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PARP Inhibitor Resistance in Ovarian Cancer: We Need More Trials

By Brittany Cote
General Discussions - Discussions
49 replies
While PARP inhibitors have played a large part in improving progression-free survival (PFS) in patients with ovarian cancer, long-term use of these agents often leads to resistance that are often quite challenging to overcome, according to Gottfried E. Konecny, MD.

“We need to do studies that do biospecimen collection to analyze the reasons for the lack of efficacy of a PARP inhibitor but also to make intelligent decisions on how to treat them subsequently,” explained Konecny, an associate professor of medicine and lead clinician for gynecologic oncology in the Department of Medicine at the University of California, Los Angeles.

Several trials have come along examining the use of PARP inhibitors in the frontline treatment of recurrent ovarian cancer, but data are more limited when it comes to retreatment with PARP or what to do in those who develop acquired resistance to these agents. While there currently is no optimal strategy to overcome PARP resistance, methods such as repairing double-strand breaks by recovering homologous recombination proficiency, utilizing antiangiogenic agents, such as cediranib or bevacizumab (Avastin), and combining PARP inhibitors with immunotherapy are all possible options, added Konecny.

Future studies with biomarker research are additionally needed to overcome this unmet need.

“The bottom line is that there are more possible drug combinations,” said Konecny. “It is an effort of our laboratory to study these drug interactions to quantify the level of interaction and to follow leads that show pronounced synergy when combined with a PARP inhibitor and bring these to clinic as fast as possible, with the hope that [we] can overcome PARP resistance or restore the sensitivity to the drug.”​

In an interview with Oncology Nursing News' sister publication, OncLive® during the 2020 Institutional Perspectives in Cancer webinar on ovarian cancer, Konecny further discussed potential strategies to overcome PARP resistance, future combinations with PARP inhibitors, and other unmet needs in ovarian cancer.

OncLive®: What are the biggest challenges with PARP inhibitor resistance?

Konecny: The addition of PARP inhibitors to the treatment of patients with early-stage ovarian cancer and recurrent disease has made a very large impact on improving PFS. Recent data from the 2020 ESMO Virtual Congress showed an improvement in overall survival (OS), particularly in patients with BRCA1/2 mutations. Despite these successes, unfortunately, many patients face [progression on] these drugs over time. That leads us to focus on mechanisms of drug resistance and understanding how we can overcome these mechanisms of drug resistance.

About half of all ovarian cancers have an intrinsic primary drug resistance to PARP inhibitors, as they have a competent high-fidelity double-strand break repair mechanism that's intact. Single-strand break repair disruption through a PARP inhibitor is not that relevant in these cases because the backup DNA repair mechanism steps in and the drug does not work through synthetic lethality in these patients.

Of those patients who are initially deficient of double-strand break repair, we now understand that many patients can develop resistance by a recovery of double-strand break repair. That means recovery of homologous recombination, and this is due to demethylation of 1 of the silenced BRCA1 genes. It has also been described by an increase in copy numbers that occur during disease progression of either mutated or unmutated BRCA allele, which leads to an increased expression of the protein. Other mechanisms are secondary mutations that occur, particularly in those who have mutations in BRCA1/2.

[There] are very unique findings on how tumors can adapt to PARP inhibitor treatment by selecting cells that actually have the ability to splice out mutations or areas of the gene that contained the mutations and express an incomplete but partially functional BRCA1 or BRCA2 protein. This is basically alternative splicing of a hypomorphic BRCA1; that's particularly pertaining to exon 11, so if mutations are in exon 11, it can be that some of these cell clones splice out the mutation and they have restoration of homologous recombination.

Then, there is a large area where negative regulators of homologous recombination can be lost, and there is loss of negative regulators are basically involving the proteins 53BP1 or REV7. Beyond that, PARP inhibitors have shown to be effective by leading to the replication for degradation; PARP inhibitors also function not just through enzymatic inhibition of PARylationand recruiting DNA repair factors, but they blocks the replication fork and leads to its degradation.

There are a number of proteins that execute this degradation, and when you lose these executers that are supposed to complete the command of destroying the replication, then PTIP, MRE11, or EZH2 can also be lost. Therefore, a PARP inhibitor loses its ability to degrade the replication fork and gets less effective. Lastly, there are mechanisms, such as drug efflux pumps that just simply decrease the intracellular drug concentrations by pumping the drug out efficiently through the well-described P-glycoprotein pump, which is also responsible for chemotherapy resistance in many instances.

