinkage rates also favored the investigational treatment. The centrally confirmed objective response rate reached 51.7% for izalontamab brengitecan versus 20.5% for standard chemotherapy, with an odds ratio of 4.3, indicating more than a fourfold higher likelihood of response.
Esophageal squamous cell carcinoma: Phase 3 PANKU‑Esophagus01
PANKU‑Esophagus01 focused on a different high‑need setting: recurrent or metastatic esophageal squamous cell carcinoma following progression on first‑line therapy containing a PD‑1/PD‑L1 inhibitor plus platinum‑based chemotherapy. In this study, patients were assigned to izalontamab brengitecan or to the treating physician’s choice of chemotherapy.
Here too, both primary endpoints were met at interim analysis.
Overall survival improved from 7.2 months with chemotherapy to 9.8 months with izalontamab brengitecan
Median progression‑free survival by central review doubled from 2.0 months in the control arm to 4.2 months in the ADC arm
Response data support these survival gains.
Objective responses were observed in 35.3% of patients treated with izalontamab brengitecan, compared with 13.1% in those receiving chemotherapy alone, confirming meaningful antitumour activity after chemo‑immunotherapy failure.
With positive findings now reported from three Phase 3 studies, izalontamab brengitecan is beginning to look like a broadly active platform across multiple epithelial cancers rather than a niche ADC.
Izalontamab Brengitecan mechanism of action: dual targeting plus DNA‑damaging payload
Izalontamab brengitecan (BL‑B01D1) is built as a bispecific antibody–drug conjugate directed against two receptor tyrosine kinases, EGFR and HER3. These receptors are commonly overexpressed in a range of epithelial tumours and help drive signalling networks that support tumour proliferation, survival and therapeutic resistance. By binding both EGFR and HER3, the antibody simultaneously interferes with two key signalling nodes on the cancer cell surface, aiming to weaken growth and survival pathways.
BEONE
BeOne Medicines Sets New Industry Standard for Long-Term CLL Management with Extended Zanubrutinib Results
BeOne Medicines has established a definitive benchmark for lasting disease control in chronic lymphocytic leukemia (CLL) following a 78-month analysis of its zanubrutinib program. This observation window stands as the longest ever recorded for a next-generation Bruton’s tyrosine kinase (BTK) inhibitor in this therapeutic area.
These updated findings confirm that zanubrutinib provides enduring clinical advantages that persist well beyond the initial phase of therapy. Furthermore, the combination of zanubrutinib with the novel BCL2 inhibitor sonrotoclax is achieving exceptionally rapid and deep rates of undetectable minimal residual disease (uMRD), offering a promising framework for time-limited CLL treatment regimens.
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SEQUOIA Trial Update Confirms Sustained Long-Term Efficacy
The SEQUOIA investigation now represents the most comprehensive follow-up study for a next-generation BTK inhibitor in frontline CLL management. After a median observation period of 84.01 months (ranging from 0.0 to 101.5), zanubrutinib demonstrated superior performance compared to the traditional regimen of bendamustine and rituximab (BR) in individuals with previously untreated CLL/SLL.
Primary progression-free survival (PFS) metrics at the 78-month mark include:
Overall PFS: 71.8% for zanubrutinib compared to 31.0% for the BR group.
Unmutated IGHV Population: 70.4% with zanubrutinib versus 17.4% for those on BR.
Mutated IGHV Population: 81.8% for zanubrutinib compared to 45.1% for the BR group.
Data regarding disease control following initial progression also favored the zanubrutinib arm:
78-Month PFS2: 81.3% for zanubrutinib versus 74.4% for the BR regimen.
78-Month COVID-Adjusted PFS2: 84.7% for zanubrutinib against 76.4% for the BR group.
Among the 241 patients initially treated with zanubrutinib, 26 experienced progression; notably, half of those individuals utilized subsequent BCL2 inhibitor-based salvage options, and 69.2% remained free of progression after more than three additional years of monitoring. The time elapsed before requiring secondary treatment was also significantly improved for those on zanubrutinib. The safety profile remained aligned with previous findings, revealing no emerging concerns.
Real-World Evidence Highlights Clinical Edge in Diverse Populations
Three major real-world studies, aggregating data from over 250,000 patients, support the role of zanubrutinib as a best-in-class BTK inhibitor with consistent safety and efficacy profiles.
