Bridget Hoyt

An LED-based intraoral device was safe and reduced severe oral mucositis and throat pain in patients receiving radiotherapy for head and neck cancers.

An LED-based intraoral device for photobiomodulation therapy appeared safe and reduced severe oral mucositis versus a placebo procedure for patients with head and neck cancers receiving radiotherapy, according to data from a trial presented at the 2025 ASTRO Annual Meeting.

Patients receiving active photobiomodulation therapy experienced 70% and 3% relative reductions in severe oral mucositis at two weeks post treatment and six weeks of radiotherapy, respectively, compared with placebo.

At six weeks of radiotherapy, 36.8% of the active arm had grade 3 (severe) or 4 (life-threatening) oral mucositis versus 57.1% in the placebo arm. Likewise, 10.8% of the active arm had grade 3 or 4 oral mucositis two weeks after radiotherapy versus 36.4% in the placebo arm.

Additionally, patient-reported outcomes reflected that participants who received photobiomodulation therapy experienced significantly less increased mouth and throat soreness, with a score of 1.5 out of 5 in the arm receiving photobiomodulation therapy and 2.2 in the group receiving the placebo.

Throat pain was also reduced in the active arm, with a score of 3.8 out of 10 compared with 5.3 in the placebo arm. Scores for mouth and throat soreness and throat pain were taken from the validated patient-reported outcome tool Oral Mucositis Weekly Questionnaire.

Patients beginning cancer treatment without previous placement of a percutaneous endoscopic gastrostomy (PEG) feeding tube saw a 59% reduction in PEG placements; 15.2% of patients in the active arm has PEG placements versus 37% in the placebo arm.

No device-related adverse events were found in patients receiving active photobiomodulation therapy, and 2574 out of 2619 sessions (98.3%) were completed in full.

What Patients Were Eligible for Photobiomodulation Therapy and How Much Did They Receive?

The prospective, double-blind, sham-controlled trial, which was randomized 1:1, took place across 12 cancer centers, with 85 participants completing the trial. Patients underwent a continuous course of intensity-modulated radiation therapy (IMRT) for six to eight weeks, including some patients who received concurrent chemotherapy.

Patients were eligible if they received more than 50 Gy of radiation in at least two oral cavity sites, with a maximum cumulative 70 Gy of radiation. Patients were allowed to use pain medications and oral mouthwashes.

Participants received daily 10-minute photobiomodulation therapy at 660 nm, 6 J/cm

 for 10 minutes immediately before radiation therapy along with daily and weekly assessments. Investigators followed up with patients two weeks after treatment concluded. Patients received 30 to 40 device sessions, dependent on the standard of care regimen by cancer type.

Those receiving the sham procedure had the placebo device placed in their mouth and operated as if it delivered photobiomodulation therapy without delivering active therapy. Regardless of assignment to the active or placebo arm, patients were kept on standard protocols for oral care, oral pain, and oral hygiene. Participants were required to wear light-blocking eyewear during active or placebo treatment.

The primary outcome measured was severity of oral mucositis at week six of radiation therapy measured with the Oral Mucositis Index, and secondary outcomes measured included World Health Organization Oral toxicity scale at week six and changes in overall quality of life over the six-week treatment period

As researchers outlined in the study’s abstract, the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) recommend photobiomodulation (PBM) therapy as an option to reduce or prevent mucositis in patients undergoing radiotherapy for head and neck cancers.

Photobiomodulation can promote wound healing by using non-ionizing light in the visible and near-infrared light spectra to alter biological systems.

“Safety and efficacy of an LED-based intraoral device for daily photobiomodulation therapy prior to cancer treatment for reducing severity of oral mucositis in head and neck cancer patients” by Dr. Hu, et al., Presented at ASTRO’s 67th Annual Meeting.

“Photobiomodulation to demonstrate safety and reduce the incidence of oral mucositis in adult head and neck cancer patients” by Dr. Hu, et al., ClinicalTrials.gov.

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Articles

An LED-based intraoral device for photobiomodulation therapy demonstrated safety and efficacy in reducing severe oral mucositis in head and neck cancer patients undergoing radiotherapy. The trial showed significant reductions in severe oral mucositis and PEG tube placements in the active treatment group compared to placebo. Patient-reported outcomes indicated less mouth and throat soreness and reduced throat pain in the active arm. The trial was a double-blind, sham-controlled study conducted across 12 cancer centers, with participants receiving daily photobiomodulation therapy sessions before radiation therapy.