Currently, we don't have a good understanding of how clinically relevant these described mechanisms are. Many of them have been described in cell lines or preclinical models, and to date, it has only been demethylation of silence BRCA promoters over time, as well as increased copy numbers of the BRCA gene mutated or wild-type and secondary mutations that have been described in clinical samples. The remaining reasons for PARP resistance are preclinical. We need to do a better job in looking at samples and finding whether these mechanisms truly play an important clinical role.

What is the clinical relevance of reversing mutations?

Reversing mutations has been [found in] about 20% of patients who develop resistance to a PARP inhibitor. How do patients do after the occurrence of a reversion mutation? Some studies suggest that they do not respond to PARP inhibitors. A retrospective study from ARIEL2 showed cases that had a reversion mutation in the screening biopsy and responded poorly to the PARP inhibitor.

However, there are contrasting studies showing that if you have resistance to a PARP inhibitor, you still have a sensitivity towards platinum-based chemotherapy. A British study looked at the efficacy of chemotherapy after PARP inhibitor–failure. It shows an objective response rate of 45% and 49% if they were retreated with a platinum-[containing agent], suggesting that even with resistance mechanisms to a PARP inhibitor, they may still respond to a platinum-[containing agent].

That leads to the question: Are reversion mutations that clinically relevant? They should confer resistance to [a PARP inhibitor], but also platinum-based chemotherapy. Possibly, [if] you detect a reversion mutation, it may be pretty infrequent in the tumor. Some studies have shown that you can find a number of reversion mutations with different allele frequencies. That means they are only present in a small subsets of cells, indicating that this is a clonal selection process. You develop a reversion mutation and then it takes time until this population outgrows the otherwise sensitive cell lines. We don't understand what to make out of reversion mutations. We need more clinical studies to understand that.

How can these resistance mechanisms be overcome?

There are a number of theoretical approaches to overcome these resistance mechanisms and most of them pertain to mechanisms that are not geared toward overcoming genomic resistance, such as secondary mutations or a copy number changes. They’re geared towards affecting reversible recovery of homologous recombination. There are preclinical studies that have shown that when you add a MEK inhibitor, PI3K inhibitor, or epigenetic therapy to a PARP inhibitor that you can actually increase the DNA repair deficiency by downregulating the expression of proteins involved in double-strand break repair. You're actually switching a cell that is proficient in homologous recombination back into one that is homologous repair deficient. (HRD) This can be done by antiangiogenic agents. By simply inducing hypoxia in the tumor microenvironment, some studies have shown that that decreases the expression of proteins involved in double-strand break repair, and increases sensitivity towards PARP inhibitors again.

These are all hypotheses of ongoing clinical studies. Looking at combinations of various PARP inhibitors with either olaparib (Lynparza), niraparib (Zejula), rucaparib (Rubraca), or talazoparib (Talzenna), you can group them into 3 main groups. First, all of those drugs presumably increase DNA repair deficiency; then, there's another strategy that uses a group of drugs that just simply increases the amount of DNA damage. These are mostly inhibitors that interfere with remaining repair pathways. One important remaining pathway functions later in the cell cycle; there are numerous inhibitors in this pathway that may increase the activity of a single-agent PARP inhibitor. The Wee1, ATR, and ATM inhibitors are currently all in clinical trials.

Another strategy is to combine PARP with chemotherapy to overwhelm the DNA repair system. Most of these studies have to use low-dose chemotherapy because of the potentiation of cytotoxicity or myelotoxicity [GM5] with the combination. The last area of combination studies to overcome PARP inhibitor resistance or diminished activity is combining it with checkpoint inhibitors to leverage pathway interactions. Combining a checkpoint inhibitor with a PARP inhibitor doesn't restore or increase DNA damage or decrease the ability of DNA damage repair. It just means that those who are characterized by double-strand break repair deficiency may have some characteristics that suggest that they respond better to immunotherapy.

Could you expand on the rationale to combine PARP inhibitors with immunotherapy?