Medicare Database Review: Among 10,523 frontline CLL/SLL patients, those administered zanubrutinib experienced a statistically significant reduction in risks related to mortality, the necessity for next-line intervention, or treatment cessation when compared to individuals treated with ibrutinib or acalabrutinib
Komodo Database Assessment: In a study of 16,788 patients with treatment-naive CLL, zanubrutinib was linked to a more favorable duration before the next therapy requirement and improved overall survival
Retrospective Safety Analysis: A review of 233,362 newly diagnosed patients initiating BTK inhibitors showed the lowest one-year rate of atrial fibrillation among those treated with zanubrutinib (11%) compared to 13% for acalabrutinib and 16% for ibrutinib
Rapid, Deep Responses with Zanubrutinib and Sonrotoclax
A Phase I/1b study evaluating treatment-naive CLL/SLL patients, with a median follow-up of approximately 34 months, showed that the all-oral combination of zanubrutinib and sonrotoclax achieved unmatched rates and speed of undetectable minimal residual disease, even in high-risk patient subgroups.
Key efficacy metrics include:
Overall Response Rate (ORR): 100%.
Complete Response Rate: 59.5%.
Optimal uMRD4 Achievement: 98.8%.
TP53/del(17p) Population uMRD: 92.9% across two distinct dosage levels.
Median Time to uMRD4: 4.5 months.
What is the mechanism of action of zanubrutinib?
A precision-engineered, oral small molecule designed for total and sustained inhibition of Bruton's tyrosine kinase via optimized selectivity and bioavailability. With the most expansive global labeling of any BTK inhibitor, it remains the only agent in its category proven superior to a competitor in a Phase III trial. It has been utilized by over 290,000 patients in 80 markets.
What is the mechanism of action of Sonrotoclax?
A potent, next-generation BCL2 inhibitor characterized by a short half-life and the absence of drug accumulation. It is authorized in the U.S. and China for relapsed/refractory mantle cell lymphoma and holds specific approvals in China for previously treated CLL/SLL.
What is the mechanism of action of Tacabrutideg?
A potential first-in-class oral BTK degrader currently being evaluated in an extensive global program, including three Phase III trials for relapsed/refractory CLL. It utilizes a novel platform to break down both wildtype and mutated BTK proteins, effectively addressing resistance. It has received FDA Fast Track designation and EMA PRIME status for select indications.
Phase 3 HERIZON-GEA-01 trial show that substituting standard trastuzumab with the HER2-targeted bispecific antibody ZIIHERA, combined with chemotherapy, with or without the anti-PD-1 antibody TEVIMBRA, extends survival in previously untreated patients
Core Efficacy Metrics: Survival, Progression, and Response
The trial evaluated the clinical impact of Ziihera (zanidatamab)-based combinations against the standard control regimen (trastuzumab plus chemotherapy).
Median Overall Survival (mOS): Patients receiving the triple combination of Ziihera, Tevimbra(tislelizumab), and chemotherapy achieved a median overall survival of 26.4 months, demonstrating a statistically robust and clinically meaningful advantage. Those treated with Ziiheraand chemotherapy alone reached a median overall survival of 24.4 months, while the control group recorded 19.2 months.
Median Progression-Free Survival (mPFS): Progression-free survival was also notably extended in both Ziihera-based treatment arms, with a median duration of 12.4 months, indicating consistent disease control compared to the control regimen.
Median Duration of Response (mDoR): The durability of response further supported these findings. Patients treated with the triple combination experienced a median duration of response of 20.7 months. In comparison, Ziihera plus chemotherapy achieved 14.3 months, while the control arm showed a shorter duration of 8.3 months.
ASCO 2026 Presentation Highlights Efficacy Across Subgroups
Following a median observation period of 26 months, the combination of Ziihera,
Tevimbra, and chemotherapy produced meaningful extensions in both progression-free and overall survival for individuals with PD-L1-positive as well as PD-L1-negative malignancies when evaluated against the control group; these clinical outcomes showed strong alignment across both the tumor area positivity (TAP) and combined positive score (CPS) quantification methodologies.
Among individuals classified under the TAP <1% and TAP ≥1% thresholds, the 18-month progression-free survival rates reached 50.3% and 42.6%, respectively, while the corresponding 24-month overall survival rates were recorded at 63.7% and 53.5% within the triple-therapy cohort.
For the PD-L1-negative group (TAP <1%), median overall survival extended to 29.7 months with the Ziihera, Tevimbra, and chemotherapy protocol, compared to 15.8 months for those assigned to the control protocol. Conversely, for the PD-L1-positive group (TAP ≥1%), median overall survival reached 26.4 months using the ZIIHERA, TEVIMBRA, and chemotherapy protocol, versus 21.2 months within the standard-of-care cohort. These observations remained uniform irrespective of the specific PD-L1 testing system employed.
