On April 19, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported updated Phase 1 (RMC-9805-001) clinical data for zoldonrasib, an oral RAS(ON) G12D-selective inhibitor, in patients with previously treated KRAS G12D non-small cell lung cancer (NSCLC). Results were highlighted in the official press program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and will be featured in a plenary oral presentation today, April 19, 2026, at 1:30 p.m. PDT.

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"Patients with RAS G12D non-small cell lung cancer remain a population with a significant unmet medical need for targeted therapeutic options," said Jonathan Riess M.D., medical director of thoracic oncology at UC Davis Comprehensive Cancer Center and principal investigator for the RMC-9805-001 trial. "The manageable safety profile and evidence of clinical activity in this Phase 1 trial are encouraging and support the continued clinical development of zoldonrasib."

"We believe these updated data further strengthen the profile of zoldonrasib as a potentially important targeted therapy for patients with RAS G12D non-small cell lung cancer where historical treatment options, such as chemotherapy, have offered limited benefit, and are often associated with considerable toxicity," said Alan Sandler, M.D., chief development officer of Revolution Medicines. "The emerging profile supports advancing zoldonrasib across monotherapy and combination settings in lung cancer and other RAS G12D-driven cancers."

Summary of Phase 1 Zoldonrasib Data at AACR (Free AACR Whitepaper) 2026 (Abstract # CT021)

RMC-9805-001 is a multicenter, open-label, dose escalation and dose expansion Phase 1 trial designed to evaluate zoldonrasib in patients with advanced solid tumors harboring a KRAS G12D mutation. The data to be presented at the AACR (Free AACR Whitepaper) Annual Meeting are as of a December 1, 2025 data cutoff, and included 40 patients with KRAS G12D NSCLC treated with zoldonrasib 1200 mg once daily, the recommended Phase 2 dose, and who were evaluable for safety. Efficacy analyses were conducted in a subset of patients with prior immune checkpoint inhibitor and platinum chemotherapy and no prior docetaxel treatment who had sufficient follow-up for response assessment (n=27).

Zoldonrasib was generally well tolerated and demonstrated a safety profile consistent with previously reported findings. Treatment-related adverse events (TRAEs) of any grade occurring in at least 15% of patients were nausea (43%), vomiting (33%), diarrhea (30%), and rash (18%). The majority of TRAEs were Grade 1 in severity. Grade 3 TRAEs occurred in 13% of patients and resolved following dose interruption; TRAEs led to treatment discontinuation in 5% of patients. No Grade 4 or Grade 5 TRAEs were observed. Zoldonrasib demonstrated a favorable mean dose intensity of 94%.

Zoldonrasib demonstrated encouraging clinical activity in patients with KRAS G12D NSCLC previously treated with immune checkpoint inhibitor and platinum chemotherapy and no prior docetaxel. Among this subset of patients (n=27), the confirmed objective response rate was 52% (confidence interval (CI): 32, 71) and the disease control rate was 93% (CI: 76, 99). Median time to response was 1.4 months and median duration of response was not yet estimable (95% CI: 8.3, not estimable). Median progression-free survival (PFS) was 11.1 months (95% CI: 5.3, not estimable), with an estimated 12-month PFS rate of 48% (95% CI: 27, 66). Overall survival (OS) data were immature at the time of analysis, and median OS was not yet reached with median potential follow-up of 13.1 months (range: 9.1–19.9). Estimated survival rate at 12 months was 73% (95% CI: 52, 86), suggesting encouraging early survival outcomes.

About Non-Small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) accounts for 80%-85% of all lung cancers, with more than 229,000 people diagnosed in the U.S. each year.1,2 Despite treatment advancements, NSCLC remains a leading cause of cancer-related mortality worldwide, primarily due to its late-stage diagnosis and limited response to conventional therapies. KRAS G12D is the most common oncogenic driver of human cancers and represents 4% of NSCLC cases.3

About Zoldonrasib
Zoldonrasib is a tri-complex inhibitor that binds to cyclophilin A, creating a complex that selectively recognizes and inhibits the active, oncogenic RAS G12D(ON) mutant. KRAS G12D is the most prevalent RAS mutation, accounting for 29% of all RAS cancers, and currently lacks an approved targeted therapy.4 Across tumor types, approximately 61,000 new patients with RAS G12D cancers are estimated each year in the United States.5 Zoldonrasib is currently being evaluated as a monotherapy and in combination with other therapies, including with Revolution Medicines’ RAS(ON) multi-selective inhibitor daraxonrasib (RMC-6236), as well as standard of care regimens in lung and gastrointestinal cancers.

