On May 31, 2026 Servier reported updated efficacy and safety results from more than three years of follow-up in the Phase 3 INDIGO trial evaluating VORANIGO (vorasidenib) versus placebo in patients with Grade 2 mutant isocitrate dehydrogenase 1 or 2 (IDH1/2) glioma following surgical intervention and who are not in immediate need of chemoradiotherapy. These data, which will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on May 31 at 4:36 p.m. CDT in Chicago, strengthen the previous findings from the INDIGO pivotal trial and demonstrate the clinical benefits of VORANIGO continue to improve over time.

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The extended analysis includes 21.3 months of additional unblinded data collected between the March 7, 2023, trial unblinding and the January 17, 2025, data cutoff. As of data cutoff, all 163 patients enrolled in the placebo arm discontinued treatment and 144 crossed over to the VORANIGO treatment arm. Median follow-up was 41.6 months. These results build upon the placebo-controlled, double-blind data previously published in The Lancet Oncology.

"The extended Phase 3 INDIGO trial analysis significantly improves our understanding of the clinical benefits of VORANIGO," said Islam Hassan, M.D., MSc., Global Head of Development-Neuro-Oncology at Servier. "With more than three years of follow-up data, these results validate the durable and sustained benefits of long-term treatment with VORANIGO and demonstrate a steady improvement in patient responses over time. We are proud to share these results and remain committed to expanding our understanding of the long-term impact of VORANIGO for the glioma community."

A global, randomized, double-blinded, Phase 3 trial of vorasidenib vs placebo in patients with grade 2 glioma with an IDH1/2 mutation (INDIGO): updated efficacy and safety – Sunday, May 31, 4:36 – 4:42 p.m. CDT

Key findings, which were presented by Timothy Cloughesy, M.D., David Geffen School of Medicine, Department of Neurology, University of California, Los Angeles, an investigator for the INDIGO trial, include:

Median progression-free survival (PFS) per blinded independent review committee (BIRC) was 44.1 months (95% CI, 27.7-not estimable [NE]) in patients treated with VORANIGO. PFS was the primary endpoint of the trial.
The median time to next intervention (TTNI) per BIRC for patients treated with VORANIGO was NE (95% CI, 52-NE). The number of next-intervention events remained low among VORANIGO patients (23.8%), indicating that VORANIGO is effectively delaying the need for subsequent treatment. TTNI was a key secondary endpoint of the trial.
Patients treated with VORANIGO experienced an objective response rate (ORR) per BIRC of 20.8% (95% CI, 15%-27.8%). ORR improved with longer follow-up, reflecting durable and gradual responses with VORANIGO. An additional 72.6% of patients experienced stable disease.
Median duration of treatment among VORANIGO patients was 38.3 months (95% CI, 19.98-43.76).
A 72% reduction in the rate of on-treatment seizures was observed in patients treated with VORANIGO.
The safety profile of VORANIGO was tolerable with mainly low-grade adverse events (AEs) and consistent with previously reported data. The most commonly reported Grade ≥3 or worse treatment-emergent adverse events (TEAEs) were increased alanine aminotransferase (10.8%), increased aspartate aminotransferase (4.8%), seizures (4.8%), increased gamma-glutamyltransferase (3%) and syncope (1.8%). No new safety signals were detected and fewer than 5% of patients discontinued treatment due to an AE. There were no treatment-related deaths.
"Historically, many patients with Grade 2 IDH-mutant gliomas faced a poor long-term prognosis and managed their disease with a ‘watch and wait’ strategy due to the limited availability of targeted treatment options," said Dr. Timothy Cloughesy. "The latest results from the Phase 3 INDIGO trial—the largest dataset in IDH-mutant glioma to date—provide valuable evidence on how long-term IDH inhibition can delay disease progression and extend the time to next intervention."

