New cancer therapies grabbing headlines

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Significant news in the development of cancer therapies during the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen that wraps up today.

Immunotherapies have led the way, headlined by MSD's KEYTRUDA (pembrolizumab) and Bristol-Myers Squibb's OPDIVO (nivolumab). A new Novartis breast cancer combination has also grabbed attention.

MSD announced results from two studies of KEYTRUDA in the first-line treatment of metastatic non-small cell lung cancer (NSCLC).

KEYTRUDA is currently PBS-listed for the treatment of melanoma. It will be considered for an expanded listing to include NSCLC at PBAC's November meeting.

In the KEYNOTE-024 trial, which evaluated squamous and non-squamous NSCLC patients whose tumours expressed high levels of PD-L1, KEYTRUDA provided a 50 per cent reduction in the risk of disease progression or death and a 40 per cent reduction in the risk of death compared to the current standard of care, chemotherapy.

In KEYNOTE-021, which included patients with metastatic non-squamous NSCLC regardless of PD-L1 expression, KEYTRUDA plus chemotherapy achieved a 55 per cent objective response rate compared to 29 per cent for chemotherapy alone, the standard of care, and reduced the risk of disease progression or death by 47 per cent.

“Chemotherapy has been the standard treatment for most patients with advanced non-small cell lung cancer for decades, but survival rates remain low,” said Dr Roger Perlmutter, president, Merck Research Laboratories. “Our new data suggest that KEYTRUDA treatment can offer meaningful improvement over chemotherapy in a broad array of patients. In this sense, these studies may represent a turning point in worldwide efforts to control lung cancer.”

The company said the KEYTRUDA clinical development program includes over 350 clinical trials across more than 30 tumour types. Over 100 trials include KEYTRUDA in combination with other cancer therapies.

BMS reported data from a number of trials involving OPDIVO, including more details of trials involving first-line use of OPDIVO in the treatment of NSCLC.

The new details confirmed the disappointing result in first-line NSCLC but the company announced data from a raft of other OPDIVO trials, including in renal cell carcinoma (mRCC) and quality-of-life data from a Phase 3 trial in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

The Phase 1 CheckMate-016 trial evaluated the safety and tolerability of OPDIVO at different doses as part of a regimen with YERVOY (ipilimumab), Pfizer's SUTENT (sunitinib) or Novartis' VOTRIENT (pazopanib), in previously treated and treatment-naïve patients with mRCC.

Results with two years of follow-up show patients treated with the OPDIVO and YERVOY combination recorded an overall response rate of 40.4 per cent.

"The overall survival rate at 12 months was 81% and 85% for OPDIVO 3 mg/kg plus YERVOY 1 mg/kg arm and OPDIVO 1 mg/kg plus YERVOY 3 mg/kg arm, respectively, and at 24 months was 67% and 70%, respectively," said the company in a statement.

BMS also announced new patient-reported quality-of-life data from the Phase 3 CheckMate-141 trial evaluating OPDIVO in patients with recurrent or metastatic squamous cell carcinoma of the head and neck after platinum therapy compared to investigator’s choice of therapy (methotrexate, docetaxel or cetuximab).

According to the company, "Outcome assessments showed OPDIVO stabilized patients’ symptoms and functioning, including physical, role and social functioning across three separate instruments. Both PD-L1 expressors and non-expressors treated with investigator’s choice of therapy experienced statistically significant worsening of patient-reported outcomes from baseline to week 15 versus OPDIVO. In addition, OPDIVO more than doubled the time to deterioration for most functional domains measured and significantly delayed the time to worsening symptoms of fatigue, dyspnea and insomnia, compared to investigator’s choice of therapy."

“Patients living with this form of advanced head and neck cancer often experience debilitating physiological effects as well as emotional and social challenges brought on by the condition despite current treatment options,” said Dr Kevin Harrington, Professor in Biological Cancer Therapies at The Institute of Cancer Research, London, and a Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust in London. “These patient-reported outcomes are encouraging, as they help us understand the potential for OPDIVO to impact important quality-of-life measures for this patient population.”

Novartis reported results from the Phase 3 MONALEESA-2 study showing investigational LEE011 (ribociclib) plus letrozole, more commonly known as brand name FEMARA, significantly extended progression-free survival compared to standard of care, letrozole as monotherapy, as a first-line treatment in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer.

"The results demonstrate that LEE011 plus letrozole reduced the risk of death or progression by 44% over letrozole alone," said the company in a statement. "The combination significantly improved PFS across all patient subgroups, regardless of disease characteristics or demographics. More than half of women with measurable disease taking LEE011 plus letrozole saw their tumor size shrink by at least 30% (overall response rate (ORR) in patients with measurable disease = 53% vs 37%, p=0.00028)."

"The MONALEESA-2 results show the combination of LEE011 plus letrozole represents a significant step forward in the management of HR+ metastatic breast cancer and, if approved, would be a major addition to the treatment options these patients have," said Dr Gabriel Hortobagyi, MD, Professor of Medicine, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center and MONALEESA-2 Principal Investigator. "Women living with metastatic breast cancer will be on treatment for the rest of their lives, so it is critical to find treatment options that effectively delay progression."