(Press release, Revolution Medicines, APR 19, 2026, View Source [SID1234664519])

On April 18, 2026 Pliant Therapeutics, Inc. (Nasdaq: PLRX) reported the presentation of updated data from its Phase 1 trial of PLN-101095, in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. The oral presentation was made at the Clinical Trials Mini Symposium of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 Annual Meeting.

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Timothy A. Yap, MBBS, Ph.D., Medical Oncologist and Physician-Scientist at the University of Texas MD Anderson Cancer Center, presented results from the dose escalation portion of the ongoing Phase 1a/1b trial covering data as of February 27, 2026. Results showed that in the heavily pretreated ICI-secondary refractory patient subgroup, twice daily (BID) treatment with PLN-101095 at the highest doses in combination with the ICI pembrolizumab showed antitumor activity. One confirmed overall complete response, two confirmed overall partial responses, including one patient with a complete response of baseline target lesions, and one unconfirmed partial response were reported in patients with cholangiocarcinoma, non-small cell lung cancer (NSCLC), melanoma and head and neck squamous cell carcinoma, respectively. As of the data cutoff date, the median time on treatment for the three confirmed responders was 19 months, who experienced an average baseline target tumor reduction of 89%.

All responding patients showed large increases (4- to 13-fold vs. baseline) in plasma interferon gamma (IFN-γ) after a 14-day run-in period of monotherapy with PLN-101095. At Week 10, all responders maintained more than a 2-fold increase in IFN-γ. No non-responders showed meaningful increases in IFN- γ. In addition to IFN- γ increases, all responding patients showed elevated plasma PD-L1 levels, known to be induced by increased IFN-γ and a predictor of an improved ICI response. As increases in IFN-γ have the potential to serve as a biomarker of TGF-β inhibition and an early indicator of PLN-101095 anti-tumor activity. Pliant anticipates further study of this biomarker as part of the expansion cohorts in the Phase 1b trial.

PLN-101095 was generally well tolerated across all doses evaluated with few discontinuations (n=2) due to adverse events. Rash was the most common treatment-related adverse event (TRAE), all Grade 1 or 2, and the majority of events occurred within the first 2 days of the initial pembrolizumab dose. One Grade 3 TRAE was observed.

PLN-101095 demonstrated a dose-ordered exposure at Day 14 with doses ≥1000 mg BID achieving sustained IC90 coverage and all participants dosed at ≥1000 mg BID maintaining IC75 coverage over 24 hours. These results support the consistent target engagement of PLN-101095.

Sixteen patients with ten different tumor types, including both primary and secondary refractory patients, were enrolled in five dose cohorts. Patients were treated for 14 days with PLN-101095 monotherapy administered orally at doses of 250 mg twice a day (BID) (n=1), 500 mg BID (n=2), 1000 mg BID (n=6), 1000 mg three times a day (TID) (n=4) or 2000 mg BID (n=3), followed by the addition of pembrolizumab at 200 mg administered intravenously every three weeks until disease progression. Scans were conducted at baseline, Day 14, Week 10, and every 8 weeks thereafter.

Dr. Yap commented "One of the ways that the tumor microenvironment can suppress responses to immune checkpoint inhibitors is through a process that is activated by integrins to upregulate TGF-β. PLN-101095 is designed to inhibit the integrins before they can ever do that, which gives it significant potential to stimulate or reinvigorate the immune response to cancer. These clinical trial data, for the combination of PLN-101095 and pembrolizumab in patients with secondary immune checkpoint inhibitor resistance, show the potential to meet a high unmet therapeutic need."

"These encouraging results show a deepening of baseline tumor reductions in confirmed responders and an increased median time on treatment with PLN-101095 in patients with difficult-to-treat ICI refractory tumors," said Bernard Coulie, M.D., PhD., Chief Executive Officer of Pliant. "We have initiated the Phase 1b trial to expand this novel combination therapy in specific tumor types to address patients in need and deliver value to our investors."

Slides accompanying these data can be found here and under the Investors & Media page of Pliant’s website at www.PliantRx.com.

