On June 2, 2026 Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on developing new products for rare diseases, and Vanderbilt Health reported data from a Phase 2a clinical trial of ifetroban to prevent metastasis in high-risk solid tumors. The study’s primary safety endpoint was achieved, along with favorable trends in decreased metastasis recurrence and metastasis-free survival. A safe and effective medication that reduces distant metastatic recurrence could transform cancer management and improve the lives of millions of cancer survivors and their families.

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The randomized, double-blind, placebo-controlled Phase 2a trial evaluated the safety of ifetroban, an investigational thromboxane A2 receptor antagonist, in patients with solid tumors at high risk of early metastatic recurrence. Cancer types included breast, lung, pancreatic, soft tissue, bladder, and renal cancers.

The study met its primary endpoint, demonstrating that ifetroban was safe and well-tolerated in this patient population. Rates for adverse events related to treatment were similar between placebo and ifetroban. No serious adverse events (> grade 3) in either group were identified as being related to study treatment. Treatment discontinuation rates were not statistically different between placebo and ifetroban.

Although primarily a safety study and intentionally not powered for efficacy, the study compared the percentage of patients with distant metastatic recurrence 12 months after completion of therapy in both groups (10 placebo-treated and 18 ifetroban-treated participants) as a prespecified secondary endpoint. While 50% of participants experienced distant metastatic recurrence in the placebo arm, only 17% of participants experienced distant metastatic recurrence in the ifetroban arm (p=0.091). Three deaths due to distant metastatic disease occurred in the placebo arm, and none occurred in the ifetroban arm (p=0.037).

Though metastasis is a primary driver of cancer lethality, most current therapies act on tumor cells directly. Approaches targeting the mechanisms underlying the metastatic process are lacking. Even during clinical remission, microscopic metastases can remain present, leaving many patients at serious risk for metastatic recurrence. The premise of this novel therapy is that antagonizing the thromboxane A2 receptor and blocking platelet activation and aggregation lessens tumor cells’ ability to migrate, spread, cluster, invade distal organs, and evade immune detection.

This was the first trial evaluating the effects of ifetroban in people with solid tumors with high risk for early recurrence, defined as ≥ 50% chance of recurrence within 5 years of diagnosis. The intervention was given after all cancer-related therapies and surgical procedures had been completed; participants received the intervention for 12 months and were then followed for an additional 12 months. Among 29 participants, 10 received placebo and 19 received ifetroban.

"A therapeutic intervention aimed at metastasis prevention for cancer patients with high risk of recurrence that is given during the period of "watchful waiting" could be groundbreaking if proven beneficial in larger scale investigations," said Dr. Ben Ho Park of the Vanderbilt-Ingram Cancer Center. "We look forward to pursuing those pivotal studies as we relentlessly look for treatments to benefit patients living with cancer."

This clinical trial translated robust in silico and preclinical data to humans, confirming safety of ifetroban in patients with solid tumors and preliminarily suggesting that ifetroban may target biologic mechanisms involved in distant metastatic recurrence. A phenome-wide association study (PheWAS) was conducted by Vanderbilt Health investigators using the BioVU biorepository, which linked a naturally occurring genetic variant in the thromboxane receptor gene (TBXA2R) to an increased risk of metastatic disease across multiple cancer types.

Preclinical studies subsequently published in Molecular Cancer Therapeutics demonstrated that ifetroban reduced metastasis in several animal models without affecting tumor growth, and that the drug’s effects appeared to involve strengthening of the vascular endothelial barrier and inhibiting the ability of tumor cells to migrate across blood vessel walls.

"The favorable safety profile of ifetroban in this patient population, combined with the efficacy signals observed in this study, supports continued investigation of ifetroban as a candidate for metastasis prevention," said A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals. "The contributions of the Vanderbilt Health team have been essential to advancing this program."

Results of this Phase 2a clinical trial will be used to guide the further clinical development verifying efficacy and further demonstrating safety.