In the TAP <1% subset, the combination of Ziihera, Tevimbra, and chemotherapy demonstrated a median progression-free survival of 18.5 months compared to 7.9 months in the control cohort, whereas in the TAP ≥1% population, the median progression-free survival was 11.3 months versus 8.3 months in the comparative control arm.
SUN PHARMA
Unloxcyt Shows 50% Response and Durable Remissions in Locally Advanced Cutaneous Squamous Cell Carcinoma
Long-term follow-up from the CK-301-101 trial demonstrates that Unloxcyt (cosibelimab) provides sustained clinical benefits for patients with locally advanced cutaneous squamous cell carcinoma (laCSCC). The data, presented by Sun Pharma, highlights a favorable safety profile with notably low rates of severe immune-related toxicity.
Clinical Efficacy in laCSCC
The study involved 64 adults (median age 77) receiving at least one dose. This cohort’s demographics, primarily male, align with real-world clinical observations for this disease.
Treatment Duration: Patients received a median of 29 doses over approximately 60 weeks.
Objective Response Rate (ORR): 50% of the cohort responded to treatment.
Complete Response (CR): 27%
Partial Response (PR): 23%
Durability: At a median follow-up of 31 months, the median duration of response (DOR) remained unreached, indicating long-term disease control.
Safety and Tolerability Profile
The updated safety data remains consistent with earlier smaller-scale analyses and current labeling.
Immune-Related Adverse Events (irAEs): While roughly 33% of patients experienced an irAE, high-grade toxicity was rare.
Severity: Only one patient (less than 2%) reported a Grade 3 or higher treatment-related dermatologic event.
General Toxicity: Treatment-emergent adverse events (TEAEs) were frequent but manageable; notably, no fatalities were linked to the treatment.
With a 50% response rate and nearly 3 years of follow-up, Unloxcyt maintains a robust efficacy-to-safety ratio, characterized by deep, durable responses and minimal high-grade immune complications.
REGENERON
Lynozyfic (Linvoseltamab) Shows 100% Response and Rapid Deep Remissions in Second‑Line Systemic AL Amyloidosis
What is its mechanism of action of Lynozyfic (linvoseltamab) ?
Linvoseltamab is a human BCMA×CD3 bispecific antibody designed to link B‑cell maturation antigen (BCMA) on abnormal plasma cells with CD3 on T cells, activating the immune system to attack and eliminate the disease‑driving plasma cells. It is already used in specific settings for adults with relapsed or refractory multiple myeloma and is now being investigated as a fixed‑duration monotherapy in systemic AL amyloidosis beyond the first line of treatment.
By binding BCMA on clonal plasma cells and CD3 on cytotoxic T cells, linvoseltamab brings these cells into close proximity and triggers T‑cell activation, immune synapse formation and targeted killing of the abnormal plasma cells. This rapid depletion of plasma cells reduces the production of pathogenic light chains that form amyloid deposits, which is central to controlling systemic AL amyloidosis.
What is the efficacy of linvoseltamab in systemic AL amyloidosis (preliminary LINKER‑AL2 data)?
In the preliminary Phase 1/2 analysis of LINKER‑AL2, 20 adults with second‑line‑plus systemic AL amyloidosis received subcutaneous linvoseltamab at either 80 mg (n=7) or 240 mg (n=13), and 60% had previously received daratumumab‑containing regimens.
With a median follow‑up of 9.5 months (range 1.6–13.3 months), no dose‑limiting toxicities were observed at either dose.
All patients achieved a hematologic response.
At 80 mg, 100% (7/7) reached at least a very good partial response and 71% (5/7) achieved complete response.
At 240 mg, 100% (13/13) achieved complete response.
Among the 17 patients remaining on study at data cut‑off, no hematologic progression was reported, suggesting durable disease control within current follow‑up.
How fast does linvoseltamab work in AL amyloidosis?
Treatment with linvoseltamab led to rapid and deep reductions in involved free light chains, which normalized by day 15 across dose levels, indicating swift clearance of the pathogenic plasma cells. The median time to hematologic complete response was 47 days (range 7–240 days), showing that many patients can reach deep remissions within weeks.
What organ benefits have been observed so far?
In this early analysis, linvoseltamab was associated with meaningful organ signals in systemic AL amyloidosis. Among patients with kidney involvement, 73% (8 of 11) showed renal improvement, and among those with cardiac involvement, 50% (4 of 8) demonstrated biochemical improvement in cardiac function. No patients experienced major organ deterioration during the reported follow‑up period.
What is known about safety in this setting?