PLN-101095 Phase 1b Indication Expansion Trial

Pliant has initiated a Phase 1b open-label indication expansion trial enrolling three cohorts of patients with NSCLC, tumors with high tumor mutational burden or clear cell renal cell carcinoma. Patients will be treated for 14 days with PLN-101095 dosed at 1,000 mg twice daily as monotherapy, after which pembrolizumab will be added as combination therapy. Enrollment is underway with interim data expected in 2027.

PLN-101095 for the Treatment of Checkpoint Resistant Tumors

PLN-101095 is an oral, small molecule inhibitor of integrins αvβ8 and αvβ1. PLN-101095 is being evaluated in Phase 1a/1b open-label, dose-escalation and indication expansion trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. Activated transforming growth factor-β (TGF-β) has been shown to foster an immuno-suppressive tumor microenvironment (TME) that contributes to immune-checkpoint inhibitor (ICI) resistance and treatment failure in cancer.1 Blocking integrins αvβ8 and αvβ1 has been shown to prevent the activation of TGF-β and is expected to stimulate immune activation by increasing immune cell infiltration into the tumor microenvironment.2,3 PLN-101095 in combination with an anti-PD-1 monoclonal antibody (mAb) elicited a dose-dependent reduction in tumor volume and increased CD8+ T cell tumor infiltration in the tumor microenvironment compared with anti-PD-1 mAb therapy alone.4 In preclinical studies, PLN-101095 demonstrated monotherapy activity in reduction of tumor volume and increased cluster of differentiation (CD)8+ T cell infiltration.

(Press release, Pliant Therapeutics, APR 18, 2026, View Source [SID1234664529])

On April 18, 2026 Moderna, Inc. (NASDAQ:MRNA) reported that the Company will present data from a Phase 1/2 study of mRNA-4359, an investigational cancer antigen therapy, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in San Diego, CA, on April 17-22, 2026. The presentation reports safety, efficacy and translational data from a Phase 2 dose-expansion cohort of the Phase 1/2 study (NCT05533697), which evaluated mRNA-4359 + pembrolizumab as a first-line therapy in patients with locally advanced or metastatic melanoma.

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Among 12 participants, mRNA-4359 + pembrolizumab resulted in an overall response rate (ORR) of 83% (95% CI: 52%-98%), with two patients achieving a complete response and eight achieving a partial response, as well as a disease control rate (DCR) of 92% (95% CI: 62%-100%). The median time to response was six weeks (range, 5.6-24.0). Responses occurred across baseline tumor PD-L1 expression categories, with an ORR of 88% (95%CI: 47%-100%) among patients with PD-L1+ (TPS≥1%) tumors, and 67% (95%CI: 9%-99%) among patients with PD-L1- (TPS<1%) tumors. Consistent with mRNA-4359’s mechanistic rationale, antigen-specific T-cell responses and novel expanded T-cell receptor (TCR) clonality was observed in all patients (n=7) with evaluable samples. mRNA-4359 + pembrolizumab demonstrated a manageable safety profile, with no new immune-related adverse events (AEs).

"This study evaluating mRNA-4359 + pembrolizumab as a first-line treatment option reflects our ambition to demonstrate the potential of mRNA technology throughout a cancer patient’s journey. While conducted among a small patient population, we are encouraged by the high response rates and mechanistic translational results," said David Berman, M.D., Ph.D., Chief Development Officer of Moderna. "We look forward to further evaluating the potential of mRNA-4359 in patients with melanoma."

"This early data supports the potential activity of the mRNA-4359 + pembrolizumab combination, with promising anti-tumor activity," Dr. Pavlina Spiliopoulou, School of Cancer Sciences, University of Glasgow, the abstract’s lead author and presenter. "The consistent activation of antigen-specific T-cell responses provides important early evidence that mRNA technology could be used to help direct the immune system against melanoma in a multi-targeted manner."

This presentation builds on promising early data presented at the 2025 European Society for Medical Oncology Congress, in which mRNA-4359 + pembrolizumab achieved an ORR of 24% and DCR of 60% among 29 evaluable patients with checkpoint inhibitor-resistant/refractory (CPI-R/R) melanoma. Among those with response-evaluable disease and PD-L1+ (TPS≥1%) tumors, the ORR was 67%.

The U.S. FDA has granted Fast Track designation for mRNA-4359 in combination with pembrolizumab for the treatment of CPI refractory unresectable or metastatic melanoma with PD-L1+ (TPS>1%). Fast Track is designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions and that fill an unmet medical need. Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application.