About Ifetroban

Ifetroban is a potent and selective thromboxane-prostanoid receptor (TPr) antagonist. It exhibits high affinity for TPr on many cell types including platelets, cardiomyocytes, vascular and airway smooth muscle, and fibroblasts, and lacks agonistic activity. Cumberland is also evaluating ifetroban in Phase 2 clinical programs for patients with Duchenne Muscular Dystrophy, Systemic Sclerosis and Idiopathic Pulmonary Fibrosis. Ifetroban has a favorable safety profile as evidenced by multiple completed clinical trials collectively enrolling over 1,400 people.

(Press release, Cumberland Pharmaceuticals, JUN 2, 2026, View Source [SID1234666380])

On June 2, 2026 Creatv Bio, a Division of Creatv MicroTech, Inc. ("Creatv"), a liquid biopsy company focused on innovative diagnostics for cancer, and Neovia Oncology LLC, a Delaware based pharmaceutical company dedicated to developing novel oncology therapies, reported the signing of a strategic partnership agreement to collaborate on Neovia’s upcoming studies treating patients with advanced multiple drug resistant solid tumors who are entering late lines of therapy.

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The collaboration is expected to generate translational and biomarker data designed to improve patient stratification and deepen understanding of treatment response dynamics in advanced cancers.

In addition to its development as a systemic therapy, Neovia is also evaluating the broader platform potential of NEV-801 in next-generation oncology applications, including antibody-drug conjugate (ADC) strategies.

"We selected Creatv Bio because of their strong scientific capabilities and extensive experience supporting biomarker research across multiple solid tumor types," said Trevor Blake, Founder and CEO of Neovia Oncology. "By integrating advanced liquid biopsy technologies into our clinical development program, we hope to gain deeper insights into patient response patterns and resistance biology as we advance NEV-801."

Creatv’s LifeTracDx blood test isolates Cancer Associated Macrophage-Like Cells (CAMLs) and Circulating Tumor Cells (CTCs) using Creatv’s CellSieveTM microfilters to develop companion diagnostics to monitor drug targets and provide information on patient treatment response.

Dr. Cha-Mei Tang, President and CEO of Creatv Bio added, "Our partnership with Neovia Oncology LLC has the potential to advance the future of cancer diagnosis and treatment, thus saving and improving the lives of cancer patients."

(Press release, Neovia Oncology, JUN 2, 2026, View Source [SID1234666379])

On June 2, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) reported that at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held in Chicago, USA, the first-in-human study results of the novel B7-H3 ADC SKB500 in patients with advanced solid tumors were presented as a rapid oral report by Professor Liu Haifeng from Jilin Provincial Cancer Hospital (Abstract #3011|Molecularly Targeted Agents and Tumor Biology).

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SKB500 utilizes an antibody with high affinity, high hydrophilicity, and enhanced endocytosis, and has been engineered to silence Fc effector function in the constant region. Moreover, the antibody is conjugated to a payload with moderate toxicity via a cleavable hydrophilic AAA linker, with a drug-to-antibody ratio (DAR) of approximately 8.

The study was divided into three stages: dose escalation, dose expansion, and indication expansion, enrolling a total of 192 patients, including those with small cell lung cancer (SCLC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), colorectal cancer (CRC), neuroendocrine carcinoma (NEC), and other tumors. Patients received SKB500 at doses ranging from 2 to 18 mg/kg every three weeks (Q3W), with dose expansion and indication expansion conducted at 12 mg/kg and 16 mg/kg.

As of March 31, 2026, efficacy data showed:

Antitumor activities were observed across multiple solid tumor types, including SCLC, ESCC, HNSCC, pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and nasopharyngeal carcinoma (NPC). Among 124 patients treated at 12 mg/kg with at least 6 weeks of follow-up, the objective response rate (ORR) was 42.7%, and the disease control rate (DCR) was 83.9%.
Among the treated SCLC patients (n=40), the ORR was 65.0% (95% CI: 48.3, 79.4), median progression-free survival (mPFS) was 7.2 months (95% CI: 4.3, NE), DCR was 95.0%, and mDOR was 5.8 months.
Among the treated ESCC patients (n=37), the ORR was 54.1%.
In terms of safety, compared to the 16 mg/kg group, the 12 mg/kg group demonstrated a more favorable safety profile, characterized by a lower incidence of grade ≥3 treatment-related adverse events (TRAEs) and treatment-related serious adverse events (TRSAEs), as well as a low rate of permanent discontinuation. In the 12 mg/kg group, the incidence of grade ≥3 TRAEs was 32.3%, most commonly hematologic events.