Impact of vorasidenib vs placebo on seizure rates and quality of life: exploratory analysis from Phase 3 INDIGO study – Monday, June 1, 1:30 – 4:30 p.m. CDT

Findings from an exploratory analysis of the INDIGO study evaluating the impact of VORANIGO on seizure rates and quality of life will be shared in a separate presentation. As of data cut off in January 2025, results show:

The rate of seizures per person per year in the VORANIGO arm (15.9 seizures per person-year [95% CI, 9.1-27.7]; p=0.0002) demonstrated the sustained, positive, long-term effect of VORANIGO on seizure control.
The effects of VORANIGO were more pronounced among people with oligodendrogliomas (6.9 seizures per person-year [95% CI, 2.7-17.7]; p<0.0001) than those with astrocytoma (17.5 seizures per person-year [95% CI, 9.4-32.3]; p=0.6448).
VORANIGO had an acceptable safety profile with no new safety signals during extended follow-up.

(Press release, Servier, MAY 31, 2026, View Source [SID1234666268])

On May 31, 2026 TiumBio Co., Ltd. (KOSDAQ: 321550), a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapeutics, reported clinical data for Tosposertib (TU2218), an oral dual inhibitor targeting transforming growth factor-beta (TGF-β) and vascular endothelial growth factor (VEGF), in first-line (1L) recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026.

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The data presented during the poster session included the latest results and follow-up data from the Phase 2a trial evaluating the combination of Tosposertib and Keytruda (Pembrolizumab) as. In addition to the 75% response rate in the first-line (1L) patient group (including 1 CR and 8 PR), which drew attention upon abstract release on May 22, the presentation also disclosed progression-free survival (mPFS) and overall survival (mOS) data for the first time.

According to the research poster presented by Tiumbio at ASCO (Free ASCO Whitepaper) 2026, as of the data cutoff date of March 31, 2026, the median progression-free survival (mPFS*) in a total of 12 first-line (1L) patients was 10.9 months. While cross-trial comparisons are inherently limited, this result compares favorably with historically reported PFS outcomes for standard-of-care pembrolizumab monotherapy and pembrolizumab plus chemotherapy. In addition, an 83% response rate was observed in the high CPS (>20) subgroup (n=6), while a 67% response rate was also observed in the low CPS 1–19 subgroup (n=6), a patient population that may derive relatively limited benefit from immuno-oncology therapies.

The median overall survival (mOS*) had not yet been reached (NR), with a substantial proportion of patients remaining alive and continuing on treatment or follow-up at the time of analysis.

(*) mPFS (Median Progression-Free Survival): the median length of time during which 50% of patients enrolled in the clinical trial experienced neither disease progression nor death.
(*) mOS (Median Overall Survival): the median length of time from initiation of treatment in the clinical trial until death from any cause, regardless of disease progression.

The dataset included 14 patients receiving 2nd-line or later treatment after relapse following prior standard therapy. In this subgroup, the combination achieved a response rate of 42.9% (including 1CR and 5 PR). The mPFS was 2.9 months, while mOS had not yet been reached (NR). By comparison, currently available standard treatment options in 2nd-line or later settings for R/M HNSCC typically show response rates of approximately 10% to 15%, with mPFS of 2.1 months. These findings suggest that Tosposertib and Keytruda combination may offer meaningful clinical advantage even in later-line patients who have limited treatment options after failure of existing therapies.

In addition, the combination was generally manageable, and safety findings were generally consistent with the known profiles of the agents and the underlying patient population. The incidence of Grade 3 or higher treatment-related adverse events (TRAEs) observed with the combination of Tosposertib and Keytruda was 48.3%. No Grade 5 treatment-related adverse events leading to patient death or cardiovascular toxicities were reported.

Professor Hye Ryun Kim of the Division of Medical Oncology at Yonsei University Severance Hospital, one of Korea’s leading experts in head and neck cancer treatment and the first author who personally presented the poster at ASCO (Free ASCO Whitepaper), commented, "The interim data presented at ASCO (Free ASCO Whitepaper) 2026 represents a differentiated clinical outcome that highlights the potential therapeutic benefit of Tosposertib in recurrent or metastatic head and neck cancer. In this disease setting, where treatment remains challenging and patient prognosis is often poor, we believe Tosposertib has significant potential to emerge as a new treatment option capable of addressing the limitations of existing therapies."