The details of the presentation are as follows:

Abstract Presentation #CT106: First-Line mRNA-4359 Plus Pembrolizumab (Pembro) in Locally Advanced or Metastatic Melanoma: Results from the Phase 1/2 mRNA-4359-P101 Study

Session Title: Clinical Trials Plenary 3: Cellular Therapies and Complex Immunotherapies

Session Date/Time: Monday, April 20, 10:15AM – 12:15PM PT

Presenter: Dr. Pavlina Spiliopoulou, School of Cancer Sciences, University of Glasgow, UK

About mRNA-4359

mRNA-4359 is an investigational, immune-evasion targeted cancer antigen therapy that encodes broad epitopes of PD-L1 and IDO1. With its dual mechanism of action, it is designed to elicit antigen-specific T-cell responses to simultaneously: (1) kill tumor cells expressing PD-L1 and IDO1, and (2) deplete immunosuppressive cells that shield the tumor from attack. This is hypothesized to rebalance the tumor microenvironment into an immune-permissive state, supporting sustained and durable anti-tumor activity with a manageable safety profile.

(Press release, Moderna Therapeutics, APR 18, 2026, https://feeds.issuerdirect.com/news-release.html?newsid=8054079664924385&symbol=MRNA [SID1234664479])

On April 17, 2026 Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, reported expansion cohort data from the Phase 1/2 study of JK06, a 5T4-targeted antibody drug conjugate (ADC), in patients with unresectable locally advanced or metastatic cancer, including non-small cell lung cancer (NSCLC) and breast cancer, which is being presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 on April 17-22, 2026 in San Diego, California.

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"JK06 continues to demonstrate encouraging and durable efficacy among heavily pre-treated metastatic solid tumors. Partial responses have now been observed across four different cancers, including NSCLC and breast cancer, at multiple dose levels. These data are complemented by a consistently favorable safety profile, underscoring our belief that JK06 has the potential to be an important new first-in-class ADC that can address the unmet needs of patients with 5T4-expressing cancers," said Sam Murphy, Chief Executive Officer of Salubris Biotherapeutics. "These results provide a robust foundation for further exploration of JK06 in NSCLC and breast cancer and will propel our efforts to interrogate the pan-tumor opportunity. We look forward to progressing this study into the next stages of expansion cohorts, including additional monotherapy cohorts and evaluation of JK06 in multiple combination therapy regimens."

Expansion cohort data presented at AACR (Free AACR Whitepaper) include 112 patients enrolled in Europe with advanced relapsed/refractory solid tumors who were treated with JK06 once every three weeks, including two randomized dose cohorts (3.7 mg/kg, 4.5 mg/kg) in NSCLC and breast cancer and a basket cohort consisting of multiple tumor types known to express 5T4. The data cutoff was March 29, 2026.

Key efficacy findings include:

Among 38 response-evaluable NSCLC patients, 10 attained confirmed PRs (ORR 26%), including three out of seven response-evaluable squamous cell NSCLC patients (ORR 43%), and two of three response-evaluable Epidermal Growth Factor Receptor (EGFR) mutant patients.
Five out of 19 response-evaluable breast cancer patients attained PRs (ORR 26%), including four out of nine hormone receptor-positive (HR+) breast cancer patients (ORR 44%).
Among other tumor types, the first and only response-evaluable gastric cancer patient enrolled attained a partial response (PR, -55%), and one of four response-evaluable cervical cancer patients attained a partial response (PR, -49%).
Among 112 safety-evaluable patients enrolled in expansion cohorts, key safety findings include:

Treatment with JK06 at doses ≤ 5.2 mg/kg was generally well-tolerated with predominantly low grade (Grades 1 and 2) treatment-related adverse events (TRAEs) and manageable toxicities.
All JK06-related AEs of any grade are below 10% frequency overall except for asthenia (11% overall).
Only three total Grade 3 events have been observed to date among the 112 patients (fatigue, gait disturbance, keratitis), and no Grade 4 or 5 events have been observed.
Of the total 153 patients enrolled across all dose levels in dose escalation and expansion, only seven patients have dose-reduced due to a TRAE resulting from JK06.

The Phase 1/2 open-label, dose-escalation and expansion study (NCT06667960) to assess the safety, pharmacokinetics, and preliminary efficacy of JK06 is ongoing.