It makes sense to combine both approaches, and the data that have been published regarding that are threefold. When you have increased double-strand break repair, you have increased double-strand breaks. The cell recognizes this as a double-stranded viral DNA fragment, which induces an immune response mechanism, which triggers a signaling pathway called STING that then leads to an upregulation of interferon signaling and activation of immune cells. That is a well-described mechanism, suggesting that cells with increased HRD may respond better to immunotherapy. In addition, studies show that tumors with double-strand break repair deficiency, or those that are BRCA1/2 mutated, have higher neoantigen loads. A significantly higher neoantigen load has been associated with an improved response to immune therapy. There's great promise in the combination of PARP inhibitors with immune checkpoint inhibitors but, again, these studies are in early-phase testing.

Some examples are the MEDIOLA study, which showed outstanding activity with an over 70% response rate when combining olaparib with durvalumab (Imfinzi). Likewise, a similar study combining niraparib with pembrolizumab (Keytruda) showed promising activity; however, this was in predominantly BRCA wild-type tumors. These studies are leading the way and are the rationale for a number of frontline studies that are comparing PARP plus checkpoint inhibitors, such as ATHENA study or DUO-O.

If a patient has a certain type of resistance, is it too early in practice to direct them towards a chemotherapy/PARP combination versus an immunotherapy combination?

The only clinically useful way of detecting resistance markers right now are the reversion mutations. [This is] because we send specimens for sequencing and they suddenly reveal additional mutations in some alleles, or differences from the initial sequencing report. This can be done on tumor tissues and can now be done on circulating tumor DNA.

This is clinically available and it's still unclear what we should do as clinicians. Should we withhold the PARP inhibitor? Possibly or very likely. Should we withhold a platinum-based chemotherapy? We don't know that yet because there may not be a complete overlap in the resistance. These are questions that we have to address.

If [a patient] received a PARP inhibitor and if they have been on a PARP inhibitor for more than 6 months, it's worth trying retreatment with PARP as maintenance therapy. But, again, these are not unfounded suggestions; [they’re] not backed by clinical studies. These clinical studies are currently ongoing and a number of studies going forward, specifically in randomizing patients who were on a PARP maintenance therapy, have progressed, and have platinum-sensitive disease [are looking at] another line of platinum-based chemotherapy, and then rerandomizing them to either a PARP inhibitor again or a combination. For example, [this could be] a PARP inhibitor with another other cell cycle checkpoint inhibitor or placebo.

This article was originally published on OncLive as, "More Clinical Trials Needed to Overcome PARP Inhibitor Resistance in Ovarian Cancer."
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Known and Unknown Facts You Should Know About COVID 19

The new coronavirus is the disease-causing agent of the viral disease that has become a global pandemic, and it has induced the global economic recession. Known as COVID-19, this disease has threatened the public health in large-scale and forced the authorities across the world to go for the long-term lockdown to break its chain of progression. According to the UN Secretary-General, the situation due to the COVID-19 is reminding of the crises that had occurred during World War II. Globally, more than 16 lakhs people have been infected by this disease and it has caused over 82,000 deaths worldwide.

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The COVID-19 had its origin in the Chinese city of Wuhan in the last month of 2019 when the local health workers stated that this viral disease was passed from the animals to humans. Since then, it has spread to different countries across the world. At present, the disease is prevalent in over 100 countries across the world. Being a new virus, there is no specific vaccine or medicine available over-the-board to prevent this viral disease. Since December last year, there have been many attempts to understand the novel coronavirus. Despite the availability of a plethora of data available, it is not known much about this newly mutated coronavirus. In this article, we are going to walk you through some unknown things and facts about the virus.



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  1. This newly muted virus was first spotted in the Chinese city of Wuhan where the people got this virus from the products derived from cattle.
  2. Corona Virus is scientifically called as SARS-CoV-2.
  3. Since the disease was discovered in the year 2019, the World Health Organization (WHO) has christened it as COVID-19.
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After having gone through the known facts, let us now look at some unknown facts about this disease.