Hun-taek Kim, CEO of Tiumbio, stated, "We believe these interim data presented at ASCO (Free ASCO Whitepaper) 2026 demonstrated a compelling clinical profile compared with outcomes historically observed with current standard of care. Based on these data, we plan to evaluate potential regulatory pathways, including the possibility of seeking Breakthrough Therapy Designation, as we continue to advance Tosposertib toward its potential to become a new standard of care in R/M HNSCC."

About Tosposertib (TU2218)
Tosposertib (TU2218) is a highly potent, oral dual inhibitor designed to block the signaling pathways of transforming growth factor-beta (TGF-β) and vascular endothelial growth factor (VEGF), two critical mediators of tumor growth and metastasis. This novel drug candidate was discovered and developed by Tiumbio to enhance the therapeutic efficacy of immune-oncology agents such as Keytruda.

(Press release, TiumBio, MAY 31, 2026, View Source [SID1234666267])

On May 31, 2026 ImmVira Group ("ImmVira") reported that preliminary Phase IIa clinical data for MVR-T3011, its lead oncolytic immunotherapy candidate, was presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. As of the data cut-off on January 31, 2026, the optimized dose of MVR-T3011 achieved a 100% complete response rate (CRR) in BCG-unresponsive carcinoma in situ (CIS) and a durable 90% recurrence-free survival (RFS) in papillary (Ta/T1) tumors[1].

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While intravesical instillation of Bacillus Calmette-Guérin (BCG) remains the standard of care for high-risk NMIBC-representing 75% of all newly diagnosed bladder cancer cases, a global BCG shortage and high rates of non-response leave a significant patient population without effective options. MVR-T3011 was developed with the goal of delivering potent local and systemic anti-tumor immunity directly within the bladder, offering a potential organ-preserving treatment option for this high-need population.

The ongoing trial enrolled 46 patients in total with pathologically confirmed BCG-unresponsive high-risk NMIBC. Patients received intravesical MVR-T3011 at one of two dose levels:

Lower-dose group (2×109 PFU): Induction course followed by maintenance dosing over two years (n=25).
Higher-dose group (1×1010 PFU): Induction course followed by maintenance dosing over two years (n=21).
The results demonstrate that MVR-T3011 achieved meaningful clinical efficacy and a favorable safety profile across both carcinoma in situ (CIS) and papillary (Ta/T1) disease settings：

In the CIS cohort, the higher-dose 1×1010 PFU regimen achieved a 100% complete response rate (CRR) at 3 months, 6 months, and 9 months, as well as at any assessed timepoint— a marked step up from the lower-dose 2×109 PFU cohort, which achieved a 66.7% CR rate at any timepoint (with timepoint-specific CRRs of 55.6% at 3 months and 75.0% at 6 months). The 12-month CRR for the 1×1010 PFU cohort has not yet been reached, with follow-up ongoing.
In the papillary (Ta/T1) cohort, the 2×109 PFU dose delivered a durable 12-month recurrence-free survival (RFS) of 74.0%, an already strong outcome; at the higher 1×1010 PFU dose, 9-month RFS reached 90.0%, with longer-duration follow-up ongoing.
Across all 46 patients treated, MVR-T3011 demonstrated a manageable safety profile consistent with prior observations. Importantly, the higher-dose 1×1010 PFU cohort showed a safety profile consistent with the lower-dose 2×109 PFU cohort, with no Grade 4 or 5 TEAEs reported across either dose level, or no deaths attributable to treatment.

"The presentation of these Phase IIa results at ASCO (Free ASCO Whitepaper) 2026 marks a meaningful milestone for ImmVira and for the broader NMIBC community," said Dr. Grace Zhou, Chairwoman and CEO of ImmVira. "MVR-T3011 has demonstrated great therapeutic potential through both direct anti-tumor activity in CIS and immune suppression in papillary (Ta/T1) disease. This represents a synergy of direct oncolysis and immune activation, further enhanced by the integrated effects of exogenous IL-12 and PD-1 antibody expressions within tumor cells. We are committed to rapidly advancing our clinical program to reach broader bladder cancer patient populations and provide meaningful treatment alternatives for those in need.