Photobiomodulation Device Cuts Oral Mucositis in Head and Neck Cancer

The FDA granted priority review to an sBLA for first-line treatment with Enhertu plus Perjeta in unresectable or metastatic HER2-positive breast cancer.

The U.S. Food and Drug Administration (FDA) has granted priority review to a supplemental biologics license application for first-line treatment with Enhertu (fam-trastuzumab deruxtecan-nxki; T-DXd) plus Perjeta (pertuzumab) for adults with unresectable or metastatic HER2-positive breast cancer, according to a news release from AstraZeneca.

“The DESTINY-Breast09 trial showed that treating patients with HER2-positive metastatic breast cancer with Enhertu in combination with [Perjeta] until progression in the first-line setting produced a new landmark of more than 40 months for progression-free survival and nearly doubled the number of patients with no evidence of disease on imaging,” Susan Galbraith, executive vice president of Oncology Haematology R&D at AstraZeneca, said in the news release. “This marks the first major evolution in treatment in this first-line setting in more than a decade — a setting where a strong response is crucial, as up to one-third of patients may not receive second-line therapy.”

Priority review status means the FDA will review the application more quickly than usual, as the combination therapy may provide meaningful improvements compared with current standard options.

A regulatory decision is expected during the first quarter of 2026. For patients, this means there may soon be an earlier opportunity to access a promising therapy that could help delay disease progression.

In addition to priority review, the FDA also granted breakthrough therapy designation to Enhertu plus Perjeta in this treatment setting. Breakthrough therapy designation is designed to accelerate the development and review of medicines that address serious conditions and meet an unmet medical need.

The FDA’s review is based on results from the phase 3 DESTINY-Breast09 trial. This study compared Enhertu plus Perjeta with the current standard treatment of a taxane chemotherapy, Herceptin (trastuzumab), and Perjeta — altogether referred to as THP — in patients receiving therapy for HER2-positive metastatic breast cancer for the first time.

Results showed that Enhertu plus Perjeta reduced the risk of disease progression or death by 44% compared with THP. Median progression-free survival was more than three years (40.7 months) for patients treated with the Enhertu-based approach, compared with 26.9 months for patients who received THP.

The benefits of Enhertu plus Perjeta were consistent across patient subgroups. The confirmed objective response rate was also higher in the Enhertu group at 85.1% compared with 78.6% with THP. Complete responses were achieved by 58 patients on Enhertu plus Perjeta compared to 33 on THP.

The safety profile of Enhertu plus Perjeta was consistent with what is already known for each therapy. No new safety concerns were identified, which suggests the combination can be given safely.

Will Enhertu Plus Perjeta Change the Standard of Care?

HER2-positive metastatic breast cancer is an aggressive form of the disease caused by the overexpression or amplification of the HER2 protein, the news release explained. It affects an estimated 15% to 20% of patients with metastatic breast cancer. Until now, THP has been the standard first-line regimen for more than a decade. However, the results from DESTINY-Breast09 suggest Enhertu plus Perjeta may offer a more effective option.

“Enhertu in combination with [Perjeta] delayed disease progression for more than three years compared with around two years with current standard of care as a first-line treatment for patients with HER2-positive metastatic breast cancer,” Ken Takeshita, global head of R&D at Daiichi Sankyo, added in the news release. “Receiving priority review moves us closer to offering Enhertu to patients even earlier in the metastatic treatment pathway as a potential new first-line treatment option.”

Notably, Enhertu, a HER2-directed antibody drug conjugate, is already approved in more than 85 countries as a second-line treatment for HER2-positive breast cancer based on results from the DESTINY-Breast03 trial. If the FDA approves this new first-line indication, Enhertu plus Perjeta may become the next standard of care for patients facing HER2-positive metastatic breast cancer, the news release concludes.

“ENHERTU® (fam-trastuzumab deruxtecan-nxki) plus pertuzumab granted Priority Review in the US as 1st-line treatment for patients with HER2-positive metastatic breast cancer,” by AstraZeneca. News release; Sept. 24, 2025.

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The FDA has granted priority review to a supplemental biologics license application for Enhertu plus Perjeta as a first-line treatment for unresectable or metastatic HER2-positive breast cancer. The DESTINY-Breast09 trial demonstrated significant improvements in progression-free survival and objective response rates compared to the current standard of care. Enhertu plus Perjeta reduced the risk of disease progression or death by 44% and showed a consistent safety profile. If approved, this combination could become the new standard of care, offering a more effective treatment option for patients with HER2-positive metastatic breast cancer.

First-Line Enhertu Combo Gets Priority Review in HER2+ Metastatic Breast Cancer

The FDA has approved Inlexzo for adults with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.