The study demonstrates that SKB500 exhibits broad-spectrum antitumor activity, with responses observed in multiple treated advanced solid tumors including SCLC, ESCC, HNSCC, and PDAC, with notable efficacy in SCLC patients. At the 12 mg/kg group, SKB500 showed a favorable safety profile, where there was a low incidence of permanent discontinuation and no treatment-related deaths.

Professor Liu Haifeng, Principal Investigator from Jilin Provincial Cancer Hospital, said: "The positive results from this first-in-human study of SKB500 not only preliminarily confirm its favorable efficacy and manageable safety profile as a novel B7-H3 ADC, but also suggest its therapeutic potential in multiple solid tumors—offering particular hope for SCLC, a disease that is highly aggressive and has limited later-line treatment options. These findings lay a solid foundation for further clinical development. We look forward to further validating its clinical value in subsequent trials."

About SKB500

SKB500 is a novel B7-H3-targeted ADC independently developed by the company using its OptiDC platform technology, featuring a site-specific cleavable linker and a potent topoisomerase I inhibitor. In the Phase I clinical study, SKB500 demonstrated robust efficacy and manageable safety profiles across multiple advanced solid tumors. Currently, a Phase II exploratory study of SKB500 in combination with immunotherapy with or without chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) is ongoing in China.

(Press release, Kelun, JUN 2, 2026, View Source [SID1234666378])

On June 2, 2026 Astrazeneca reported positive results from the Phase III SERENA-6 trial showed camizestrant plus a cyclin-dependent kinase (CDK) 4/6 inhibitor – palbociclib, ribociclib or abemaciclib – maintained its progression-free survival (PFS) benefit with longer follow-up and delivered a statistically significant and clinically meaningful improvement in second progression-free survival (PFS2), demonstrating sustained benefit beyond initial treatment. Additionally, exploratory analyses showed that the camizestrant combination profoundly reduced total circulating tumour DNA (ctDNA) and enabled substantially more patients to achieve total ctDNA clearance.

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The trial evaluated switching to the camizestrant combination before progression in the 1st-line setting versus continuing standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor following detection of an ESR1 mutation in patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer.

SERENA-6 met its primary endpoint of PFS at the interim analysis, with results first presented at last year’s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and simultaneously published in The New England Journal of Medicine.1 The updated results will be presented today during the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, IL (abstract LBA1007).

The updated results showed the camizestrant combination reduced the risk of disease progression or death by 55% versus an AI plus a CDK4/6 inhibitor (based on a hazard ratio [HR] of 0.45; 95% confidence interval [CI] 0.34-0.59; p<0.00001). Median PFS was 16.8 months for the camizestrant combination compared with 9.2 months for the AI combination, representing a median improvement of 7.6 months.

Importantly, the PFS benefit observed with the camizestrant combination was sustained beyond initial progression. For the key secondary endpoint of PFS2, a measure of treatment durability beyond first progression, the final PFS2 analysis showed that the camizestrant combination reduced the risk of second disease progression or death by 37% versus the comparator arm (HR 0.63; 95% CI 0.46-0.86; p=0.00373), indicating that the benefit of switching to camizestrant plus a CDK4/6 inhibitor was maintained even after patients received subsequent therapies.​ Median PFS2 was 25.7 months for the camizestrant combination compared with 19.1 months for the AI combination.

The camizestrant combination also demonstrated substantially greater reductions in total ctDNA in blood than continued treatment with an AI plus a CDK4/6 inhibitor at week 4 and/or week 8 after randomisation. Patients who switched to the camizestrant combination had a median 99% reduction in total ctDNA by week 8, with 51% achieving total ctDNA clearance, compared with a median 64% increase in total ctDNA by week 8, and 1.9% total ctDNA clearance among patients who remained on the AI combination. These results show the early effect of switching to camizestrant on ctDNA which is linked to tumour burden reduction.