[1] Due to the small sample size and the early, interim nature of the data, the observed CRR and RFS are subject to statistical uncertainty and are inherently susceptible to change as patient enrollment continues and follow-up matures. These preliminary results should not be construed as an indication of the final outcomes of the current study, nor should they be regarded as predictive of results that may be achieved in a future confirmatory phase III clinical trial or in connection with any regulatory review or approval.

About MVR-T3011

MVR-T3011, represents a breakthrough in HSV-1-based oncolytic immunotherapy. Its proprietary "3-in-1" design unites a replication-competent, tumor-lytic HSV-1 backbone with anti-PD-(L)1 antibody and IL-12, enabling it simultaneously to lyse tumor cells and stimulate innate and adaptive immunity. MVR-T3011 has demonstrated its adaptability and feasibility across multiple routes of administration including intratumoral, intracavitary and intravenous administrations.

(Press release, Immvira, MAY 31, 2026, View Source [SID1234666266])

On May 31, 2026 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported updated data from the Phase 1 PoC clinical study of its first-in-class PD-1/IL-2α-bias bispecific fusion protein IBI363 (Takeda R&D code: TAK-928) in the treatment of advanced immunotherapy(IO)-resistant non-small cell lung cancer (NSCLC) The detailed data was presented today at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The updated data is from a PoC clinical study conducted in China to evaluate the safety and efficacy of IBI363 monotherapy in subjects with advanced NSCLC (ClinicalTrials.gov, NCT05460767). As of the follow-up cutoff date of November 20, 2025, a total of 136 subjects with NSCLC had received IBI363 monotherapy (2 μg/kg QW~4mg/kg once every 3 weeks, Q3W).

IBI363 Showed Robust Survival Benefits with a Long Tail Effect in IO-Resistant Squamous NSCLC

All 67 squamous NSCLC patients had no known EGFR mutations. Among them, 28 patients received IBI363 at 1 mg/kg Q2W or 1.5 mg/kg Q3W, and 31 patients received IBI363 at 3 mg/kg Q3W. In the 3 mg/kg Q3W dose group, the median PFS reached 10.1 (95%CI 6.0, 14.0) months, and the median OS achieved 18.2 (95%CI 10.7, NE; maturity 48.4%) months, with a 24-month OS rate of 47.8% (95%CI 28.7, 64.7).
IBI363 Showed Potential for Long-Term Survival Benefits with a Long Tail Effect in IO-Resistant Wild-type AdenoNSCLC, Especially in Patients with a Smoking History

Among the 58 patients with EGFR wild-type adenoNSCLC, 30 patients received IBI363 at 0.6 mg/kg Q2W or 1 mg/kg Q2W or 1.5 mg/kg Q3W, and 25 patients received IBI363 at 3 mg/kg Q3W. In the 3 mg/kg dose group, the median PFS reached 4.2 (95%CI 3.0, 7.0) months, and the median OS achieved 15.2 months (95%CI 9.6, NE; maturity 56.0%), with a 24-month OS rate of 42.7% (95%CI 23.1, 61.0).
Smoking history may be an important influencing factor for efficacy in immuno-resistant adenoNSCLC. In adenoNSCLC subjects with a smoking history, better survival benefits were observed. The median OS for smokers across all dose groups (N=31) reached 23.4 (95%CI 11.3, NE, maturity 48.4%) months.
IBI363 Showed a Favorable Safety Profile in Long-Term Follow-up

In the long-term follow-up of the overall population (n = 136), IBI363 demonstrated a favorable safety profile: treatment-emergent adverse events (TEAEs) of grade 3 or above occurred in 30.6% of patients treated with 1/1.5 mg/kg and 64.9% of patients treated with 3mg/kg.
The most common adverse events among all patients were arthralgia (52.2%, 3.7% ≥grade 3), anemia (46.3%, 4.4% ≥grade 3), and rash (39.0%, 8.8% ≥grade 3), which were mostly controllable and manageable with mild-to-moderate AEs. No new safety signals were observed.
Professor Jianya Zhou, The First Affiliated Hospital, School of Medicine, Zhejiang University, commented: "Lung cancer remains the most commonly diagnosed and deadliest malignancy worldwide, representing a major public health challenge. Despite the transformative impact of immunotherapy on the treatment landscape of NSCLC, patients with wild-type NSCLC who experience disease progression following immunotherapy continue to face limited treatment options, with docetaxel-based standard-of-care therapy offering only modest efficacy.