The U.S. Food and Drug Administration (FDA) has approved Inlexzo (gemcitabine intravesical system) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors, the agency announced, noting that the system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder.

The treatment’s effectiveness was determined in cohort 2 of the SunRISe-1 trial, which enrolled 83 patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors following transurethral resection, with patients receiving Inlexzo into the bladder every three weeks for six months, followed by once every 12 weeks for up to 18 months.

The system delivers 225 mg of gemcitabine chemotherapy into the bladder, with an indwelling period following each insertion of three weeks prior to removal, and the system is inserted once every three weeks for up to six months, or eight doses, and then once every 12 weeks for up to 18 months, or six doses), or until persistent or recurrent high-grade NMIBC, disease progression or unacceptable toxicity.

The treatment, previously known as TAR-200, was granted priority review by the 

Tumor status, as stated in the FDA’s announcement, was assessed via cystoscopy and urine cytology every 12 weeks during the initial two years of treatment, after which cystoscopy was performed at least every 24 weeks, and biopsies were performed at 24 and 48 weeks after treatment initiation.

 and 51% of patients with a complete response had a duration of response of at least one year.

The treatment’s prescribing information, the FDA noted, includes warnings and precautions describing the risks of administering gemcitabine intravesical system in patients with a perforated bladder, risk of metastatic bladder cancer with delayed cystectomy, magnetic resonance imaging (MRI) safety and embryo-fetal toxicity.

“I see many patients that ultimately become BCG-unresponsive and often face life-altering bladder removal. These patients now may be ideal candidates for newly approved Inlexzo,” said Dr. Sia Daneshmand, principal investigator of the clinical trial and professor of urology and director of urologic oncology at the Norris Comprehensive Cancer Center, Keck School of Medicine of University of Southern California, in a statement included in a news release from Johnson & Johnson. “In my experience, Inlexzo is well-tolerated and delivers clinically meaningful results. This will change the way we treat appropriate patients that haven’t responded to traditional therapy.”

“We are proud of the science that has brought us to this historic moment,” said Dr. John Reed, executive vice president of R&D, Innovative Medicineat Johnson & Johnson, in the news release. “Inlexzo is a novel therapy with powerful efficacy and demonstrated safety profile. As the only major healthcare company that hosts both pharmaceuticals and medical devices, we leveraged the speed and scale of Johnson & Johnson to accelerate innovation and deliver this important therapy to patients."

“At BCAN, our mission has always been to advocate for better todays and more tomorrows for everyone impacted by bladder cancer. This approval represents the kind of progress that brings new options to a community that urgently needs them,” said Meri-Margaret Deoudes, CEO, Bladder Cancer Advocacy Network (BCAN), in the news release. “Patients with bladder cancer need guidance and collaboration with providers to navigate bladder-sparing treatment options, including newly approved treatments like Inlexzo, so they can move forward feeling well-informed and confident.”

For more news on cancer updates, research and education, 

“FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer,” FDA; https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer?check_logged_in=1

“U.S. FDA approval of INLEXZO™ (gemcitabine intravesical system) set to transform how certain bladder cancers are treated,” news release, Sept. 9, 2025; https://www.multivu.com/johnson-and-johnson/9342851-en-johnson-and-johnson-fda-approval-inlexzo-gemcitabine-intravesical-system

The FDA has approved Inlexzo (gemcitabine intravesical system) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. The approval is based on the SunRISe-1 trial, which demonstrated an 82% complete response rate. Inlexzo is administered intravesically every three weeks for six months, then every 12 weeks for up to 18 months. The treatment is well-tolerated and offers a new option for patients who have not responded to traditional therapies, potentially avoiding bladder removal.

FDA Approves Inlexzo for Some With Non–Muscle Invasive Bladder Cancer

For some with previously untreated locally advanced or metastatic non-small cell lung cancer Rybrevant plus Lazcluze improved overall survival.

Among patients with previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution mutations, treatment with Rybrevant (amivantamab) plus Lazcluze (lazertinib) was found to result in a statistically significant and clinically meaningful improvement in overall survival versus treatment with Tagrisso (osimertinib) monotherapy, study results have shown.

Results from the phase 3 MARIPOSA study were published in 

 and announced in a news release from Janssen-Cilag International NV, a Johnson & Johnson company.

At a median follow-up time of 37.8 months, the treatment combination of Rybrevant and Lazcluze was associated with a 25% lower risk of death than treatment with Tagrisso. The news release noted that the median overall survival time for the combination is expected to exceed four years versus the median overall survival time of 36.7 months observed with Tagrisso monotherapy.

