FDA Approves Lilly’s Advanced Lung, Thyroid Cancer Drug

Eli Lilly and Company recently announced the FDA approved Retevmo (selpercatinib), the a therapy specifically for the treatment of metastatic rearranged during transfection (RET) driven lung and thyroid cancers. 

Retevmo was approved under the FDA’s Accelerated Approval regulations for patients 12 years of age and older who require systemic therapy or who are radioactive iodine- refractory. The oral medicine can be given in doses of 120 mg or 160 mg based on weight, and taken twice daily.

"We are extremely proud of how quickly the combined Loxo Oncology and Lilly Oncology teams brought Retevmo to patients, further demonstrating our commitment to delivering life-changing medicines to people living with cancer,"  Anne White, president of Lilly Oncology, said in the announcement.

Retevmo entered clinical trials in May of 2017 and the recent approval of the drug represents the fastest timeline in the development of oncology medication. Lori J. Wirth, MD, medical director of head and neck cancers at Massachusetts General Hospital, believes that Retevmo may be a good treatment option for cancer patients.

"RET alterations account for the majority of medullary thyroid cancers and a meaningful percentage of other thyroid cancers. For patients living with these cancers, the approval of selpercatinib means they now have a treatment option that selectively and potently inhibits RET,” she said. 

The approval was based on the LIBRETTO-001 Phase 1/2 trial response rate (ORR) and duration of response (DoR). The trial found that there was a five percent discontinuation rate due to adverse reactions. The most common reactions were less than 25 percent and included increased aspartate aminotransferase, increased alanine aminotransferase, increased glucose, decreased leukocytes, edema, etc. 

The most frequent serious adverse reaction was pneumonia, which affected less than two percent of patients. 

Alexander Drilon, MD, acting chief of early drug development at Memorial Sloan Kettering Cancer Center and lead investigator for the clinical trial, stated that the majority of metastatic lung cancer patients experienced clinically meaningful responses when treated with selpercatinib. 

“We applaud the FDA for their leadership and collaboration, recognizing the importance of bringing a new therapy to patients with advanced or metastatic RET-driven lung and thyroid cancers,” White concluded.

FDA Clears AgenTus IND for Allogeneic iNKT Cell Therapy

FDA recently approved an IND application for an allogeneic iNKT cell therapy from AgenTus Therapeutics, a subsidiary of immune-oncology company, Agenus. The therapy was designed for the treatment of patients with cancer. 

The cell therapy also has the potential to clear SARS- CoV-2, controlling harmful inflammation. A clinical trial is expected in the second half of 2020.

"We are extremely pleased to rapidly advance our proprietary iNKT cell therapy to the clinic to combat cancer and also address the urgent COVID-19 pandemic," Walter Flamenbaum, MD, CEO of AgenTus Therapeutics, said in the announcement. 

"We expect our clinical trials to demonstrate the key features of agent-797 and the benefits of combinations of our allogeneic iNKTs with Agenus' pipeline of checkpoint antibodies in solid tumors."

AgenTus Therapeutics previously submitted a separate IND for the treatment of the novel coronavirus, which is expected to clear soon. Agenus stated that it may spin out AgenTus and issue a portion of its holding in AgenTus to Agentus shareholders in the form of a stock dividend. The final decision will be made by the end of 2020. 

"I am heartened by our team's efforts to rapidly advance our allogeneic iNKT cells to treat patients with cancer and COVID-19," said Garo Armen, MD, chairman and CEO of Agenus and Chairman of AgenTus Therapeutics.  

"Our iNKTs are streamlined for treating large numbers of patients from a single batch. They are manufactured without the need for genetic manipulation, are expected to suppress graft-versus-host disease, can be manufactured affordably, and are designed for quick access by patients."

FDA Grants Fast Track Designation For Omecamtiv Mecarbil For Heart Failure

Amgen and Cytokientics recently announced that FDA granted fast track designation for omecamtiv mecarbill, an activator being developed to treat chronic heart failure with reduced ejection fraction (HFrEF). 

The novel selective cardiac myosin activator, also known as cardiac myotrope, received the designation to expedite review of the drug intended for serious or life-threatening diseases or conditions. 

"This Fast Track designation represents an important milestone in the development of omecamtiv mecarbil," David M. Reese, MD, executive vice president of Research and Development at Amgen, said in the announcement. "Today, half of heart failure patients will die within five years of diagnosis, underscoring the urgent need for new therapies for this grievous condition."

Heart failure affects more than 64 million people worldwide^, and nearly half of individuals have reduced left ventricular function, Amgen said. HF is the leading cause of hospitalization and readmission in people age 65 and older.

GALACTIC-HF is one of the largest Phase 3 global cardiovascular outcomes studies in heart failure ever conducted. The study is designed to evaluate whether treatment with omecamtiv mecarbil, when added to standard of care, reduces the risk of heart failure events and CV death in patients with HFrEF. 

The clinical trial enrolled 8,256 patients in 35 countries who were either hospitalized at the time of enrollment for a primary reason of heart failure or had a hospitalization or emergency room visit for heart failure within one year prior to screening. 

"We are pleased that the FDA has granted Fast Track designation for omecamtiv mecarbil for the potential treatment of heart failure," said Robert I. Blum, president and chief executive officer of Cytokinetics. 

"The prevalence of heart failure is growing with our aging demographics, and GALACTIC-HF is designed to assess the clinical effects of our novel myosin activator in patients meaningfully at risk."

Dose selection for omecamtiv mecarbil in this study used a blood test. Trial results from GALACTIC-HF are expected in the fourth quarter of 2020.