Details of the AACR (Free AACR Whitepaper) presentation are as follows:

Title: A Phase 1/2 Study of JK06, a 5T4-Targeted Antibody Drug Conjugate (ADC), In Patients with Unresectable Locally Advanced or Metastatic Cancer
Presenter: Omar Saavedra, M.D., Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
Abstract #: CT250
Session: Phase II Clinical Trials
Date/Time: April 21, 2026 | 2:00 – 5:00 PM PT

About JK06

JK06 is a first-in-class quadrivalent, biparatopic ADC that selectively targets 5T4 with a monomethyl auristatin E (MMAE) payload. 5T4 is an oncofetal protein that is overexpressed in a wide range of solid tumors, including non-small cell lung cancer (NSCLC), breast, gastric and genitourinary cancers, and is associated with more aggressive tumor progression and reduced survival. JK06 has demonstrated picomolar affinity for 5T4 and enhanced internalization resulting from the biparatopic design. Together with stable, site-specific payload conjugation, JK06 has demonstrated the potential for robust efficacy and a favorable safety profile.

(Press release, Salubris Biotherapeutics, APR 17, 2026, View Source [SID1234664553])

On April 17, 2026 OREGA Biotech, the biotech company committed to the discovery of novel immuno-oncology targets for cancer immunotherapy, reported that the AACR (Free AACR Whitepaper) 2026 abstract reporting interim results from the phase 2 MATISSE trial of IPH5201 plus durvalumab (durvalumab) and platinum-based chemotherapy in patients with resectable early stage non-small cell lung cancer (NSCLC) has been published.

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Summary of the abstract: Perioperative PD-(L)1 inhibitors combined with chemotherapy are now standard for resectable early-stage NSCLC, but further improvements in pathological complete response (pCR) and survival are still needed. IPH5201, an anti-CD39 antibody, aims to enhance antitumor immunity by reducing immunosuppressive adenosine and increasing ATP levels. In the Phase 2 MATISSE study, IPH5201 was added to durvalumab and chemotherapy in patients with stage II–IIIA NSCLC. Among 40 patients, the treatment showed a favorable safety profile and achieved a pCR rate of 27.5% (all), rising to 35.7% in PD-L1 ≥1% and 50% in PD-L1 ≥50% patients, comparing favorably with the 17.2%, 21.2% and 27.5% reported for durvalumab + chemo in the AEGEAN study (Heymach, 2023). Biomarker analyses confirmed CD39 target engagement and suggested a link between CD39+ tumor cell density and response. These results compare favorably to prior standards and support the continuation of the study with the recruitment of PD-L1≥1% pts.

Presentation details:

Session CTPL04 – Advances in Immunotherapy
CT231 – Dual CD39 and PD-L1 inhibition: Interim results from the phase 2 MATISSE trial of IPH5201 plus durvalumab (durva) and platinum-based chemotherapy (CT) in patients (pts) with resectable NSCLC.

Session Date/Time: April 21, 2026, 10:45 AM – 11:00 AM Hall H – Ground Level – Convention Center

Presenter: Pr. Fabrice Barlesi, CEO of Institut Gustave Roussy

About IPH5201 antibody
IPH5201 is a humanized CD39 blocking antibody codeveloped by Innate Pharma and AstraZeneca (AZ).
OREGA Biotech entered into an exclusive and worldwide License Agreement with Innate Pharma in 2016. The lead antibody (IPH5201) has been further partnered with AstraZeneca in 2018. AstraZeneca conducted a multicenter, open-label, dose-escalation Phase 1 trial in advanced solid tumors (NCT04261075) with IPH5201 alone or in combination with durvalumab (anti PD-L1 antibody).

About NCT05742607 clinical trial
MATISSE is a Phase 2 multicenter single-arm study (NCT05742607) evaluating neoadjuvant and adjuvant treatment with IPH5201 in combination with durvalumab (anti-PD-L1, AZ) and chemotherapy in treatment-naïve patients with resectable early-stage non-small cell lung cancer (NSCLC). The primary objectives of the study are to assess antitumor activity of neoadjuvant treatment based on pathological complete response (pCR) and safety. More information on the Phase 2 clinical trial is accessible online.

(Press release, OREGA BIOTECH, APR 17, 2026, View Source [SID1234664546])