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Checkpoint Therapeutics To Release Significant Drug Data At This Week's ESMO Congress

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Checkpoint Therapeutics To Release Significant Drug Data At This Week's ESMO Congress

With interim results from a pivotal clinical trial of its lead PD-L1 checkpoint inhibitor incoming, biotech firm Checkpoint Therapeutics (NASDAQ: CKPT) is poised to deliver an important update on the drug’s efficacy and tolerability in its initial indication as a potential treatment for cutaneous squamous cell carcinoma (CSCC) at this week’s European Society for Medical Oncology (ESMO) Virtual Congress.

Following up on a prior interview on the status of its leading immunotherapy product candidate, cosibelimab, Benzinga spoke with Checkpoint Therapeutics President and CEO James Oliviero about the progress of the pivotal trial in CSCC and the evolving regulatory landscape in which it’s being conducted.

According to Oliviero, “The ESMO data is going to include approximately half the patients of our ongoing pivotal study required to support an approval in metastatic CSCC. This is a meaningful interim update that is going to allow for better comparisons between cosibelimab and the PD-1 antibodies already approved in this indication.”

Early Results Prove Positive

Last year’s ESMO Congress saw Checkpoint deliver interim trial data on cosibelimab that revealed encouraging comparisons to existing PD-1 drugs on the market, specifically, Sanofi’s (NASDAQ: SNY) and Regeneron Pharmaceuticals, Inc.’s (NASDAQ: REGN) Libtayo and Merck, Inc’s (NYSE: MRK) Keytruda, which only this summer received FDA approval as a treatment for CSCC.

“Libtayo was approved in metastatic CSCC in September 2018 based upon 75 patients with an Objective Response Rate (ORR) of 47%,” said Oliviero. “More recently, in June 2020, the FDA approved Keytruda based upon 105 patients with an ORR of 34%, which established a lower threshold of ORR considered clinically meaningful to the FDA in this indication to support an approval. Cosibelimab’s initial interim results, presented last year at the 2019 ESMO Congress, were highly encouraging, with a 50% ORR in the first 14 patients of the planned 75-patient registration-enabling study.”

Oliviero explained how these results — as well as the subset of these patients that experienced a complete absence of cancer as a result of treatment, referred to as a “complete response”’ — will serve to define cosibelimab’s potential advantages over existing PD-1 therapies.

“We believe cosibelimab, differentiated by its two-fold mechanism of action, has the potential to not only generate the highest ORR in the class, but also the highest complete response rate. In their respective approval labels, Libtayo showed a 5% complete response rate and Keytruda showed a 4% complete response rate.  In comparison, the initial cosibelimab interim results from last year showed a 7% complete response rate, which we expect could increase further with more time on treatment. Patients want a chance to be cured by immunotherapy, and if cosibelimab can generate a complete response rate meaningfully higher than the approved therapies in CSCC, this would be very impactful to patients and the physicians who treat them.”

Pricing-In A Pricy Market

Those figures shed promising light on Checkpoint’s drug trial in a treatment category whose prices run as high as ~$165,000 per year and currently generate $25 billion in annual sales.

Because cosibelimab is being developed through a fast follower approach, Oliviero believes the drug will be well-positioned to compete with existing treatment options in the segment should it gain FDA approval. He projects that, based on preliminary results, cosibelimab has the potential to not only provide better clinical outcomes but also serve as a more affordable treatment option than those currently available.

“We plan to launch cosibelimab at a price substantially lower than the class of PD-1/PD-L1 antibodies available today. At a 50% discount to today’s prices for the PD-1/PD-L1 antibodies, Checkpoint is expected to generate over 90% gross profit margin, which is perfectly acceptable in our view,” explained Oliviero. “One would not expect big pharmaceutical companies to match Checkpoint’s lower pricing without the fear of losing billions in market capitalization from the reduced revenue in all their indications.”

Oliviero, continued, “Lower pricing for cosibelimab will not only benefit insurance companies and the healthcare system in general, but also reduce the potentially burdensome out-of-pocket costs patients must pay as coinsurance for the currently available PD-1/PD-L1 inhibitors, which can amount to as much as $2,000 per dose.”

Further Trials In Store

Looking beyond their planned ESMO announcements, Oliviero outlined Checkpoint’s anticipated timeline for cosibelimab, including the completion of the current CSCC trial as well as early and investigational trials for further indications.

Said Oliviero, “Following the interim data update this week at ESMO, we expect to complete enrollment in the metastatic CSCC study around year-end to provide the full top-line results by mid-2021, which if successful, should allow for the marketing approval application submission in metastatic CSCC. Checkpoint is also enrolling locally advanced CSCC patients (locally advanced is earlier stage than metastatic CSCC), which is expected to be the second CSCC indication for cosibelimab. Checkpoint also expects to initiate a Phase 3 registration study in non-small cell lung cancer next year to potentially further expand its use into an even larger multi-billion dollar indication.”

The 2020 ESMO Congress is scheduled to take place from Saturday, September 19th to Monday, September 21st.

 

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