  1. Since there is no prescribed cure for the treatment of COVID-19, all the patients will get is the supportive treatment based on symptoms produced by them.
  2. The vaccines for the Corona Virus are being developed in countries like the U.S. and China. However, they are undergoing clinical trials in these countries, which is a mandatory step before getting approval from the local government agencies.
  3. A COVID-19-infected person on an average may pass on the virus to two or more people.
  4. Mainly old people, children below 10 years, and those persons who have weak immune systems and pre-existing medical conditions may develop serious illness. According to the doctors, people with heart problems, diabetes, high blood pressure, or previous lung infections might get serious illnesses due to exposure to this virus.
  5. When the affected person sneezes or coughs, the droplets that come out contain this virus. The virus particles present in air-suspended droplets remain virulent for about 3 hours in the airborne drop suspensions.
  6. Though the wearing of face masks does not guarantee 100% protection from the COVID-19 transmission, it is advisable for the persons infected with viruses to wear them to stop the spreading of cough or sneeze droplets in the air. Even the people with common cold and cough are advised to wear the face mask to avoid the spreading of the cough or sneeze droplets. Healthy people need not wear a mask.
  7. Though there is no data available to substantiate the re-occurrence of COVID-19 infection, there have been instances of people getting the infection after recovering completely from it once. For example, a Japanese woman was reported to have got the re-infection after recovering from it once.
  8. Despite the previously held beliefs that COVID-19 infection tends to slow down during summer seasons, there have been increased infections in all climate areas. That is why the WHO has made it clear that the transmission of this disease is not climate-dependent.
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  10. Though there is no evidence to suggest the spread of Corona Virus from pet cats or dogs, there has been a case involving a tiger at the zoo getting the COVID-19 infection. More data is required to substantiate this claim.
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Signs of a Successful Small Business Owner


When starting a new business, there are numerous signs that can indicate whether you're succeeding as an entrepreneur or aren't. A small business can be risky. This is particularly true if you specialize in a niche that bigger companies already excel in. However, if you display some particular qualities, it's a sign that you're doing a good job to stay afloat.

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You Like To Form Collaborations

Most successful entrepreneurs display this common trait. They understand the importance of having a well-connected network in the business world. Nevertheless, just like in every other change, collaboration needs to start from within your business. This means you'll need to start delegating tasks effectively. Another crucial part of this is building good relationships with everyone on your team. This includes your employees and suppliers.

Of course, you also need to establish a position in the network of small businesses. It's unwise to act alone without any partners. You needn't form friendly relationships with your competitors. However, at the least, you should be on good terms with other small businesses that complement yours. By obtaining a position in the community of other businesses, you'll be able to create new opportunities that can benefit others. Moreover, others can do the same for you. What results is a beneficial support system that allows all members to rely on one another.

You Have Your Eyes Set on the Future

You never know what the future holds, especially if it's for something as volatile as a new startup business. That's why successful entrepreneurs share a common characteristic of looking towards long-term future goals.

Some struggle to stay afloat amidst a rocky economic climate, and such desperate conditions can lead to business owners not looking farther than the near future. Such thoughts are understandable, but think of it this way; acting upon well-structured long-term goals at the same time as day-to-day tasks can ensure far more than financial stability and simple peace of mind.

Your Leverage the Benefit of Technology

Nowadays, when it comes to operating a small business, it all comes down to incorporating the use of technology, whether in marketing, management, or everything else. Technology and software have made it easier for entrepreneurs and small business owner to meet their goals, and now with services like Google AdWords and personal assistants, functions have become much more streamlined than ever before.

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You Love to Learn

You're never ready to run a business until you're prepared to improve yourself by learning from others. You may be determined to make it through with a method involving trial and error, but that costs precious resources; you need to start learning from others' success and failures. Data is the most powerful weapon that a business can possess because it helps you discover trends and important details.

If you aim to learn about what strategies lead to profitable ideas and which ones are just downright terrible, you'll be able to devise a solution of your own. The best way to fulfill your curiosity is to read and look into insights regarding management, marketing, customer satisfaction, and product quality. Archives can provide you with numerous researches and surveys conducted by different companies. While it isn't necessary that the results apply to your business, you're still bound to learn something.

You Don't Just Think; You Act

While we're at it, we might as well establish that being a smart business owner doesn't mean that you'll never have to take risks; it's merely the ability to take risks with confidence. "SKIP BAYLESS Biography" One sign that your business will soon see the light of success is that you don't just think, you also act when the time is right. This sign is associated with the confident ability to make good decisions, even if they're risky.

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