In recent years, emerging approaches such as immunotherapy-based combinations and ADCs have brought new hope. However, multiple large-scale Phase III clinical trials in NSCLC patients who had failed both platinum-based chemotherapy and immunotherapy have not yet delivered satisfactory outcomes. Therefore, there remains a substantial and urgent unmet medical need in the post-immunotherapy setting for NSCLC.

As a PD-1/IL-2α-bias bispecific molecule, IBI363 has demonstrated encouraging clinical benefit in immunotherapy-resistant NSCLC, with both objective response rate (ORR) and progression-free survival (PFS) showing meaningful improvement. Notably, in the 3 mg/kg Q3W cohort, more than 40% of patients with either squamous or adenocarcinoma histology survived beyond 24 months. These findings highlight the potential of IBI363 to generate a durable immunotherapy tail effect and deliver long-term survival benefits for patients."

Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent, stated: "While immunotherapy has significantly improved survival outcomes for certain patients, treatment options remain extremely limited for patients with NSCLC who do not respond to immunotherapy and lack actionable driver gene mutations, making long-term survival difficult to achieve.The proof-of-concept (PoC) data presented at this year’s ASCO (Free ASCO Whitepaper) meeting are highly encouraging. IBI363 has demonstrated not only meaningful short-term disease control, but also, through extended follow-up, validated the unique long-term survival benefits of its dual mechanism of action, combining immune checkpoint blockade with cytokine agonism. We are excited about the potential of IBI363 to provide a novel treatment option for a broad population of patients and ultimately help deliver durable, long-term survival benefits."

About IBI363 (PD-1/IL-2α-bias Bispecific Fusion Protein)

IBI363 is a first-in-class PD-1/IL-2α-bias bispecific fusion protein developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2 to the tumor through binding to IL-2 receptor alpha.

IBI363 is being evaluated in a series of clinical trials globally, led by a pivotal Phase II study in China in previously untreated acral and mucosal melanoma and a global multi-regional Phase III trial in immunotherapy-resistant squamous NSCLC. In parallel, multiple Phase Ib/II trials are evaluating IBI363 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types. IBI363 has received two Fast Track Designations (FTD) from the U.S. FDA and three Breakthrough Therapy Designations (BTD) from China NMPA so far.

In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363 (Takeda R&D code: TAK-928) globally and co-commercialize IBI363 in the U.S., and Takeda will exclusively commercialize IBI363 worldwide other than the U.S. and greater China.

(Press release, Innovent Biologics, MAY 31, 2026, View Source;innovent-presents-long-term-follow-up-results-from-the-poc-study-of-ibi363-tak-928-pd-1il-2-bias-bispecific-fusion-protein-showing-robust-survival-benefits-in-advanced-immunotherapy-resistant-non-small-cell-lung-302786450.html [SID1234666265])

On May 31, 2026 D3 Bio Inc., a global clinical-stage biotechnology company dedicated to developing innovative oncology therapeutics, reported first-line (1L) clinical data of elisrasib monotherapy and elisrasib in combination with pembrolizumab from an ongoing Phase I/II study of elisrasib (D3S-001), its next-generation KRAS G12C inhibitor, in patients with KRAS G12C mutation–positive (G12Cmut) non–small cell lung cancer (NSCLC). The data were presented in a Clinical Science Symposium at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois.

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Findings from both cohorts, which demonstrate favorable safety and tolerability profiles along with highly promising antitumor activity in 1L G12Cmut NSCLC across all levels of PD-L1 expression, support continued evaluation of elisrasib in the first-line setting.