Across both dose levels in LINKER‑AL2, all patients experienced at least one treatment‑emergent adverse event, which is expected in a heavily pretreated, high‑risk population. However, no dose‑limiting toxicities were seen in the preliminary dataset, and safety monitoring is ongoing as the Phase 2, registrational‑intent portion of the trial continues.
NOVARTIS
Pluvicto Shows Consistent Benefit Across Key Subgroups in Metastatic Hormone-Sensitive Prostate Cancer
Pluvicto plus standard treatment improved radiographic progression-free survival in PSMAddition, with benefits seen across disease volume and metastatic presentation.
Secondary outcomes, including PSA progression and time to metastatic castration-resistant prostate cancer, also supported the treatment effect, while the safety profile remained in line with expectations.
In the overall population, the hazard ratio for radiographic progression-free survival was 0.72. Among patients with high-volume disease (779 patients), the hazard ratio was 0.72, and in those with low-volume disease (365 patients), it was 0.73.
AcTION Phase 1 Data
Beyond Pluvicto, Novartis is aggressively investigating its next-generation asset, 225Ac-PSMA-617. Phase 1 findings from the AcTION trial offer an early look at the company’s transition toward actinium-based therapies.
Early signals from the study indicate:
Antitumor Activity: Notable reductions in PSA levels and positive radiographic responses.
Safety Profile: Early reports suggest the therapy is manageable, providing a solid foundation for further clinical development.
Scemblix delivers superior deep molecular response and durable safety at 144 weeks in newly diagnosed CML
Scemblix (asciminib) continues to look stronger than standard TKIs in the frontline CML setting, with nearly three years of follow‑up now backing its depth and durability of response alongside a steady safety profile.
Scemblix at nearly three years: how deep are the responses?
New 144‑week results from the Phase III ASC4FIRST study show that asciminib keeps widening the efficacy gap versus investigator‑chosen TKIs in newly diagnosed chronic‑phase CML. A greater share of patients were still on asciminib at the data cut‑off compared with the overall standard‑of‑care TKI arm, as well as versus imatinib specifically and versus second‑generation TKIs, which points to sustained benefit and tolerability over the long term.
By week 144, major molecular response had become the norm rather than the exception for patients on asciminib. In the all‑comers population, 77.1% of patients on asciminib reached MMR, compared with 53.4% on investigator‑selected TKIs. When looking by pre‑specified strata, asciminib delivered MMR in 79.2% of patients in the imatinib‑eligible group versus 47.1% on imatinib, and in 75.0% of those in the second‑generation TKI group versus 59.8% on 2G TKIs.
Depth of response followed the same pattern. At week 144, 55.7% of patients on asciminib achieved MR4, versus 36.3% on standard TKIs overall. In the imatinib stratum, MR4 rates were 58.4% on asciminib versus 33.3% on imatinib, while in the second‑generation TKI stratum, 53.0% versus 39.2% reached MR4 with asciminib and 2G TKIs, respectively.
These deeper molecular responses are clinically meaningful because they are associated with more durable disease control and may open the door to treatment‑free remission discussions for more patients in the future.
On the safety side, the 144‑week readout did not reveal any new concerns.
ROCHE
Roche highlights giredestrant’s evolving role in breast cancer treatment
Roche continues to build on its recent data, reinforcing giredestrant’s potential to reshape the treatment paradigm in early breast cancer and expand its role across advanced disease.
What is the mechanism of action of giredestrant?
Giredestrant is an investigational, oral, selective oestrogen receptor degrader (SERD) being developed for ER‑positive, HER2‑negative breast cancer across both early and advanced settings. This subtype accounts for about 70% of all breast cancers, and most patients are diagnosed at an early stage.
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Results from three Phase III trials will underpin future discussions on how giredestrant may become a key endocrine therapy option across multiple stages of disease:
lidERA Breast Cancer
Following the previously reported reduction in the risk of invasive disease recurrence or death, new lidERA data will continue to inform how giredestrant performs in both premenopausal and postmenopausal patients with early breast cancer. These findings will support ongoing regulatory and clinical discussions with the US FDA.
persevERA Breast Cancer
The persevERA primary results will remain important for understanding giredestrant in combination with palbociclib as a first‑line option for locally advanced or metastatic endocrine‑sensitive disease. Although the primary endpoint is not met, the numerical improvement in progression‑free survival suggests that giredestrant retains activity in the first‑line setting and may guide future study designs.
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evERA Breast Cancer
Updated post‑progression analyses from evERA will continue to highlight the sustained clinical benefit of giredestrant plus everolimus after prior CDK4/6 inhibitor therapy. These data support the recently accepted New Drug Application with the US FDA and will shape how the regimen is positioned in later‑line treatment strategies.
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