Clearance of total ctDNA during treatment has been associated with long-term clinical benefit including improved overall survival (OS) across tumour types, including in patients with HR-positive, HER2-negative advanced breast cancer receiving endocrine-based therapy plus a CDK4/6 inhibitor.2,3 In an exploratory analysis pooled across both arms in SERENA-6, total ctDNA clearance was associated with OS benefit (HR 0.39; 95% CI 0.19-0.73), consistent with other studies.

Data for the key secondary endpoint of OS showed a numerical trend favouring the camizestrant combination (HR 0.87; CI 0.57-1.30) at 30% maturity. ​The trial will continue to final analysis to assess OS.

François-Clément Bidard MD, PhD, Professor of Medical Oncology at Institut Curie & Versailles University (Paris/Saclay) France and co-principal investigator for the trial, said: "Optimising outcomes for patients with HR-positive advanced breast cancer early in their treatment is critical because once the disease progresses, it becomes harder to treat and outcomes worsen. The updated SERENA-6 results support the paradigm of switching to a camizestrant-based combination in the first-line setting upon emergence of an ESR1 mutation and demonstrate durable improvements beyond initial treatment. These results should change how we approach treating patients with HR-positive disease in the first-line setting."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "More than half of patients who switched to the camizestrant combination completely cleared tumour DNA from their bloodstream compared to two per cent with standard of care. This provides robust evidence that an early treatment switch has strong anti-tumour efficacy, and supports the potential for long-term clinical benefit. Switching to the camizestrant combination also extended the time patients lived without disease progression after first- and second-line treatment, delayed the need for more intensive therapies, and helped patients maintain their quality of life. Together, these results add to the growing data supporting the potential of the camizestrant combination to improve outcomes for these patients with advanced breast cancer."

Summary of results: SERENA-6 at ASCO (Free ASCO Whitepaper) 2026

Camizestrant + CDK4/6 inhibitor

AI + CDK4/6 inhibitor

PFSi

Number of patients (n)

157

158

Median PFS (months)

16.8 (14.7-19.4)

9.2 (7.2-9.7)

24-month PFS rate

34.9%

14.2%

Hazard ratio (95% CI)

0.45 (0.34-0.59)

p-value

p<0.00001

PFS2ii

Number of patients (n)

157

158

Median PFS2 (months)

25.7 (20.4-30.3)

19.1 (16.8-21.0)

24-month PFS2 rate

50.8%

36.3%

Hazard ratio (95% CI)

0.63 (0.46-0.86)

p-value

p=0.00373

OSiii

Events, n (%)

46 (29.3)

49 (31.0)

Hazard ratio (95% CI)

0.87 (0.57-1.30)

Change in total ctDNA

Median change from baseline at week 8

-99%

+64%

Total ctDNA clearanceiv

Number of patients with clearance/total analysed

50/98

2/108

Patients with total ctDNA clearance (%)

51.0

1.9

CI, confidence interval; HR, hazard ratio; PFS, progression-free survival; PFS2, progression-free survival 2; OS, overall survival

i PFS was defined per RECIST v1.1. HR was estimated using a Cox proportional hazards model adjusted for stratification factors
ii PFS2 was defined as time from randomisation to the earliest of disease progression following first subsequent therapy or death; results represent final PFS2 analysis
iii Intent-to-treat patient population; maturity was 30%
iv ctDNA clearance defined as the transition from quantifiable total ctDNA at baseline by Guardant360 assay to undetectable ctDNA after treatment at Week 4 and/or Week 8

Additional analyses showed that the camizestrant combination delayed the need for more intensive subsequent treatment, including chemotherapy or antibody-drug conjugates (ADCs). Median chemotherapy/ADC-free survival was 22.6 months for the camizestrant combination versus 18.7 months for the AI combination (HR 0.64; 95% CI 0.47-0.87; p=0.00375). The camizestrant combination was also associated with delayed deterioration in patient-reported cancer symptoms such as pain, global health status and quality of life.

The safety profile of camizestrant in combination with palbociclib, ribociclib or abemaciclib in the SERENA-6 trial was consistent with the known safety profile of each medicine. No new safety concerns were identified, and discontinuations were very low and similar in both arms.

Camizestrant is approved in the United Arab Emirates and Saudi Arabia based on the SERENA-6 trial. The European Medicines Agency’s Committee for Medicinal Products for Human Use recently adopted a positive opinion recommending approval of the camizestrant combination in the European Union based on the results of the SERENA-6 Phase III trial.