Overall survival: the time a patient lives, regardless of disease status.

Progression-free survival: the time a patient lives without their disease spreading or worsening.

Paronychia: skin infection around the nail.

“This is a turning point in how we treat EGFR-mutated lung cancer,” said Dr. James Chih-Hsin Yang of the Department of Medical Oncology at the National Taiwan University Cancer Center in Taipei, Taiwanin the news release. “We’re now seeing the potential for patients to live significantly longer than we thought possible. Starting with [Rybrevant] plus [Lazcluze] may prevent common types of resistance and reserves chemotherapy for later lines of therapy, which can help achieve better outcomes.”

Yang was the lead author of the MARIPOSA study.

“These published data further reinforce the potential of the chemotherapy-free, dual-targeted [Rybrevant] plus [Lazcluze] regimen to deliver meaningful, long-term clinical outcomes and experiences for patients and their families versus the current standard of care,” said Henar Hevia, senior director of and head of EMEA Therapy Area for oncology at Johnson & Johnson Innovative Medicine.

Among patients who received the treatment combination, the median time to subsequent therapy was 30.3 months versus 24 months with Tagrisso. The combination was also associated with improved progression-free survival after subsequent therapy, with times of 42.9 months versus 32.8 months in the Rybrevant and Tagrisso treatment groups, respectively.

“With these results, we have the potential to change the trajectory of this disease,” said Dr. Joshua Bauml, vice president and disease area leader of lung cancer at Johnson & Johnson Innovative Medicine. “Unmet needs remain high for people living with EGFR-mutated lung cancer. Now, we’re delivering survival outcomes that have the ability to redefine what first-line treatment can achieve.”

The combination’s safety profile was reportedly consistent with the primary analysis, with the most common treatment-related side effects of any grade being paronychia (69%), infusion-related reaction (65%) and rash (64%). The most common grade 3 (severe) or worse side effects were rash (17%), paronychia (12%), dermatitis acneiform (9%), pulmonary embolism (9%) and alanine transaminase increase (7%).

Overall survival findings from MARIPOSA were 

 earlier this year in a presentation at the 2025 European Lung Cancer Congress, as well as published in a news release from Johnson & Johnson.

“Rybrevant plus Lazcluze helps patients live longer, and the benefit keeps growing over time,” trial investigator, Dr. Nicolas Girard, said in a news release issued at the time. “We see the gap between the survival curves continue to widen, which is exactly what we want to see in lung cancer treatment to improve outcomes for patients. These results reinforce that we are entering a new era for EGFR-mutated non-small cell lung cancer; with this evidence in hand, we need to ensure every patient gets the most effective treatment in the first line for the best possible chance at longer survival.”

Girard, who also presented these data at the meeting, is the head of Medical Oncology at the Institut Curie and a professor of Thoracic Oncology and Respiratory Medicine at the Paris-Saclay University, in France.

“Data published in The New England Journal of Medicine demonstrate RYBREVANT®(amivantamab) plus LAZCLUZE® (lazertinib) could re-set survival expectations in first-line EGFR-mutated advanced lung cancer,” news release, Sept.7, 2025; https://www.globenewswire.com/news-release/2025/09/07/3145711/0/en/Data-published-in-The-New-England-Journal-of-Medicine-demonstrate-RYBREVANT-amivantamab-plus-LAZCLUZE-lazertinib-could-re-set-survival-expectations-in-first-line-EGFR-mutated-advan.html

“First-line Rybrevant Combo Extends Survival in Advanced Lung Cancer,” CURE, March 31, 2025; 

https://www.curetoday.com/view/first-line-rybrevant-combo-extends-survival-in-advanced-lung-cancer

A combination therapy of Rybrevant (amivantamab) and Lazcluze (lazertinib) has shown significant improvement in overall survival for patients with untreated locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations, compared to Tagrisso (osimertinib) monotherapy. The phase 3 MARIPOSA study revealed a 25% reduction in mortality risk and extended median overall survival beyond four years. The combination also demonstrated improved progression-free survival and delayed the need for subsequent therapy. The safety profile was consistent, with manageable side effects.

Bridget Hoyt

Photobiomodulation Device Cuts Oral Mucositis in Head and Neck Cancer

First-Line Enhertu Combo Gets Priority Review in HER2+ Metastatic Breast Cancer

FDA Approves Inlexzo for Some With Non–Muscle Invasive Bladder Cancer

Rybrevant Plus Lazcluze Associated with Survival Improvement in NSCLC

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