Iovance Makes Significant Impact At ASCO 2019 Conference With Cancer Drug

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About: Iovance Biotherapeutics, Inc. (IOVA), Includes: BMY, MRK
by: Terry Chrisomalis
Summary

Iovance Therapeutics announces positive results for two phase 2 studies; one treating patients with advanced melanoma and one treating patients with advanced cervical cancer.

If final positive results are achieved in the pivotal phase 2 study using lifileucel to treat advanced melanoma, it could be a strong case for FDA approval.

Iovance re-engineers lymphocytes taken from a donor patient and turns them into strong aggressive tumor infiltrating lymphocytes that are able to target and destroy tumor cells.

The company is exploring a few studies combining some of its tumor infiltrating lymphocytes drugs in combination with Keytruda, which could possibly prove to be superior than TIL monotherapy alone.

Iovance Biotherapeutics (IOVA) had made a very large impact at ASCO 2019 and it was one of the clear winners for the medical conference. That's because it reported positive results from two of its studies. The positive results were made possible through the use of the biotech's Tumor infiltrating lymphocytes platform, which offers a very unique way of treating patients with advanced melanoma and advanced cervical cancer. The biotech made the case in that it holds the potential to possibly be superior over other currently available therapies for these patient populations.

Source

Impact Of New Therapy for Advanced Cervical Cancer

The first study presented at the ASCO 2019 medical conference is known as innovaTIL-04, which is a phase 2 study. This study recruited 27 patients with advanced cervical cancer who were treated with LN-145. It was noted that there was an objective response rate (ORR) of 44%. This ORR is broken down into 9 patients who achieved a partial response and then about 3 patients who obtained a complete response. When a 7.4-month median follow-up was done, it was noted that 10 patients still had a response and the median duration of response (DOR) was not yet reached. In my opinion, this data is very solid. There are two reasons why this data is impressive. The first reason being that these patients had gone through an average of about 2.4 prior lines of therapy. Despite receiving other prior treatments, these patients had failed to respond to them. On the other hand, when given LN-145, a few of these patients started to change to a complete response. Matter of fact, this study displayed an 11% complete response in this patient population. The second reason deals with what can be observed quite easily. These advanced cancer patients when given a second-line treatment, typically only achieve a DOR between 3 to 5 months. Treatment with LN-145 has already reached a 7.4-month median DOR, which as you can see is superior over other currently available therapies. Of course, this is still early data because it will have to be reproduced in a larger study with more patients. Still, the potential for Iovance having a drug that is possibly superior to other treatments currently available as a second-line therapy is substantial.

Pivotal Study Puts Iovance In Solid Spot

The other phase 2 study that was reported at the conference was the use of lifileucel in advanced melanoma. One item to immediately point out is that even though it is a phase 2 study, it is considered to be a pivotal one. If this study finishes with solid results, Iovance could possibly file for FDA approval in 2020. This phase 2 study is known as innovaTIL-01 and there were a total of 66 patients with unresectable stage IIIC/IV melanoma. In addition, these patients were also post PD-1 patients. Meaning, these patients had already gone through 3 prior PD-1 therapies and failed to achieve a response. At a follow-up assessment done at a median of 8.8 months, the DOR had not been reached. The impressive feat about this DOR achieved is that it has a large range. The range thus far is between 1.4+ months all the way to 19.8+ months. The solid finding to point out here is that patients typically respond with PD-1 therapies. You know about Merck (MRK) with Keytruda and Bristol-Myers Squibb (BMY) with Opdivo. Both of these PD-1 therapies have achieved highly significant clinical outcomes, but you know that this advanced melanoma population is in dire needs when they don't even respond after an average of about 3 prior therapies. The addition of adding TILs after such treatments can definitely help save patients' lives.

TIL Technology Drives The Company Forward

The positive results achieved above were on the basis for Iovance utilizing a strong technology platform. Specifically, it uses something known as tumor infiltrating lymphocytes (TILs). TILs are named so because they are lymphocytes, a type of protective response by the immune system, that infiltrates the tumor. The problem is that tumor cells create a microenvironment where they can avoid or sidestep TILs very easily. The way tumor cells do this is by quickly adapting with a change in environment and then being able to avoid TILs in a person's body. Iovance has developed a solid way of being able to overcome this issue. Consider that the first step of the process is to remove TILs from the person in question. After that is done, the numbers of TIL are expanded into billions by stimulating them ex-vivo in a tissue culture with IL-2. The second process works on addressing what I had highlighted above, which is taking out the immune-suppressive environment that is created by the tumor.

The immune system would be able to combat cancer tumor cells if not for the immune suppressive environment that typically hinders it. The final process involves turning the TILs into aggressive anti-tumor TILs. The significance of this is being able to re-administer them back into the patient and then allow them to destroy cancer cells. The two studies noted above, highlight the potential for generating such strong TILs to combat against multiple types of cancer. Having said that, LN-145 is also being explored to treat patients with head and neck cancer. As I always tend to state, cancer therapies are always stronger in combinations. Despite this highly positive clinical data achieved, Iovance is pushing a few studies with the use of Merck's Keytruda to target: Melanoma, non-small cell lung cancer (NSCLC) and head and neck cancer. Such a combination could possibly be ideal for boosting efficacy, maybe by even generating additional complete response rates.

Financials

According to the 10-Q SEC filing, Iovance Biotherapeutics has cash, cash equivalents, and short-term investments of $440 million as of March 31, 2019. The company has a large pipeline full of clinical candidates, especially the combination studies that it has ongoing right now as well. The biotech believes that it has enough cash to fund its operations for at least 12 months from the date of this SEC filing, which was filed May 7, 2019. That means it should have enough cash for at least May of 2020. The thing is that biotechs tend not to wait the last few months to raise cash. They typically raise cash at least 5 to 6 months before they run out. That means I believe a cash raise could be done in early 2020.

Conclusion

Iovance Biotherapeutics is in good shape after having proven that its technology can be successful in a few types of cancer. The ability for LN-145 to be successful in advanced cervical cancer and lifileucel in advanced melanoma will drive the company forward to a successful development pathway. Especially, when you consider that the phase 2 advanced melanoma study is considered a pivotal one. That means successful final results in this study could allow the biotech to file an NDA to the FDA for approval. The risk is that these studies are ongoing and safety will remain a top priority. Therefore, as long as no safety risks pop up anytime between now and completion of the studies, then things should look good on the approval front.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.