Regulatory applications are also currently under review in the US, Japan and several other countries. The US Food and Drug Administration last week extended the Prescription Drug User Free Act date to review the updated results from the SERENA-6 trial.

Notes

HR-positive breast cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.4 More than two million patients were diagnosed with breast cancer in 2022, with more than 665,000 deaths globally.4 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.5

HR-positive breast cancer, characterised by the expression of estrogen or progesterone receptors, or both, is the most common subtype of breast cancer with 70% of tumours considered HR-positive and HER2-negative.5 More than 97% of HR-positive breast cancer tumours are estrogen receptor (ER)-positive. ERs often drive the growth of HR-positive breast cancer cells.6

Globally, approximately 200,000 patients with HR-positive breast cancer are treated with a medicine in the 1st-line setting; most frequently with endocrine therapies that target ER-driven disease, which are often paired with CDK4/6 inhibitors.7-9 However, resistance to these therapies develops in many patients.9 Once this occurs, treatment options are limited and survival rates are low with approximately 36% of patients anticipated to live beyond five years after diagnosis.5,9

Mutations in the ESR1 gene are a key driver of endocrine resistance and are associated with poor outcomes, emerging during treatment of the disease and becoming more prevalent as the disease progresses.10,11 Approximately 30% of patients with endocrine sensitive HR-positive disease develop ESR1 mutations during 1st-line treatment before disease progression.7

The optimisation of endocrine therapy and overcoming resistance to enable patients to continue benefiting from these treatments, as well as identifying new therapies for those who are less likely to benefit, are active areas of focus for breast cancer research.

SERENA-6
SERENA-6 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) versus treatment with an AI (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in patients with HR-positive, HER2-negative advanced breast cancer (patients with either locally advanced disease, or metastatic disease) whose tumours have an emergent ESR1 mutation.

The global trial enrolled 315 adult patients with histologically confirmed HR-positive, HER2-negative advanced breast cancer, undergoing treatment with an AI in combination with a CDK4/6 inhibitor as 1st-line treatment. The primary endpoint of the SERENA-6 trial is PFS as assessed by investigator, with secondary endpoints including OS, and PFS2 by investigator assessment.

SERENA-6 is the first global, registrational Phase III trial to use a circulating tumour DNA (ctDNA)-guided approach to detect the emergence of endocrine resistance and inform a switch in therapy before disease progression. The innovative trial design used ctDNA monitoring via a blood test at the time of routine tumour scans every two to three months to identify patients for early signs of endocrine resistance via the emergence of ESR1 mutations. Following detection of an ESR1 mutation without disease progression, the endocrine therapy of patients was switched to camizestrant from ongoing treatment with an AI, while continuing combination with the same CDK4/6 inhibitor.

Camizestrant
Camizestrant is an investigational, potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist that is currently in Phase III trials for the treatment of HR-positive breast cancer.

AstraZeneca’s broad, robust and innovative clinical development programme, including the SERENA-6, SERENA-4, CAMBRIA-1 and CAMBRIA-2 trials, is evaluating the safety and efficacy of camizestrant when used as a monotherapy or in combination with CDK4/6 inhibitors to address a number of areas of unmet need in HR-positive, HER2-negative breast cancer.

Camizestrant has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. In the SERENA-2 Phase II trial, camizestrant demonstrated a statistically significant and clinically meaningful improvement in PFS versus Faslodex (fulvestrant) in the overall trial population, including in patients with ESR1 tumour mutations irrespective of prior treatment with CDK4/6 inhibitors in patients with ER-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy. The SERENA-1 Phase I trial demonstrated that camizestrant is well tolerated and has a promising anti-tumour profile when administered alone or in combination with palbociclib, ribociclib and abemaciclib; three widely used CDK4/6 inhibitors.