Elisrasib as First-Line Monotherapy for Patients with KRAS G12C Mutation–Positive NSCLC

Elisrasib monotherapy demonstrated highly promising preliminary antitumor activity. Forty-three patients with previously untreated G12Cmut NSCLC received elisrasib 600 mg once daily in 21-day cycles, with a median study follow-up of 8.5 months. In 41 efficacy-evaluable patients, the overall response rate (ORR) was 78.0% was observed across all levels of PD-L1 expression, with 76.2% ORR in patients with PD-L1 TPS <1% (N=21) and 80.0% in patients with PD-L1 TPS of ≥1% (N=20), respectively. The disease control rate (DCR) was 95.1%. The median progression-free survival (mPFS) was 12.4 months (95% CI: 6.8, NR), with a 12-month PFS rate of 50.8%. Median overall survival (OS) was not reached, with a 12-month OS rate of 90.0%. As of the data cutoff, 60.5% of patients remained on study treatment.

Elisrasib monotherapy was well tolerated, with Grade 3 or higher TRAEs observed in only 7% of patients and serious TRAEs in 2.3% of patients. No TRAEs led to elisrasib discontinuation, and no dose reductions were required.

Elisrasib plus Pembrolizumab as First-Line Combination Therapy for Patients with KRAS G12C Mutation–Positive NSCLC

Fifty-two patients with previously untreated G12Cmut NSCLC received elisrasib 600 mg once daily in combination with pembrolizumab 200 mg every 3 weeks (Q3W), with a median study follow-up of 5.7 months. Notably, the dose of elisrasib used in combination is elisrasib’s RP2D at 600mg QD which provides complete KRAS G12C target coverage.

The combination of elisrasib and pembrolizumab showed highly compelling antitumor activity in patients with previously untreated G12Cmut NSCLC. In 48 efficacy-evaluable patients, an ORR 81.3% was observed across all PD-L1 expression levels, with ORR of 70.6% in patients with PD-L1 TPS <1% (N=17), 72.7% in patients with PD-L1 TPS of 1% to 49% (N=11), and 95.0% in patients with PD-L1 TPS ≥50% (N=20), respectively. The overall DCR was 97.9%. The median PFS was not reached (95% CI: 8.4, NR), with a 6-month PFS rate of 74.6% and a 12-month PFS rate of 53.7%. Median OS was not reached, with a 12-month OS rate of 88.8%. As of the data cutoff, 82.7% of patients remained on study treatment.

The combination regimen demonstrated a safety profile consistent with the known profiles of each agent. Grade 3 or higher TRAEs occurred in 32.7% of patients, with most severe events attributable to pembrolizumab, and serious TRAEs reported in 17.3% of patients. No new or unexpected safety signals were identified for elisrasib, and the overall safety profile compared favorably with the established standard-of-care regimen of pembrolizumab plus chemotherapy.

Expert Commentary

Prof. Shun Lu, M.D., Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, and lead study presenter, said: "The first-line results for elisrasib are very encouraging, showing strong and consistent antitumor activity across PD-L1 expression subgroups, both monotherapy and in combination with pembrolizumab. Its favorable tolerability and rapid response onset further highlight its potential as a promising treatment option for patients with KRAS G12C-mutant NSCLC."

"The compelling activity of elisrasib as monotherapy and in combination with pembrolizumab observed in the first-line NSCLC represents an exceptionally promising signal in this historically difficult-to-treat population," said Dr. George Chen, Founder, Chairman, and Chief Executive Officer of D3 Bio. "We believe these results support the continued and accelerated evaluation of elisrasib in Phase 3 randomized studies."

About Elisrasib (D3S-001)

Elisrasib is a next-generation KRAS G12C inhibitor designed for rapid, complete, and selective target engagement. It covalently binds the GDP-bound (OFF) form of KRAS G12C, effectively blocking nucleotide cycling and suppressing oncogenic signaling. Preclinical studies show robust potency, complete KRAS G12C engagement at clinically relevant exposures, and CNS penetration capability. Elisrasib is currently being evaluated globally in a Phase 2 monotherapy and combination trial across KRAS G12C–mutant solid tumors including NSCLC, CRC, and others.

(Press release, D3 Bio, MAY 31, 2026, View Source [SID1234666264])