Traditional Treatment Fails Some Elderly Head and Neck Cancer Patients, but NBTXR3 May Potentially Provide a New Option

3 June 2022

By Dr. Leonard A. Farber

For over 30 years, Beth Holtz worked from the sidelines, supporting her husband, legendary college football coach and Hall of Famer, Lou Holtz. What many people didn’t realize was that Holtz’s efforts off the field were even more herculean than those of any American football player, as for more than two decades, she was battling throat cancer.

During these many years, Holtz had radiotherapy (also called radiation therapy) treatments for her stage IV squamous cell carcinoma, a common type of cancer that accounts for 90 percent of all head and neck cancers.

The treatment would be aggressive. Radiotherapy, which uses high doses of radiation to destroy cancer cells, can also harm surrounding healthy tissues. Holtz, for example, was left with immense damage to the lining of her throat and esophagus that couldn’t be repaired. She also suffered xerostomia, or “dry mouth,” a common side effect experienced by many head and neck cancer patients who receive radiotherapy that impacts their ability to taste and enjoy food, swallow, and even speak.

Sadly, after her prolonged battle, the cancer metastasized (spread to other areas of the body) and she succumbed to the disease at 82 years old. Before her death, she underwent chemotherapy in addition to radiotherapy, which is the non-surgical standard of care. But many other elderly patients are too frail to undergo aggressive rounds of chemotherapy. This leaves them with limited treatment options, forcing many to focus more on palliative care rather than curative strategies or approaches.

But a new treatment option is being evaluated

Nanobiotix believes that tough-to-treat elderly patients with head and neck cancers deserve innovative treatment options that could potentially improve their survival outcomes. In fact, we believe all patients with head and neck cancers deserve such treatments. Our goal is to benefit many patients with these cancers using our lead product candidate (currently in phase III clinical trial), NBTXR3, which is injected directly into solid tumors and then activated by radiotherapy. After activation, NBTXR3, a radioenhancer, is designed to amplify the radiotherapy effects within the tumor cells where it is present, inducing significant tumor cell death without increasing the dose in surrounding healthy tissues.

What does traditional treatment entail for many head and neck cancer patients? Why does it fail some elderly patients? How could NBTXR3 potentially improve survival outcomes for patients, including those who are able to receive chemotherapy and those who cannot? Let’s find out.

The Nitty-Gritty of Head and Neck Cancer and Traditional Treatments

Well-known risk factors of head and neck cancer include tobacco and alcohol use. Another strong risk factor is a common sexually transmitted infection called HPV, or human papillomavirus.

Head and neck cancers can start in many places, including the larynx (voice box), mouth, tongue, throat, sinuses, or in a salivary gland.

Read <a href="https://www.nanobiotix.com/treatment-for-head-and-neck-cancer/">"What to Expect: From Diagnosis to Treatment for Head and Neck Cancer"</a> by Dr. Leonard A. Farber.</i>

Read "What to Expect: From Diagnosis to Treatment for Head and Neck Cancer" by Dr. Leonard A. Farber.

Symptoms can differ depending on where the cancer is located, but they may include a persistent sore throat, hoarseness, a slightly stuffy nose, or a lump, with or without pain.

Standard treatments for head and neck cancer include surgery, chemotherapy, radiation, targeted therapies, immunotherapies, or a combination of some or all of them. These treatments can be incredibly uncomfortable. Chemotherapy can cause some patients to experience hearing loss or neuropathy. Throw in radiotherapy, and some patients may have side effects including tooth decay, jaw stiffness, or, in Holtz’s case, a dry mouth, difficulty tasting food, and weight loss.

When Age Isn’t Just a Number

If diagnosed early, head and neck cancer is often treatable. Two-thirds of patients, however, have advanced to stages III or IV by the time they are diagnosed, which can lead to a poorer prognosis, including recurrence after surgery and metastasis, which is cancer that spreads to other areas of the body. For these patients, a five-year survival rate is less than 50 percent, meaning about half of them will die from their disease within five years.