(Press release, AstraZeneca, JUN 2, 2026, https://www.astrazeneca.com/media-centre/press-releases/2026/camizestrant-combination-delayed-time-to-first-progression-in-patients-with-advanced-hr-positive-breast-cancer-with-an-ESR1-tumour-mutation.html [SID1234666377])

On June 2, 2026 Lantern Pharma Inc. (NASDAQ: LTRN), an AI-driven precision oncology company, reported clinical data and updates in the form of a presentation from its ongoing Phase 2 HARMONIC trial (NCT05456256) evaluating LP-300 in combination with carboplatin and pemetrexed in patients with EGFR Exon 21 L858R-mutant non-small cell lung cancer (NSCLC) who have progressed following TKI-based therapy. The emerging dataset (data cutoff May 11, 2026) reveals a coherent pattern: the progression-free survival benefit of LP-300 deepens with treatment duration, and the signal is most pronounced in the L858R subgroup — a molecularly defined population with a poor prognosis and limited options following frontline TKI therapy. The Company has furnished the presentation and slides as an exhibit to a Current Report on Form 8-K filed today, and is using the updated data and slides for partnering and clinical discussions during ASCO (Free ASCO Whitepaper) 2026 in Chicago.

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"What we are seeing is an early signal that strengthens the longer the biomarker specific patients remain on therapy, and very importantly no notable changes in the exceptionally clean safety and tolerability profile for LP-300," said Panna Sharma, CEO & President of Lantern Pharma. "These patient observations and clinical benefit patterns provide the rationale behind the recently FDA-cleared protocol amendment extending LP-300 dosing from a maximum of six to eight cycles, and reinforces the Company’s focus on the highly undermet need for the L858R patient subgroup – which is about 40% of EGFR mutated patients globally."

A Deepening Signal: Benefit Concentrates with Treatment Duration

A key finding and early observation emerging from HARMONIC is the relationship between treatment duration and depth of benefit. Patients who received up to six cycles of LP-300 derived greater progression-free survival benefit than those treated for fewer cycles, and within the L858R subgroup this duration effect was most evident — a median PFS of 8.9 months in patients treated through up to six cycles, against 8.4 months in the overall L858R cohort (n=15).

The L858R subgroup also corresponded to a hazard ratio of 0.37 (95% CI 0.15–0.89) favoring L858R. The directional trend toward longer PFS with additional cycles provides the basis for extending treatment duration to eight cycles.

Depth and Durability of Response

Beyond the duration relationship, the data point to durable disease control in the L858R population. More than 70% of evaluable L858R patients experienced a reduction in target-lesion size — including a complete response and multiple partial responses among the deepest responders — and durable responses were sustained beyond two years in select patients. The L858R cohort showed a 77% clinical benefit rate, consistent with the depth and durability observed across the response data.

8.9 mo

Median PFS — L858R, up to 6 cycles

>70%

Evaluable L858R patients with tumor reduction

2+ yrs

Durable responses in select L858R patients

77%

Clinical benefit rate — L858R cohort

In a multivariable Cox proportional-hazards analysis, L858R remained significantly and independently associated with PFS benefit after adjustment for race and gender (hazard ratio 0.36; 95% CI 0.15–0.90; p=0.028), with the association persisting when adjusting for TP53 mutation status. These analyses are exploratory and based on a small cohort; they are intended to characterize the emerging signal and inform the enriched study design – which Lantern is pursuing going forward – rather than to establish efficacy.

A Consistently Clean Safety Profile Supports Extended Treatment

Critically, the deepening efficacy signal is accompanied by a tolerability profile that supports longer treatment durations. Across patients treated with LP-300 plus chemotherapy (N=31), LP-300 added no clinically meaningful toxicity beyond the carboplatin/pemetrexed backbone. On a cross-trial basis — provided for context only and not a head-to-head comparison — LP-300 plus chemotherapy compared favorably with the FDA-approved amivantamab-plus-chemotherapy regimen reported in the Phase 3 MARIPOSA-2 study (Passaro A, et al. Ann Oncol 2024), particularly on the administration-burden and dermatologic toxicities that most limit sustained treatment in heavily pre-treated patients:

Adverse Event (any grade unless noted)

LP-300 + Chemo (N=31)

Amivantamab + Chemo (N=130)¹

Treatment-related serious adverse event

3%

23%

TEAE leading to dose delay (any study drug)

19%

65%

TEAE leading to drug discontinuation

6%

18%

Infusion-related reaction (TRAE)

7%

58%

Rash (TRAE)

7%

43%

Paronychia (TRAE)

0%

36%

Stomatitis (TRAE)

0%

31%

¹ Cross-trial comparison; not a head-to-head study. Amivantamab + chemotherapy data from Passaro A, et al. Annals of Oncology 2024;35(1):77–90 (MARIPOSA-2). LP-300 + chemotherapy data are preliminary; HARMONIC data cutoff May 11, 2026.