Aging can add new complications to cancer treatment. First, cancer is more prevalent in older people — a lot more prevalent. Compared to younger individuals, there is an 11-fold increased chance of developing cancer for people older than 65. Patients 65 years and older account for over half of new head and neck squamous cell cancer diagnoses each year.

Why does the incidence rate increase so dramatically? The older a person gets, the higher the chance of developing comorbidities (two or more significant conditions at a time). The chance of having two or more serious conditions is 60 percent between the ages of 75 and 79, and this number skyrockets to 75 percent between 85 and 89.

The aging body can cause people to experience more side effects from drugs, including from cisplatin, a type of chemotherapy medication often used in combination with radiotherapy to treat head and neck squamous cell cancer.

Broad access to clinical trials in this population is challenging due to an increased prevalence of comorbidities and aging-related conditions. However, people around the world are living longer than ever before, and one in six people will be 60 or older by the year 2030. As the population-age increases, more and more elderly patients are diagnosed with head and neck cancer although many are not eligible to receive standard cisplatin-based concurrent chemoradiation. This means that chemoradiation-related toxicities, treatment burden, and compliance (sticking to a treatment regimen) are a growing concern.

NBTXR3 is Being Evaluated as a Head and Neck Cancer Treatment for Elderly Patients

Outcomes for elderly patients are generally worse than for younger patients – but does this need to be the case?

NANORAY-312 is a global phase III registration study evaluating the safety and efficacy of radiotherapy-activated NBTXR3 for high-risk elderly patients with locally advanced head and neck cancer who are ineligible for cisplatin.

We have seen data from our phase I head and neck cancer study suggesting that NBTXR3 may improve outcomes for elderly patients with an even worse prognosis than those being recruited for the phase III study. This study has shown a median overall survival of 23 months in evaluable patients and median progression free survival of 17.9 months in this patient group. Moreover, the administration of NBTXR3 was feasible and well-tolerated in a population with the burden of comorbidities and disease.

Addressing the needs of patients, including elderly, frail patients, is our number one priority. We will remain tireless in our efforts to bring the potential benefits of NBTXR3 to patients around the world so that they may live longer and continue spending time with their family and friends and do the things they enjoy.

Interested in learning more about NBTXR3 clinical studies? Please visit this page if you are a patient or this page if you are a healthcare provider and make sure to follow us on Twitter and LinkedIn.

Dr. Leonard A. Farber is the chief clinical and medical affairs officer at Nanobiotix.

Important Information Regarding Forward-Looking Statements

This post contains certain “forward-looking” statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “at this time,” “anticipate,” “believe,” “expect,” “intend,” “on track,” “plan,” “scheduled,” and “will,” or the negative of these and similar expressions. These forward-looking statements, which are based on our management’s current expectations and assumptions and on information currently available to management, include statements about the timing and progress of clinical trials, the timing of our presentation of data, the results of our preclinical and clinical studies and their potential implications, the development and commercialization of NBTXR3, and the execution of the Company’s development and commercialization strategy. Such forward-looking statements are made in light of information currently available to us and based on assumptions that Nanobiotix considers to be reasonable. However, these forward-looking statements are subject to numerous risks and uncertainties, including with respect to the risk that subsequent studies and ongoing or future clinical trials may not generate favorable data notwithstanding positive preclinical or early clinical result and the risks associated with the evolving nature of the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to it. Furthermore, many other important factors, including those described in Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 8, 2022 under “Item 3.D. Risk Factors” and those set forth in the universal registration document of Nanobiotix filed with the French Financial Markets Authority (Autorité des marchés financiers – the AMF) on April 8, 2022 (a copy of which is available on www.nanobiotix.com), as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Traditional Treatment Fails Some Elderly Head and Neck Cancer Patients, but NBTXR3 May Potentially Provide a New Option

What to Expect: From Diagnosis to Treatment for Head and Neck Cancer

Traditional Treatment Fails Some Elderly Head and Neck Cancer Patients, but NBTXR3 May Potentially Provide a New Option

The Nitty-Gritty of Head and Neck Cancer and Traditional Treatments

When Age Isn’t Just a Number

NBTXR3 is Being Evaluated as a Head and Neck Cancer Treatment for Elderly Patients

Important Information Regarding Forward-Looking Statements

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