Competitive Context: Comparable Efficacy, Differentiated Tolerability

Amivantamab plus chemotherapy is FDA-approved in the post-osimertinib setting and represents the current benchmark in this space, with a reported 9.7-month median PFS in L858R patients. LP-300’s emerging profile is positioned not as a claim of superior anti-tumor efficacy, but as a comparable efficacy range with a substantially more favorable safety, tolerability, and administration profile — highly relevant in a heavily pre-treated population where tolerability drives real-world outcomes such as quality of life, reduced costs and reduced clinical burden.

Regimen

ORR

mPFS

Key Tolerability Profile

LP-300 + Carboplatin + Pemetrexed (HARMONIC — L858R enriched)

43%*

8.4 mo* (6.2–NE)

8.9 mo**

Grade 1–2 predominant; no new added toxicity vs. chemo; 3% serious TRAEs

Amivantamab + Chemo (MARIPOSA-2) [FDA-approved, post-osimertinib] (L858R patients)

36%

9.7 mo (5.9–11.3)

23% serious TRAEs; 58% infusion reactions; 36% paronychia

Carboplatin + Pemetrexed alone (historical standard of care)

27–36%

4.2–5.5 mo

Standard chemotherapy toxicities

*Preliminary data. ORR derived from the initial safety lead-in (n=7); HARMONIC mPFS from the L858R-enriched cohort (n=31, data cutoff May 11, 2026). **Patients who received up to six cycles. All comparisons are cross-trial and not head-to-head. NE = not estimable.

Featured for Partnering and Clinical Discussions During ASCO (Free ASCO Whitepaper) 2026

The convergence of a duration-dependent efficacy signal with a clean, sustainable safety profile carries a clear strategic implication: patients can be treated longer, and longer treatment appears to deepen benefit. This relationship underpins the recently FDA-cleared amendment extending LP-300 dosing to eight cycles and the Company’s decision to concentrate enrollment on the L858R subgroup. Lantern Pharma has furnished the accompanying slides on Form 8-K and is using the updated dataset for partnering and clinical discussions during ASCO (Free ASCO Whitepaper) 2026 in Chicago, including potential global and regional licensing and co-development opportunities in never-smoker NSCLC. The Company expects to report additional data as the enriched L858R cohort matures.

LP-300 Shaped & Supported By Lantern’s AI Platform For Drug Development

Indication development and refinement for LP-300 were in part supported by early observations from prior trials and large scale differential gene expression and mutational analysis across NSCLC data sets. Panna Sharma commented, "Our LP-300 program reflects a data-driven, AI-powered approach to understanding how a previously overlooked molecule could meaningfully serve the needs of L858R NSCLC patients — a population that has consistently underperformed on existing therapies. The convergence of molecular modeling, high-resolution biology, and biomarker-driven patient selection is fundamentally changing what is possible for precision oncology drug developers, and we believe LP-300 is well positioned at that intersection."

About the HARMONIC Trial

HARMONIC (NCT05456256) is a Phase 2 clinical trial investigating LP-300 in combination with pemetrexed and carboplatin in never/non-smoker patients with advanced lung adenocarcinoma that has progressed following prior TKI therapy. The trial has enrolled in the United States, Taiwan, and Japan. Primary endpoints are progression-free survival and overall survival; secondary endpoints include objective response rate, duration of response, and clinical benefit rate.

About LP-300

LP-300 is a small-molecule investigational agent with a multimodal mechanism of action, including receptor tyrosine kinase modulation and redox regulation. It has been administered to more than 1,000 individuals across prior clinical studies. LP-300 is being developed using insights from Lantern’s proprietary RADR AI platform. LP-300 has not received marketing approval from the FDA or any other regulatory authority for any indication.

(Press release, Lantern Pharma, JUN 2, 2026, View Source [SID1234666376])